Chronic Low-back PainNCT04940715
Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain
A study testing Passive joint mobilization and Mobilization with movement in people with Chronic Low-back Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Patients with chronic low back pain may have altered pain processing, making them vulnerable to pain or disability. It can be measured with test like pressure pain threshold, temporal summation or conditioned pain modulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Passive joint mobilization and Mobilization with movement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2021to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-specific chronic low back pain patients, without lower limb pain
- Pain lasting 6 months or more
- Pain measure of 2 or more on a 0 to 10 scale
- Age between 18-65 years old
- Haven't received physical therapy during last month
Who cannot join
- Radiculopathy
- Neurological signs, symptoms or deficit
- Rheumatic/autoimmune/systemic disease
- History of fracture, trauma or previous spinal surgery
- Pregnancy
- Disc herniation
Show all 11Show fewer
- Neuropathic pain
- Active cancer
- Spondylolysis/Spondylolisthesis
- Cognitive impairment
- Long-term opioid intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain: a Double-blinded, Randomized Clinical Trial.
Patients with chronic low back pain may have altered pain processing, making them vulnerable to pain or disability. It can be measured with test like pressure pain threshold, temporal summation or conditioned pain modulation. Manual therapy has shown improve this pain processing variables in other conditions (like knee osteoarthritis or lateral elbow pain), although the quality of the evidence is low in terms of temporal summation and controversial in terms of conditioned pain modulation. There are not studies that had investigated the impact of manual therapy techniques on pain processing in patients with chronic low back pain.
Read the detailed description
Study Aims:
Aim #1: The main objective of this study is to determine the efficacy of two manual therapy approaches (passive joint mobilization and mobilization with movement) on pain (measured with Visual Analogue Scale) and pain processing (measured with pressure pain threshold, temporal summation and conditioned pain modulation) in patients with chronic low back pain and see its results on short, medium and long term.
Aim #2: The secondary objective is to compare the effect of both manual therapy techniques with an inactive control group in terms of pain and pain processing.
Aim #3: Determine the efficacy of manual therapy on intervention groups on psychological outcomes as catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale of Kinesiophobia) and depression (Beck Depressive Inventory) and compare them with control group.
Methodology Research Design: Randomized, longitudinal, experimental, prospective, parallel and double-blind study with patients with chronic low back pain.
Participants: Adults between 18-65 years old residing Comunidad de Madrid, all of whom were recruited personally for the study. All patients will read the information sheet explaining what the study will consist, as well as the informed consent form, which they will sign voluntarily beforehand.
Sample Size: The sample size will be calculated by means of the "Gpower 3.0.18" computer program.
Randomization: Randomization will be done through the GraphPad software (GraphPad Software, Inc CA 92037 USA). Patients who meet the inclusion criteria and have none of the exclusion criteria will be entered into the study and the sample will be randomized to obtain three groups in opaque and sealed envelopes: A (passive joint mobilization), B (mobilization with movement) and C (control group).
Masking: The double-blind criteria are met, in which the subjects participating in the study will not know the group to which they were assigned, as well as the physiotherapist in charge of collecting the outcomes data.
- Conditions
- Chronic Low-back Pain
- Being tested
- Passive joint mobilization, Mobilization with movement
- Keywords
- Chronic low back pain, Pain processing, Manual Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive joint mobilizationOther
Dosage: 5 sets of 2 minutes with 30 seconds of rest were applied, with a strong force (>50% of maximum therapist strength), according to patient's irritability and severity.
Mobilization with movementOther
Dosage: 3 sets of 10 repetitions were performed, with 1-2 minutes of rest between sets.
| Study group | Role | What they receive |
|---|---|---|
| Passive joint mobilization | Experimental | Patients lay down on a prone position, with their hands around the body and neck placed comfortable. The therapist performed a postero-anterior joint mobilization using Maitland's technique, applying pressure to spinous process of targeted vertebra (the one who reproduces patient's symptoms). Receives: Other: Passive joint mobilization |
| Mobilization with movement | Experimental | Patients perform their painful movement (flexion, extension…). If pain wasn't reproduced, a combination of movements will be performed (flexion + rotation…). The most painful vertebral level was assessed too with passive accessory vertebral movements. Afterwards, with the patient on a seated position on a stretcher with feet supported and a belt around the waist, the therapist performed a sustained glide on the targeted vertebra (spinous process) with the force and direction that relieved pain to the lowest level. Receives: Other: Mobilization with movement |
| Control group | No intervention | Patients were measured at baseline and then were placed on "wait list" until the end of the study. At this time, they were measured again. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual Analogue Scale (VAS) was used to measure pain. It consists of a 100mm length line and has written "no pain" and "worst pain imaginable" on its ends and measures pain intensity. The confidence and reliability of this scale has been approved and validated in different studies.
