Back Pain Lower Back ChronicMeLoPeNCT07403500
Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
A study testing Spinal or peripheral manipulation of the lower back to treat lower back pain in people with Back Pain Lower Back Chronic, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Low back pain is the second most common reason for medical consultation in France and affects 60 to 80% of the working population. Patients with acute episodes of non-specific low back pain recover within 6 to 8 weeks, but recurrence is common and 7 to 10% of patients will experience persistent pain and disability for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Spinal or peripheral manipulation of the lower back to treat lower back pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients seeking treatment for low back pain present for less than 3 months, with an average intensity greater than 50 on a visual analog scale of 0-100 in the previous 48 hours.
- Patients able to complete online questionnaires.
- Patients who have given their free and informed consent.
- Patients who are affiliated with or beneficiaries of a health insurance plan.
Who cannot join
- Patients with a history of back surgery, undergoing corticosteroid or morphine treatment, with acute or chronic inflammatory diseases, with psychiatric illness, or with low back pain lasting more than 3 months.
- Patients who have already undergone spinal manipulation for low back pain with the investigator.
- Patients participating or having participated in a therapeutic or drug study in the 3 months prior to their inclusion in this protocol.
- Patients in a period of exclusion determined by another study.
- Patients under legal protection, guardianship, or conservatorship.
- Patients unable to give their consent.
- Patients for whom it is impossible to provide informed consent.
- Pregnant or breastfeeding patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nimes University Hospital
Nîmes, Gard, 30029
Alexis HOMS, Dr., +334.66.68.34.59, alexis.homs@chu-nimes.fr
Jean Olivier CHATEAU, Dr.
About this study
Official title: Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain. An Open-label Randomized Controlled Multicenter Trial.
Low back pain is the second most common reason for medical consultation in France and affects 60 to 80% of the working population. Patients with acute episodes of non-specific low back pain recover within 6 to 8 weeks, but recurrence is common and 7 to 10% of patients will experience persistent pain and disability for more than 3 months. Given their low efficacy and the risks associated with nonsteroidal anti-inflammatory drugs or opioids (nearly 60% of all opioids prescribed in the United States), the scientific literature does not support the use of pharmacological treatments. The international recommendations strongly suggest using non-pharmacological therapies, including physical exercise, rehabilitation, and spinal manipulation.Spinal manipulation (SM) is a common choice of therapy in primary care. In the patient's imagination "getting manipulated when in pain leads to heavy use of these manual therapies in a medical (manual medicine and medical osteopathy) or non-medical setting (manual therapy, osteopathy, and chiropractic). However, the evidence of effectiveness is weak in the chronic phase (only in the short term) and contradictory for the acute or subacute phases of low back pain. Pain and function are improved at 6 weeks, but the results are not clinically relevant. There is a lack of evidence regarding efficacy because the trials on spinal manipulations are of poor quality. A meta-analysis has recently reported that SMs are associated with a very limited risk of harm, making them a reasonable treatment option. Therefore, it seems necessary to demonstrate the specific effect of MVs in order to justify their use in primary care, support their wider use around the world, and reinforce recommendations for non-pharmacological treatment of low back pain.
Read the detailed description
Low back pain is a common musculoskeletal condition that affects 60 to 80% of the working population at least once in their lifetime. Patients with acute episodes of non-specific low back pain recover within 6 to 8 weeks, but recurrence is common and 7 to 10% of them will experience persistent pain and disability for more than 3 months. It is the second most common reason for medical consultation in France.
The scientific literature does not support the use of pharmacological treatments given their low efficacy and the risks associated with prescribing nonsteroidal anti-inflammatory drugs or opioids (which account for nearly 60% of all opioids prescribed in the United States). It is therefore easy to understand why the international recommendations strongly suggest using non-pharmacological therapies, including physical exercise, rehabilitation, and spinal manipulation.
