Low Back PainNCT06330961
Effects of Different Kinds of Exercise in Low Back Pain
A study testing Isometric exercise and Aerobic exercise in people with Low Back Pain, run by University of Valencia at 1 site in Spain.
Trial summary
Low back pain is considered one of the great global challenges in public health due to its high prevalence. Exercise have been shown to cause an increase in pain thresholds, through the effect known as exercise-induced hypoalgesia. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Isometric exercise and Aerobic exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2024to 13 May 2025
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Control group: no prior history of low back pain or any other kind of low back disorders.
- Low back pain group:
- current symptoms of non-specific low back pain
- Symptoms must be severe enough to have caused recent loss of work days.
Who cannot join
- mental or cognitive impairment influencing the ability to understand and execute oral or written instructions
- any sign or symptom suggestive of potential underlying diseases
- presence of red flags or high-risk criteria for referral to emergency medical services
- severe functional limitation due to the intensity of the pain
- high irritability of symptoms at the time of the selection process
- inability to tolerate the prone position
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinical Anatomy of the Musculoskeletal System Laboratory. Department of Anatomy and Human Embryology, School of Medicine, Universitat de València
Valencia, Valencia, 46010
About this study
Official title: Effects of Different Kinds of Exercises in Pain, Lumbopelvic Biomechanics and Pain Pressure Thresholds in Patients With Non-specific Low Back Pain
Low back pain is considered one of the great global challenges in public health due to its high prevalence. Exercise have been shown to cause an increase in pain thresholds, through the effect known as exercise-induced hypoalgesia. Little is known about exercise-induced hypoalgesia induced by different modalities of exercise in low back pain, and its possible effects in lumbopelvic biomechanics.
The goal of this clinical trial is to compare the effect of exercise-induced hypoalgesia after an isometric, aerobic and a sham/ placebo exercise in non-specific low back pain. The main questions it aims to answer are:
Read more
- Does an isometric exercise intervention cause exercise-induced hypoalgesia in non-specific low back pain patients?
- Is the effect of an isometric exercise intervention comparable to that of aerobic exercise?
- Is a placebo/ sham intervention also effective to reduce pain thresholds in these patients?
- Do healthy subjects show the same effects in pain thresholds as low back pain patients ? Participants will perform an isometric, aerobic and placebo/ sham exercise intervention in three different recording sessions. Before and after the interventions, pain intensity, pain-pressure thresholds and lumbopelvic biomechanical parameters during trunk flexion-extension will be recorded.
Researchers will compare a group of low back pain patients to an age-, gender- and anthropometrics-matched control group of pain-free subjects to see if exercise-induced hypoalgesia is also observed when there is no low back pain diagnosis.
Read the detailed description
Exercise causes an immediate reduction in pain sensitivity, known as exercise-induced hypoalgesia. This phenomenon is described as the immediate and lasting reduction of pain sensitivity after therapeutic exercise. This effect has been observed after isometric muscle contractions and aerobic exercises in healthy subjects.
The hypoalgesic response is often shown as an increase in pain-pressure thresholds in regions close to the most active muscle groups during exercise, and also in regions further away, which probably reflects the activation of systemic endogenous pain inhibitory systems. This effect has also been studied in patients with chronic pain.
Although there is previous work that has shown that aerobic exercise and isometric exercise can cause exercise-induced hypoalgesia, there is no evidence on exercise-induced hypoalgesia caused by isometric maneuvers in patients with low back pain. There is also a lack of placebo-controlled studies, or even studies comparing the analgesic effect of isometric and aerobic exercise in this population.
Therefore, the aim of this study will be to investigate, in a placebo-controlled intervention, whether various exercise modalities (isometric, aerobic) that involve activation of the lumbopelvic muscles result in local hypoalgesia in the area of the most active muscles, and/or hypoalgesia in more distant areas of the body, in subjects with low back pain and a group of healthy subjects which will serve as a control group.
- Conditions
- Low Back Pain
- Being tested
- Isometric exercise, Aerobic exercise, Placebo intervention
- Keywords
- low back pain, isometric exercise, pain threshold, back muscles, surface electromyography
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exerciseOther
Biering-Sorensen maneuver.Participants will be in a prone position with the anterosuperior iliac spines on the edge of a stretcher. Their lower body will be strapped by the ankles and hips, with the upper body suspended. Participants will keep their trunk extended and parallel to the ground for 60 seconds.
Aerobic exerciseOther
After adjusting height, pedals and backrest in a cycloergometer, there will be 20 minutes of cycling, of which 5 minutes will be a warm-up at 50-60% of maximum heart rate and 15 minutes at 60-70% of maximum heart rate. There will be a constant monitoring of heart rate and oxygen saturation.