Measured: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
Pressure pain threshold
A digital algometer was used to measure mechanical hyperalgesia. The model was de X® brand, consisting of a 1cm2 cylindrical rubber attached to a pressure gauge, calibrated in kilograms (kg). The scale expressed in kg/cm2 was used. Before the measurement, patients were trained in forearm muscles through a trial session. They were instructed to say STOP when the pressure sensation was painful. For the measurement, patients lay down on prone position on the stretcher and the algometer was placed perpendicular to skin on the measured points, who were marked prior to measurement (2cm lateral to L5 spinous process, C2 spinous process, ipsilateral anterior tibialis and contralateral epicondyle). A rest period of 30 seconds was established between the measurements. For each point, three measurements were done and their mean was calculated and recorded for analysis. The minimum detectable change (CMD) for considering the results as clinically relevant was established at 15% minimum.
Measured: Time Frame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
Temporal summation
Temporal summation was measured with Von Frey monofilaments. Patients lay down on prone position and measurements were taken 1cm lateral to spinous process of L4. First, a single stimulus was applied and the patient assessed the pain intensity on a 0-10 numeric rating scale. After that, 10 rhythmic stimuli were applied on the same spot (1 stimuli per second) and the patient assessed again the pain intensity. The temporal summation effect was calculated as the difference between the mean rating of the three repetitions of one stimulus and the mean rating of the three repetitions of 10 stimulus.
Measured: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
Conditioned pain modulation
Conditioned pain modulation was measured with tourniquet test. A sphygmomanometer was used to induce ischemic muscle pain as conditioning stimulus (model X®). It was applied around the contralateral upper arm, 3cm proximal to cubital fossa. Now, pressure pain threshold 2cm lateral to L5 spinous process was measured. Afterwards, the cuff was inflated to 260mmHg and maintained until the patient perceived a pain intensity of 6 on a 0-10 numeric rating pain scale. Then, the pressure pain threshold was measured again at the same spot during the conditioning stimulus and then the cuff pressure was released. The conditioned pain modulation value is the result of the subtraction of the value of the PPT during the conditioning stimulus minus the PPT without it.
Measured: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
Secondary outcomes (5)
Pain Catastrophizing
Catastrophism was measured with Spanish version of Pain Catastrophizing Scale. It's a 13-item self-report measure of catastrophizing and it's constructs as rumination, magnification and helplessness. It must be answered by numeric values between 0 (not at all) and 4 (all the time), with a maximum score of 52 points. The minimal detectable change was identified at 9.1 points.
Measured: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
Kinesiophobia
Fear of movement was measured with Spanish version of Tampa Scale of Kinesiophobia. It's an 11-item self-report questionnaire to assess fear of movement-related pain. It's divided on two subscales, one related to Fear of Activity and the other related to Fear of Harm. The score ranges between 11-44 points, with higher scores associated with greater kinesiophobia. The minimal detectable change score was 5.6.
Measured: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
Depression
Depressive symptoms were measured with Spanish version of Beck Depressive Inventory. It's a 21-item self-report questionnaire to identify symptoms associated with depression. Each question has a value between 0-3 points, in terms of intensity. The questionnaire assesses cognitive, affective and neurovegetative depressive symptoms, with total score range from 0 to 63.
Measured: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
Central sensitization
Central sensitization was measured with Spanish version of Central Sensitization Inventory. This inventory tries to identify the presence of central sensitization. Part A of the questionnaire assess 25 health-related symptoms that are common to central sensitization, with total score ranging from 0 to 100. Part B (not scored) asks about specific disorders or pathologies associated with central sensitization.
Measured: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
Disability
Disability was measured with Spanish version of Oswestry Disability Index. This tool assess pain-related disability in people with low back pain. This index assess 1 item on pain and 9 items on activities of daily living (personal care, lifting, walking…). Scores ranges from 0 (no disability) to 100 (maximum disability).