Spinal manipulation (SM) is a very common therapy of choice in primary care, enjoying popularity beliefs rooted in the patient's imagination ("getting manipulated when you're in pain"), leading to heavy use of these manual therapies in a medical (manual medicine and medical osteopathy) or non-medical setting (manual therapy, osteopathy, and chiropractic). However, evidence of effectiveness is considered weak in the chronic phase (only in the short term) and contradictory for the acute or subacute phases of low back pain. Pain and function are improved at 6 weeks, but the results are not clinically relevant. The main reason for this lack of evidence is that efficacy trials concerning spinal manipulations are, at best, of poor quality for a number of reasons: SMs are very often combined with other strategies (exercises, medication, rehabilitation, etc.), which limits the assessment of a specific effect; manual therapies are very diverse, limiting comparability; the time required to assess the effects is often long (more than 4 weeks), comparable to the usual time required for pain to resolve; comparative trials are of low power, limiting the ability to demonstrate a difference; The use of a placebo comparator to test the effect of MV is not trivial and must be carefully defined, particularly for physicians who do not consider placebo to be an alternative in standard care. As far as we know, there has only been one RTC against placebo, the results of which were negative (n=240).
A meta-analysis has recently reported that SMs are associated with a very limited risk of harm, making them a reasonable treatment option. Therefore, it seems necessary to demonstrate the specific effect of MVs in order to justify their use in primary care, support their wider use around the world, and reinforce recommendations for non-pharmacological treatment of low back pain.
The hypothesis is that patients receiving spinal manipulations will experience greater pain relief in the short term (7 to 10 days after treatment) than patients receiving peripheral manipulations.
Patients in the experimental group (spinal manipulation) should also show improvement in their pain in the medium term, their functional abilities, their physical and work avoidance scores, catastrophizing, and the occurrence of lumbar flare-ups up to three months of follow-up.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Spinal or peripheral manipulation of the lower back to treat lower back pain
- Keywords
- Back, Pain, Chronic, Spinal manipulation
- Medical subject headings
- Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal or peripheral manipulation of the lower back to treat lower back painOther
Also called Physiotherapy
The patient will receive treatment for lower back pain (spinal or peripheral manipulation) according to their assignment group.
| Study group | Role | What they receive |
|---|---|---|
| SPINE MANIPULATION (SM) | Experimental | The physician determines the level(s) with segmental dysfunction(s), checks the conditions for performing MV (free directions of trunk movement, absence of red flags), which consists of a dynamic push at high speed and low amplitude, a lateral rotation push in flexion performed on one or more vertebral segments where minor intervertebral disturbances are located (patient lying on their side). The rationale behind this approach is to treat minor intervertebral disturbances causing lumbar pain by activating a reflex mechanism that allows muscle relaxation. Receives: Other: Spinal or peripheral manipulation of the lower back to treat lower back pain |
| PERIPHERAL MANIPULATION (PM) | Active comparator | The doctor determines the level(s) with segmental dysfunction(s), then performs peripheral treatment using osteopathic techniques, offering comprehensive treatment for the patient. Mobilization and palpation are localized in the lower limbs (knee and ankle), the abdomen with massage of the psoas muscles, the upper limbs (shoulder and elbow), and the cervical spine with high-amplitude, low-speed mobilization without thrusting. The rationale behind this approach is the treatment of an overall imbalance causing back pain and requiring rebalancing. Receives: Other: Spinal or peripheral manipulation of the lower back to treat lower back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
Measured: Day 0
Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
Measured: Day 7
Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
Measured: Day 10
Short-term effectiveness (7 to 10 days) of peripheral manipulation (PM) on pain over the last 24/48 hours in acute and subacute low back pain : control group
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
Measured: Day 0
Short-term effectiveness (7 to 10 days) of peripheral manipulation (PM) on pain over the last 24/48 hours in acute and subacute low back pain : control group
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
Measured: Day 7
Short-term effectiveness (7 to 10 days) of peripheral manipulation (PM) on pain over the last 24/48 hours in acute and subacute low back pain : control group
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
Measured: Day 10
Secondary outcomes (54)
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Measured: Day 1 to 2
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Measured: Day 1 to 2
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Measured: Day 7 - 10
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Measured: Day 7 - 10
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Measured: Week 3
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Measured: Week 3
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Measured: Month 1
Evolution of lower back pain and lower limb pain (above the knee) in the control group group (PM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Measured: Month 1
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Measured: Month 3
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Measured: Month 3
Changes in movement avoidance due to pain in the experimental group (SM)
Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.