Placebo interventionOther
A maneuver equivalent to Biering-Sorensen test, but with upper limb support on a level step and electromyographic monitoring to ensure minimal activation of the erector spinae. It will be explained to the participant that the aim of such an intervention is to cause electromyographic silence of the erector spinae and keep it for 1 minute.
| Study group | Role | What they receive |
|---|---|---|
| Pain-free participants | Experimental | Aerobic exercise, Biering-Sorensen test and placebo interventions will be administered to a group of subjects with no past history of low back pain. They will serve as a control group. Receives: Other: Isometric exercise; Other: Aerobic exercise; Other: Placebo intervention |
| Low back pain patients | Experimental | Aerobic exercise, Biering-Sorensen test and placebo interventions will be administered to a group of non-specific low back pain patients. They will serve as the primary intervention group. Receives: Other: Isometric exercise; Other: Aerobic exercise; Other: Placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be tested using a visual analogue scale, scored from 0 to 10.
Measured: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Pain-pressure thresholds
Pain-pressure thresholds will be measured with an algometer on 3 points in a randomized order: 1) thenar eminence; 2) erector spinae (5 cm distal to L3); 3) the center of the long head of biceps femoris. Unit: kg/cm2
Measured: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Trunk flexion-extension electromyography (EMG)
Average percentages of lumbopelvic muscles activation during flexion, extension, eccentric and concentric contractions and the myoelectrical silence, recorded by an EMG100C Biopac module (Biopac Systems, Inc., Goleta, CA). Unit: percentages of maximum muscle activation
Measured: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Flexion-extension ratio (EMG)
A ratio between the average lumbopelvic muscles activity at trunk flexion and its average activity at extension, to quantify the relaxation level of the muscle. Unit: dimensionless
Measured: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Maximum ranges of lumbar and pelvic flexion
Maximum ranges of lumbar and pelvic flexion, in degrees, measured with a Liberty 240/16 electrogoniometer (Polhemus Inc., Colchester, USA). Unit: degrees
Measured: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Trunk flexion-extension percentages of motion
Average percentages of maximum lumbar and pelvic flexion during flexion and extension, and at the start and end of lumbopelvic muscles relaxation, measured with a Liberty 240/16 electrogoniometer (Polhemus Inc., Colchester, USA) and expressed as a percentage of the maximum range of flexion during each flexion-extension cycle. Unit: percentages of maximum flexion
Measured: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Time of maximum flexion
Percentage of total flexion-extension time during which the lumbar spine and the pelvis are flexed over 90% of their maximum flexion, measured with a Liberty 240/16 electrogoniometer (Polhemus Inc., Colchester, USA). Unit: percentage of total flexion-extension time
Measured: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Fear-avoidance beliefs
Fear-avoidance beliefs will be tested using a validated version of the Fear-Avoidance Beliefs Questionnaire (FABQ).
Measured: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Pain distribution and supra-threshold stimulation
Area of pain irradiation, and area of distribution of pressure-induced referred pain after a supra-threshold stimulation over the infraspinatus muscle. Depicted by the participants on a body chart. Unit: cm2
Measured: Day 1, before and after the first intervention. Day 8, before and after the second intervention. Day 15, before and after the third intervention.
Secondary outcomes (5)
Anthropometric data: height
Measured with a stadiometer, barefoot. Unit: meters
Measured: Day 1, before the first intervention. Day 8, before the second intervention. Day 15, before the third intervention.
Anthropometric data: weight
Measured with a calibrated scale with the participant barefoot and wearing light clothes. Unit: kilograms
Measured: Day 1, before the first intervention. Day 8, before the second intervention. Day 15, before the third intervention.
Date of birth/ age
Self-reported. Unit: years
Measured: Day 1, before the first intervention.
Sex/ gender
Self-reported
Measured: Day 1, before the first intervention.
Basic clinical history and occupational data
Self-reported, in an interview. Antecedents of low back pain, occupation
Measured: Day 1, before the first intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start8 Jan 2024
- Primary completion13 May 2025
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Sánchez-Zuriaga, University of Valencia
- Investigators
- Daniel Sánchez-Zuriaga, PhD, MD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330961
- Sponsor's protocol ID
- 2023-MED-2756299
- Status last verified
- May 2025
- First submitted
- 31 Jan 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Kinds of Exercises in Pain, Lumbopelvic Biomechanics and Pain Pressure Thresholds in Patients With Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06330961
- Acronym / sponsor ID
- 2023-MED-2756299
- Conditions
- Low Back Pain
- Keywords
- low back pain, isometric exercise, pain threshold, back muscles, surface electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 26 Mar 2024 (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 considered one of the great global challenges in public health due to its high prevalence. Exercise have been shown to cause an increase in pain thresholds, through the effect known as exercise-induced hypoalgesia. Little is known about exercise-induced hypoalgesia induced by different modalities of exercise in low back pain, and its possible effects in lumbopelvic biomechanics.
The goal of this clinical trial is to compare the effect of exercise-induced hypoalgesia after an isometric, aerobic and a sham/ placebo exercise in non-specific low back pain. The main questions it aims to answer are:
- Does an isometric exercise intervention cause exercise-induced hypoalgesia in non-specific low back pain patients?
- Is the effect of an isometric exercise intervention comparable to that of aerobic exercise?