Measured: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study startSep 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- 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
- Model description
- Parallel assignment. Randomized, longitudinal, experimental, prospective, parallel and double-blind study with chronic low back pain adults.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Oliver Martínez Pozas, PhD candidate, Principal investigator, Universidad Rey Juan Carlos (Madrid)Eleuterio A. Sánchez Romero, PhD, Study director, Universidad Europea de Madrid (Madrid)Josué Fernández Carnero, PhD, Study director, Universidad Rey Juan Carlos (Madrid)Héctor Beltrán Alacreu, PhD, Study director, Universidad de Castilla La-Mancha (Toledo)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940715
- Sponsor's protocol ID
- 1003202108421
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
den Bandt HL, Paulis WD, Beckwee D, Ickmans K, Nijs J, Voogt L. Pain Mechanisms in Low Back Pain: A Systematic Review With Meta-analysis of Mechanical Quantitative Sensory Testing Outcomes in People With Nonspecific Low Back Pain. J Orthop Sports Phys Ther. 2019 Oct;49(10):698-715. doi: 10.2519/jospt.2019.8876. Epub 2019 Aug 23.
PubMed 31443625Neelapala YVR, Bhagat M, Frey-Law L. Conditioned Pain Modulation in Chronic Low Back Pain: A Systematic Review of Literature. Clin J Pain. 2020 Feb;36(2):135-141. doi: 10.1097/AJP.0000000000000778.
PubMed 31764164McPhee ME, Vaegter HB, Graven-Nielsen T. Alterations in pronociceptive and antinociceptive mechanisms in patients with low back pain: a systematic review with meta-analysis. Pain. 2020 Mar;161(3):464-475. doi: 10.1097/j.pain.0000000000001737.
PubMed 32049888Alkhawajah HA, Alshami AM. The effect of mobilization with movement on pain and function in patients with knee osteoarthritis: a randomized double-blind controlled trial. BMC Musculoskelet Disord. 2019 Oct 18;20(1):452. doi: 10.1186/s12891-019-2841-4.
PubMed 31627723Lascurain-Aguirrebena I, Newham D, Critchley DJ. Mechanism of Action of Spinal Mobilizations: A Systematic Review. Spine (Phila Pa 1976). 2016 Jan;41(2):159-72. doi: 10.1097/BRS.0000000000001151.
PubMed 26751060Aspinall SL, Jacques A, Leboeuf-Yde C, Etherington SJ, Walker BF. No difference in pressure pain threshold and temporal summation after lumbar spinal manipulation compared to sham: A randomised controlled trial in adults with low back pain. Musculoskelet Sci Pract. 2019 Oct;43:18-25. doi: 10.1016/j.msksp.2019.05.011. Epub 2019 May 31.
PubMed 31176287Arribas-Romano A, Fernandez-Carnero J, Molina-Rueda F, Angulo-Diaz-Parreno S, Navarro-Santana MJ. Efficacy of Physical Therapy on Nociceptive Pain Processing Alterations in Patients with Chronic Musculoskeletal Pain: A Systematic Review and Meta-analysis. Pain Med. 2020 Oct 1;21(10):2502-2517. doi: 10.1093/pm/pnz366.
PubMed 32100027
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain: a Double-blinded, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04940715
- Acronym / sponsor ID
- 1003202108421
- Conditions
- Chronic Low-back Pain
- Keywords
- Chronic low back pain, Pain processing, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 25 Jun 2021 (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.
Patients with chronic low back pain may have altered pain processing, making them vulnerable to pain or disability. It can be measured with test like pressure pain threshold, temporal summation or conditioned pain modulation. Manual therapy has shown improve this pain processing variables in other conditions (like knee osteoarthritis or lateral elbow pain), although the quality of the evidence is low in terms of temporal summation and controversial in terms of conditioned pain modulation. There are not studies that had investigated the impact of manual therapy techniques on pain processing in patients with chronic low back pain.
Detailed description
Study Aims:
Aim #1: The main objective of this study is to determine the efficacy of two manual therapy approaches (passive joint mobilization and mobilization with movement) on pain (measured with Visual Analogue Scale) and pain processing (measured with pressure pain threshold, temporal summation and conditioned pain modulation) in patients with chronic low back pain and see its results on short, medium and long term.
Aim #2: The secondary objective is to compare the effect of both manual therapy techniques with an inactive control group in terms of pain and pain processing.
Aim #3: Determine the efficacy of manual therapy on intervention groups on psychological outcomes as catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale of Kinesiophobia) and depression (Beck Depressive Inventory) and compare them with control group.