Measured: Day 0
Changes in movement avoidance due to pain in the experimental group (SM)
Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.
Measured: Day 7 to 10
Changes in movement avoidance due to pain in the experimental group (SM)
Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.
Measured: Month 1
Changes in movement avoidance due to pain in the experimental group (SM)
Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.
Measured: Month 3
Changes in movement avoidance due to pain in the control group (PM)
Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.
Measured: Day 0
Changes in movement avoidance due to pain in the control group (PM)
Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.
Measured: Day 7 to 10
Changes in movement avoidance due to pain in the control group (PM)
Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.
Measured: Month 1
Changes in movement avoidance due to pain in the control group (PM)
Measured according to the Fear Avoidance Beliefs Questionnaire (FABQ) score for physical avoidance and work avoidance. The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24). The questionnaire takes approximately 10 minutes to complete.
Measured: Month 3
Catastrophizing in the experimental group (SM)
Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.
Measured: Day 0
Catastrophizing in the experimental group (SM)
Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.
Measured: Day 7 to 10
Catastrophizing in the experimental group (SM)
Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.
Measured: Month 1
Catastrophizing in the experimental group (SM)
Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.
Measured: Month 3
Catastrophizing in the control group (PM)
Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.
Measured: Day 0
Catastrophizing in the control group (PM)
Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.
Measured: Day 7 to 10
Catastrophizing in the control group (PM)
Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.
Measured: Month 1
Catastrophizing in the control group (PM)
Catastrophizing will be measured using the PCS (Pain Catastrophizing Scale). The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Subscale Scores: Rumination: Items 8,9,10,11 Magnification: Items 6,7,13 Helplessness: Items 1,2,3,4,5,12. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.
Measured: Month 3
Occurrence and frequency of lumbar flare-ups in the 3 months following manipulation in the experimental group (SM)
The number of flare-ups, defined as episodes of low back pain greater than 50 out of 100 on the visual analog scale lasting more than 24 hours will be recorded. yes/no and if so, how many? Data collection via an online application made available to the patient.
Measured: Month 1
Occurrence and frequency of lumbar flare-ups in the 3 months following manipulation in the experimental group (SM)
The number of flare-ups, defined as episodes of low back pain greater than 50 out of 100 on the visual analog scale lasting more than 24 hours will be recorded. yes/no and if so, how many? Data collection via an online application made available to the patient.
Measured: Month 3
Occurrence and frequency of lumbar flare-ups in the 3 months following manipulation in the control group (PM)
The number of flare-ups, defined as episodes of low back pain greater than 50 out of 100 on the visual analog scale lasting more than 24 hours will be recorded. yes/no and if so, how many? Data collection via an online application made available to the patient.
Measured: Month 1
Occurrence and frequency of lumbar flare-ups in the 3 months following manipulation in the control group (PM)
The number of flare-ups, defined as episodes of low back pain greater than 50 out of 100 on the visual analog scale lasting more than 24 hours will be recorded. yes/no and if so, how many? Data collection via an online application made available to the patient.
Measured: Month 3
Functional disability in the experimental group (SM)
Functional disability will be measured according to the Roland Morris Disability Questionnaire (RMDQ). The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore range from 0 to 24. The original version of the Roland Morris Disability Questionnaire was published by Roland and Morris in 1983. A review of articles on the questionnaire was published in 2000 (Roland \& Fairbank 2000). It comprises 24 items and measures the functional disability of patients with low back pain. This self-administered questionnaire is quick, easy to use, reliable, valid, and sensitive to changes in clinical status, suggesting that its use could be generalized in contexts ranging from epidemiological or clinical research to the individual assessment of patients with low back pain in everyday clinical practice. The questionnaire takes approximately 5 minutes to complete.
Measured: Day 0
Functional disability in the experimental group (SM)
Functional disability will be measured according to the Roland Morris Disability Questionnaire (RMDQ). The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore range from 0 to 24. The original version of the Roland Morris Disability Questionnaire was published by Roland and Morris in 1983. A review of articles on the questionnaire was published in 2000 (Roland \& Fairbank 2000). It comprises 24 items and measures the functional disability of patients with low back pain. This self-administered questionnaire is quick, easy to use, reliable, valid, and sensitive to changes in clinical status, suggesting that its use could be generalized in contexts ranging from epidemiological or clinical research to the individual assessment of patients with low back pain in everyday clinical practice. The questionnaire takes approximately 5 minutes to complete.
Measured: Month 1
Functional disability in the experimental group (SM)
Functional disability will be measured according to the Roland Morris Disability Questionnaire (RMDQ). The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore range from 0 to 24. The original version of the Roland Morris Disability Questionnaire was published by Roland and Morris in 1983. A review of articles on the questionnaire was published in 2000 (Roland \& Fairbank 2000). It comprises 24 items and measures the functional disability of patients with low back pain. This self-administered questionnaire is quick, easy to use, reliable, valid, and sensitive to changes in clinical status, suggesting that its use could be generalized in contexts ranging from epidemiological or clinical research to the individual assessment of patients with low back pain in everyday clinical practice. The questionnaire takes approximately 5 minutes to complete.
Measured: Month 3
Functional disability in the control group (PM)
Functional disability will be measured according to the Roland Morris Disability Questionnaire (RMDQ). The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore range from 0 to 24. The original version of the Roland Morris Disability Questionnaire was published by Roland and Morris in 1983. A review of articles on the questionnaire was published in 2000 (Roland \& Fairbank 2000). It comprises 24 items and measures the functional disability of patients with low back pain. This self-administered questionnaire is quick, easy to use, reliable, valid, and sensitive to changes in clinical status, suggesting that its use could be generalized in contexts ranging from epidemiological or clinical research to the individual assessment of patients with low back pain in everyday clinical practice. The questionnaire takes approximately 5 minutes to complete.
Measured: Day 0
Functional disability in the control group (PM)
Functional disability will be measured according to the Roland Morris Disability Questionnaire (RMDQ). The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore range from 0 to 24. The original version of the Roland Morris Disability Questionnaire was published by Roland and Morris in 1983. A review of articles on the questionnaire was published in 2000 (Roland \& Fairbank 2000). It comprises 24 items and measures the functional disability of patients with low back pain. This self-administered questionnaire is quick, easy to use, reliable, valid, and sensitive to changes in clinical status, suggesting that its use could be generalized in contexts ranging from epidemiological or clinical research to the individual assessment of patients with low back pain in everyday clinical practice. The questionnaire takes approximately 5 minutes to complete.
Measured: Month 1
Functional disability in the control group (PM)
Functional disability will be measured according to the Roland Morris Disability Questionnaire (RMDQ). The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore range from 0 to 24. The original version of the Roland Morris Disability Questionnaire was published by Roland and Morris in 1983. A review of articles on the questionnaire was published in 2000 (Roland \& Fairbank 2000). It comprises 24 items and measures the functional disability of patients with low back pain. This self-administered questionnaire is quick, easy to use, reliable, valid, and sensitive to changes in clinical status, suggesting that its use could be generalized in contexts ranging from epidemiological or clinical research to the individual assessment of patients with low back pain in everyday clinical practice. The questionnaire takes approximately 5 minutes to complete.
Measured: Month 3
Pain management in the experimental group (SM)
The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.
Measured: In the week prior to inclusion
Pain management in the control group (PM)
The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.
Measured: In the week prior to inclusion
Pain management in the experimental group (SM)
The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.
Measured: Day 7 - 10 days
Pain management in the control group (PM)
The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.
Measured: Day 7 - 10 days
Pain management in the experimental group (SM)
The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.
Measured: Week 3
Pain management in the control group (PM)
The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.