Methodology Research Design: Randomized, longitudinal, experimental, prospective, parallel and double-blind study with patients with chronic low back pain.
Participants: Adults between 18-65 years old residing Comunidad de Madrid, all of whom were recruited personally for the study. All patients will read the information sheet explaining what the study will consist, as well as the informed consent form, which they will sign voluntarily beforehand.
Sample Size: The sample size will be calculated by means of the "Gpower 3.0.18" computer program.
Randomization: Randomization will be done through the GraphPad software (GraphPad Software, Inc CA 92037 USA). Patients who meet the inclusion criteria and have none of the exclusion criteria will be entered into the study and the sample will be randomized to obtain three groups in opaque and sealed envelopes: A (passive joint mobilization), B (mobilization with movement) and C (control group).
Masking: The double-blind criteria are met, in which the subjects participating in the study will not know the group to which they were assigned, as well as the physiotherapist in charge of collecting the outcomes data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel assignment. Randomized, longitudinal, experimental, prospective, parallel and double-blind study with chronic low back pain adults.
| Arm | Type | Receives |
|---|---|---|
| Passive joint mobilization | Experimental | Other: Passive joint mobilizationPatients lay down on a prone position, with their hands around the body and neck placed comfortable. The therapist performed a postero-anterior joint mobilization using Maitland's technique, applying pressure to spinous process of targeted vertebra (the one who reproduces patient's symptoms). |
| Mobilization with movement | Experimental | Other: Mobilization with movementPatients perform their painful movement (flexion, extension…). If pain wasn't reproduced, a combination of movements will be performed (flexion + rotation…). The most painful vertebral level was assessed too with passive accessory vertebral movements. Afterwards, with the patient on a seated position on a stretcher with feet supported and a belt around the waist, the therapist performed a sustained glide on the targeted vertebra (spinous process) with the force and direction that relieved pain to the lowest level. |
| Control group | No intervention | –Patients were measured at baseline and then were placed on "wait list" until the end of the study. At this time, they were measured again. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-specific chronic low back pain patients, without lower limb pain
- Pain lasting 6 months or more
- Pain measure of 2 or more on a 0 to 10 scale
- Age between 18-65 years old
- Haven't received physical therapy during last month
Key exclusion criteria (11 listed)
- Radiculopathy
- Neurological signs, symptoms or deficit
- Rheumatic/autoimmune/systemic disease
- History of fracture, trauma or previous spinal surgery
- Pregnancy
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 |
|---|---|---|
| Passive joint mobilizationDosage: 5 sets of 2 minutes with 30 seconds of rest were applied, with a strong force (>50% of maximum therapist strength), according to patient's irritability and severity. | Other | Passive joint mobilization |
| Mobilization with movementDosage: 3 sets of 10 repetitions were performed, with 1-2 minutes of rest between sets. | Other | Mobilization with movement |
Primary outcome
Pain
Time frame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
Visual Analogue Scale (VAS) was used to measure pain. It consists of a 100mm length line and has written "no pain" and "worst pain imaginable" on its ends and measures pain intensity. The confidence and reliability of this scale has been approved and validated in different studies.
Pressure pain threshold
Time frame: Time Frame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
A digital algometer was used to measure mechanical hyperalgesia. The model was de X® brand, consisting of a 1cm2 cylindrical rubber attached to a pressure gauge, calibrated in kilograms (kg). The scale expressed in kg/cm2 was used. Before the measurement, patients were trained in forearm muscles through a trial session. They were instructed to say STOP when the pressure sensation was painful. For the measurement, patients lay down on prone position on the stretcher and the algometer was placed perpendicular to skin on the measured points, who were marked prior to measurement (2cm lateral to L5 spinous process, C2 spinous process, ipsilateral anterior tibialis and contralateral epicondyle). A rest period of 30 seconds was established between the measurements. For each point, three measurements were done and their mean was calculated and recorded for analysis. The minimum detectable change (CMD) for considering the results as clinically relevant was established at 15% minimum.
Temporal summation
Time frame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
Temporal summation was measured with Von Frey monofilaments. Patients lay down on prone position and measurements were taken 1cm lateral to spinous process of L4. First, a single stimulus was applied and the patient assessed the pain intensity on a 0-10 numeric rating scale. After that, 10 rhythmic stimuli were applied on the same spot (1 stimuli per second) and the patient assessed again the pain intensity. The temporal summation effect was calculated as the difference between the mean rating of the three repetitions of one stimulus and the mean rating of the three repetitions of 10 stimulus.