Measured: Week 3
Pain management in the experimental group (SM)
The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.
Measured: Month 1
Pain management in the control group (PM)
The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.
Measured: Month 1
Pain management in the experimental group (SM)
The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.
Measured: Month 3
Pain management in the control group (PM)
The use of analgesics (Non-steroidal anti-inflammatory drugs, painkillers), lumbar braces, or osteopathic interventions will be recorded.
Measured: Month 3
Need for a second consultation in the experimental group (SM)
The need for a second consultation with the manual physician within one month of the first consultation will be recorded
Measured: Day 0 to Month 1
Need for a second consultation in the control group (PM)
The need for a second consultation with the manual physician within one month of the first consultation will be recorded
Measured: Day 0 to Month 1
Number of medical visits in the experimental group (SM)
The number of medical visits made by the patient as part of their treatment for low back pain at each follow-up visit will be recorded
Measured: Day 7 - 10
Number of medical visits in the control group (PM)
The number of medical visits made by the patient as part of their treatment for low back pain at each follow-up visit will be recorded
Measured: Day 7 - 10
Number of medical visits in the experimental group (SM)
The number of medical visits made by the patient as part of their treatment for low back pain at each follow-up visit will be recorded
Measured: Month 1
Number of medical visits in the control group (PM)
The number of medical visits made by the patient as part of their treatment for low back pain at each follow-up visit will be recorded
Measured: Month 1
Number of medical visits in the experimental group (SM)
The number of medical visits made by the patient as part of their treatment for low back pain at each follow-up visit will be recorded
Measured: Month 3
Number of medical visits in the control group (PM)
The number of medical visits made by the patient as part of their treatment for low back pain at each follow-up visit will be recorded
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start28 May 2026
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403500
- Sponsor's protocol ID
- RESPIR/2022/AD-01
- Acronym
- MeLoPe
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain. An Open-label Randomized Controlled Multicenter Trial.
- ClinicalTrials.gov ID
- NCT07403500
- Acronym / sponsor ID
- MeLoPe / RESPIR/2022/AD-01
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- Back, Pain, Chronic, Spinal manipulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 28 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low back pain is the second most common reason for medical consultation in France and affects 60 to 80% of the working population. Patients with acute episodes of non-specific low back pain recover within 6 to 8 weeks, but recurrence is common and 7 to 10% of patients will experience persistent pain and disability for more than 3 months. Given their low efficacy and the risks associated with nonsteroidal anti-inflammatory drugs or opioids (nearly 60% of all opioids prescribed in the United States), the scientific literature does not support the use of pharmacological treatments. The international recommendations strongly suggest using non-pharmacological therapies, including physical exercise, rehabilitation, and spinal manipulation.Spinal manipulation (SM) is a common choice of therapy in primary care. In the patient's imagination "getting manipulated when in pain leads to heavy use of these manual therapies in a medical (manual medicine and medical osteopathy) or non-medical setting (manual therapy, osteopathy, and chiropractic). However, the evidence of effectiveness is weak in the chronic phase (only in the short term) and contradictory for the acute or subacute phases of low back pain. Pain and function are improved at 6 weeks, but the results are not clinically relevant. There is a lack of evidence regarding efficacy because the trials on spinal manipulations are of poor quality. A meta-analysis has recently reported that SMs are associated with a very limited risk of harm, making them a reasonable treatment option. Therefore, it seems necessary to demonstrate the specific effect of MVs in order to justify their use in primary care, support their wider use around the world, and reinforce recommendations for non-pharmacological treatment of low back pain.
Detailed description
Low back pain is a common musculoskeletal condition that affects 60 to 80% of the working population at least once in their lifetime. Patients with acute episodes of non-specific low back pain recover within 6 to 8 weeks, but recurrence is common and 7 to 10% of them will experience persistent pain and disability for more than 3 months. It is the second most common reason for medical consultation in France.
The scientific literature does not support the use of pharmacological treatments given their low efficacy and the risks associated with prescribing nonsteroidal anti-inflammatory drugs or opioids (which account for nearly 60% of all opioids prescribed in the United States). It is therefore easy to understand why the international recommendations strongly suggest using non-pharmacological therapies, including physical exercise, rehabilitation, and spinal manipulation.