Conditioned pain modulation
Time frame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.
Conditioned pain modulation was measured with tourniquet test. A sphygmomanometer was used to induce ischemic muscle pain as conditioning stimulus (model X®). It was applied around the contralateral upper arm, 3cm proximal to cubital fossa. Now, pressure pain threshold 2cm lateral to L5 spinous process was measured. Afterwards, the cuff was inflated to 260mmHg and maintained until the patient perceived a pain intensity of 6 on a 0-10 numeric rating pain scale. Then, the pressure pain threshold was measured again at the same spot during the conditioning stimulus and then the cuff pressure was released. The conditioned pain modulation value is the result of the subtraction of the value of the PPT during the conditioning stimulus minus the PPT without it.
5 secondary outcomes
Pain Catastrophizing
Time frame: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
Kinesiophobia
Time frame: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
Depression
Time frame: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
Central sensitization
Time frame: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
Disability
Time frame: Changes from baseline, after the last intervention and at both follow-up periods (1 month and 3 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Background: PubMed 31443625den Bandt HL, Paulis WD, Beckwee D, Ickmans K, Nijs J, Voogt L. Pain Mechanisms in Low Back Pain: A Systematic Review With Meta-analysis of Mechanical Quantitative Sensory Testing Outcomes in People With Nonspecific Low Back Pain. J Orthop Sports Phys Ther. 2019 Oct;49(10):698-715. doi: 10.2519/jospt.2019.8876. Epub 2019 Aug 23.
- Background: PubMed 31764164Neelapala YVR, Bhagat M, Frey-Law L. Conditioned Pain Modulation in Chronic Low Back Pain: A Systematic Review of Literature. Clin J Pain. 2020 Feb;36(2):135-141. doi: 10.1097/AJP.0000000000000778.
- Background: PubMed 32049888McPhee ME, Vaegter HB, Graven-Nielsen T. Alterations in pronociceptive and antinociceptive mechanisms in patients with low back pain: a systematic review with meta-analysis. Pain. 2020 Mar;161(3):464-475. doi: 10.1097/j.pain.0000000000001737.
- Background: PubMed 31627723Alkhawajah HA, Alshami AM. The effect of mobilization with movement on pain and function in patients with knee osteoarthritis: a randomized double-blind controlled trial. BMC Musculoskelet Disord. 2019 Oct 18;20(1):452. doi: 10.1186/s12891-019-2841-4.
- Background: PubMed 26751060Lascurain-Aguirrebena I, Newham D, Critchley DJ. Mechanism of Action of Spinal Mobilizations: A Systematic Review. Spine (Phila Pa 1976). 2016 Jan;41(2):159-72. doi: 10.1097/BRS.0000000000001151.
- Background: PubMed 31176287Aspinall SL, Jacques A, Leboeuf-Yde C, Etherington SJ, Walker BF. No difference in pressure pain threshold and temporal summation after lumbar spinal manipulation compared to sham: A randomised controlled trial in adults with low back pain. Musculoskelet Sci Pract. 2019 Oct;43:18-25. doi: 10.1016/j.msksp.2019.05.011. Epub 2019 May 31.
- Background: PubMed 32100027Arribas-Romano A, Fernandez-Carnero J, Molina-Rueda F, Angulo-Diaz-Parreno S, Navarro-Santana MJ. Efficacy of Physical Therapy on Nociceptive Pain Processing Alterations in Patients with Chronic Musculoskeletal Pain: A Systematic Review and Meta-analysis. Pain Med. 2020 Oct 1;21(10):2502-2517. doi: 10.1093/pm/pnz366.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Oliver Martínez Pozas, PhD candidate principal investigator
Universidad Rey Juan Carlos (Madrid)
Eleuterio A. Sánchez Romero, PhD study director
Universidad Europea de Madrid (Madrid)
Josué Fernández Carnero, PhD study director
Universidad Rey Juan Carlos (Madrid)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive joint mobilization and Mobilization with movement in people with Chronic Low-back Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 25 Jun 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josué Fernández, PhD (+34 91 488 89 49, josue.fernandez@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Change from baseline, after the first intervention, after the last intervention and at both follow-up (1 month and 3 months) periods.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04940715, which also lists 7 linked publications.
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 25 Jun 2021.