Spinal manipulation (SM) is a very common therapy of choice in primary care, enjoying popularity beliefs rooted in the patient's imagination ("getting manipulated when you're in pain"), leading to heavy use of these manual therapies in a medical (manual medicine and medical osteopathy) or non-medical setting (manual therapy, osteopathy, and chiropractic). However, evidence of effectiveness is considered weak in the chronic phase (only in the short term) and contradictory for the acute or subacute phases of low back pain. Pain and function are improved at 6 weeks, but the results are not clinically relevant. The main reason for this lack of evidence is that efficacy trials concerning spinal manipulations are, at best, of poor quality for a number of reasons: SMs are very often combined with other strategies (exercises, medication, rehabilitation, etc.), which limits the assessment of a specific effect; manual therapies are very diverse, limiting comparability; the time required to assess the effects is often long (more than 4 weeks), comparable to the usual time required for pain to resolve; comparative trials are of low power, limiting the ability to demonstrate a difference; The use of a placebo comparator to test the effect of MV is not trivial and must be carefully defined, particularly for physicians who do not consider placebo to be an alternative in standard care. As far as we know, there has only been one RTC against placebo, the results of which were negative (n=240).
A meta-analysis has recently reported that SMs are associated with a very limited risk of harm, making them a reasonable treatment option. Therefore, it seems necessary to demonstrate the specific effect of MVs in order to justify their use in primary care, support their wider use around the world, and reinforce recommendations for non-pharmacological treatment of low back pain.
The hypothesis is that patients receiving spinal manipulations will experience greater pain relief in the short term (7 to 10 days after treatment) than patients receiving peripheral manipulations.
Patients in the experimental group (spinal manipulation) should also show improvement in their pain in the medium term, their functional abilities, their physical and work avoidance scores, catastrophizing, and the occurrence of lumbar flare-ups up to three months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPINE MANIPULATION (SM) | Experimental | Other: Spinal or peripheral manipulation of the lower back to treat lower back painThe physician determines the level(s) with segmental dysfunction(s), checks the conditions for performing MV (free directions of trunk movement, absence of red flags), which consists of a dynamic push at high speed and low amplitude, a lateral rotation push in flexion performed on one or more vertebral segments where minor intervertebral disturbances are located (patient lying on their side). The rationale behind this approach is to treat minor intervertebral disturbances causing lumbar pain by activating a reflex mechanism that allows muscle relaxation. |
| PERIPHERAL MANIPULATION (PM) | Active comparator | Other: Spinal or peripheral manipulation of the lower back to treat lower back painThe doctor determines the level(s) with segmental dysfunction(s), then performs peripheral treatment using osteopathic techniques, offering comprehensive treatment for the patient. Mobilization and palpation are localized in the lower limbs (knee and ankle), the abdomen with massage of the psoas muscles, the upper limbs (shoulder and elbow), and the cervical spine with high-amplitude, low-speed mobilization without thrusting. The rationale behind this approach is the treatment of an overall imbalance causing back pain and requiring rebalancing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients seeking treatment for low back pain present for less than 3 months, with an average intensity greater than 50 on a visual analog scale of 0-100 in the previous 48 hours.
- Patients able to complete online questionnaires.
- Patients who have given their free and informed consent.
- Patients who are affiliated with or beneficiaries of a health insurance plan.
Key exclusion criteria (8 listed)
- Patients with a history of back surgery, undergoing corticosteroid or morphine treatment, with acute or chronic inflammatory diseases, with psychiatric illness, or with low back pain lasting more than 3 months.
- Patients who have already undergone spinal manipulation for low back pain with the investigator.
- Patients participating or having participated in a therapeutic or drug study in the 3 months prior to their inclusion in this protocol.
- Patients in a period of exclusion determined by another study.
- Patients under legal protection, guardianship, or conservatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal or peripheral manipulation of the lower back to treat lower back painAlso: PhysiotherapyThe patient will receive treatment for lower back pain (spinal or peripheral manipulation) according to their assignment group. | Other | PERIPHERAL MANIPULATION (PM), SPINE MANIPULATION (SM) |
Primary outcome
Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group
Time frame: Day 0
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group
Time frame: Day 7
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group
Time frame: Day 10
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
Short-term effectiveness (7 to 10 days) of peripheral manipulation (PM) on pain over the last 24/48 hours in acute and subacute low back pain : control group
Time frame: Day 0
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
Short-term effectiveness (7 to 10 days) of peripheral manipulation (PM) on pain over the last 24/48 hours in acute and subacute low back pain : control group
Time frame: Day 7
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
Short-term effectiveness (7 to 10 days) of peripheral manipulation (PM) on pain over the last 24/48 hours in acute and subacute low back pain : control group
Time frame: Day 10
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
54 secondary outcomes
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)
Time frame: Day 1 to 2
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)
Time frame: Day 1 to 2
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)
Time frame: Day 7 - 10
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)
Time frame: Day 7 - 10
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)
Time frame: Week 3
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)
Time frame: Week 3
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)
Time frame: Month 1
Evolution of lower back pain and lower limb pain (above the knee) in the control group group (PM)
Time frame: Month 1
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)
Time frame: Month 3
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)
Time frame: Month 3
Changes in movement avoidance due to pain in the experimental group (SM)
Time frame: Day 0
Changes in movement avoidance due to pain in the experimental group (SM)
Time frame: Day 7 to 10
Changes in movement avoidance due to pain in the experimental group (SM)
Time frame: Month 1
Changes in movement avoidance due to pain in the experimental group (SM)
Time frame: Month 3
Changes in movement avoidance due to pain in the control group (PM)
Time frame: Day 0
Changes in movement avoidance due to pain in the control group (PM)
Time frame: Day 7 to 10
Changes in movement avoidance due to pain in the control group (PM)
Time frame: Month 1
Changes in movement avoidance due to pain in the control group (PM)
Time frame: Month 3
Catastrophizing in the experimental group (SM)
Time frame: Day 0
Catastrophizing in the experimental group (SM)
Time frame: Day 7 to 10
Catastrophizing in the experimental group (SM)
Time frame: Month 1
Catastrophizing in the experimental group (SM)
Time frame: Month 3
Catastrophizing in the control group (PM)
Time frame: Day 0
Catastrophizing in the control group (PM)
Time frame: Day 7 to 10
Catastrophizing in the control group (PM)
Time frame: Month 1
Catastrophizing in the control group (PM)
Time frame: Month 3
Occurrence and frequency of lumbar flare-ups in the 3 months following manipulation in the experimental group (SM)
Time frame: Month 1
Occurrence and frequency of lumbar flare-ups in the 3 months following manipulation in the experimental group (SM)
Time frame: Month 3
Occurrence and frequency of lumbar flare-ups in the 3 months following manipulation in the control group (PM)
Time frame: Month 1
Occurrence and frequency of lumbar flare-ups in the 3 months following manipulation in the control group (PM)
Time frame: Month 3
Functional disability in the experimental group (SM)
Time frame: Day 0
Functional disability in the experimental group (SM)
Time frame: Month 1
Functional disability in the experimental group (SM)
Time frame: Month 3
Functional disability in the control group (PM)
Time frame: Day 0
Functional disability in the control group (PM)
Time frame: Month 1
Functional disability in the control group (PM)
Time frame: Month 3
Pain management in the experimental group (SM)
Time frame: In the week prior to inclusion
Pain management in the control group (PM)
Time frame: In the week prior to inclusion
Pain management in the experimental group (SM)
Time frame: Day 7 - 10 days
Pain management in the control group (PM)
Time frame: Day 7 - 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal or peripheral manipulation of the lower back to treat lower back pain in people with Back Pain Lower Back Chronic, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnaud DUPEYRON, Professor (+33 4.66.68.34.59, arnaud.dupeyron@umontpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group (time frame: Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.