- Is a placebo/ sham intervention also effective to reduce pain thresholds in these patients?
- Do healthy subjects show the same effects in pain thresholds as low back pain patients ? Participants will perform an isometric, aerobic and placebo/ sham exercise intervention in three different recording sessions. Before and after the interventions, pain intensity, pain-pressure thresholds and lumbopelvic biomechanical parameters during trunk flexion-extension will be recorded.
Researchers will compare a group of low back pain patients to an age-, gender- and anthropometrics-matched control group of pain-free subjects to see if exercise-induced hypoalgesia is also observed when there is no low back pain diagnosis.
Detailed description
Exercise causes an immediate reduction in pain sensitivity, known as exercise-induced hypoalgesia. This phenomenon is described as the immediate and lasting reduction of pain sensitivity after therapeutic exercise. This effect has been observed after isometric muscle contractions and aerobic exercises in healthy subjects.
The hypoalgesic response is often shown as an increase in pain-pressure thresholds in regions close to the most active muscle groups during exercise, and also in regions further away, which probably reflects the activation of systemic endogenous pain inhibitory systems. This effect has also been studied in patients with chronic pain.
Although there is previous work that has shown that aerobic exercise and isometric exercise can cause exercise-induced hypoalgesia, there is no evidence on exercise-induced hypoalgesia caused by isometric maneuvers in patients with low back pain. There is also a lack of placebo-controlled studies, or even studies comparing the analgesic effect of isometric and aerobic exercise in this population.
Therefore, the aim of this study will be to investigate, in a placebo-controlled intervention, whether various exercise modalities (isometric, aerobic) that involve activation of the lumbopelvic muscles result in local hypoalgesia in the area of the most active muscles, and/or hypoalgesia in more distant areas of the body, in subjects with low back pain and a group of healthy subjects which will serve as a control group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain-free participants | Experimental | Other: Isometric exercise, Other: Aerobic exercise, Other: Placebo interventionAerobic exercise, Biering-Sorensen test and placebo interventions will be administered to a group of subjects with no past history of low back pain. They will serve as a control group. |
| Low back pain patients | Experimental | Other: Isometric exercise, Other: Aerobic exercise, Other: Placebo interventionAerobic exercise, Biering-Sorensen test and placebo interventions will be administered to a group of non-specific low back pain patients. They will serve as the primary intervention group. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Control group: no prior history of low back pain or any other kind of low back disorders.
- current symptoms of non-specific low back pain
- Symptoms must be severe enough to have caused recent loss of work days.
Key exclusion criteria (6 listed)
- mental or cognitive impairment influencing the ability to understand and execute oral or written instructions
- any sign or symptom suggestive of potential underlying diseases
- presence of red flags or high-risk criteria for referral to emergency medical services
- severe functional limitation due to the intensity of the pain
- high irritability of symptoms at the time of the selection process
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 |
|---|---|---|
| Isometric exerciseBiering-Sorensen maneuver.Participants will be in a prone position with the anterosuperior iliac spines on the edge of a stretcher. Their lower body will be strapped by the ankles and hips, with the upper body suspended. Participants will keep their trunk extended and parallel to the ground for 60 seconds. | Other | Low back pain patients, Pain-free participants |
| Aerobic exerciseAfter adjusting height, pedals and backrest in a cycloergometer, there will be 20 minutes of cycling, of which 5 minutes will be a warm-up at 50-60% of maximum heart rate and 15 minutes at 60-70% of maximum heart rate. There will be a constant monitoring of heart rate and oxygen saturation. | Other | Low back pain patients, Pain-free participants |
| Placebo interventionA maneuver equivalent to Biering-Sorensen test, but with upper limb support on a level step and electromyographic monitoring to ensure minimal activation of the erector spinae. It will be explained to the participant that the aim of such an intervention is to cause electromyographic silence of the erector spinae and keep it for 1 minute. | Other | Low back pain patients, Pain-free participants |
Primary outcome
Pain intensity
Time frame: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Pain intensity will be tested using a visual analogue scale, scored from 0 to 10.
Pain-pressure thresholds
Time frame: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Pain-pressure thresholds will be measured with an algometer on 3 points in a randomized order: 1) thenar eminence; 2) erector spinae (5 cm distal to L3); 3) the center of the long head of biceps femoris. Unit: kg/cm2
Trunk flexion-extension electromyography (EMG)
Time frame: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Average percentages of lumbopelvic muscles activation during flexion, extension, eccentric and concentric contractions and the myoelectrical silence, recorded by an EMG100C Biopac module (Biopac Systems, Inc., Goleta, CA). Unit: percentages of maximum muscle activation
Flexion-extension ratio (EMG)
Time frame: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
A ratio between the average lumbopelvic muscles activity at trunk flexion and its average activity at extension, to quantify the relaxation level of the muscle. Unit: dimensionless
Maximum ranges of lumbar and pelvic flexion
Time frame: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Maximum ranges of lumbar and pelvic flexion, in degrees, measured with a Liberty 240/16 electrogoniometer (Polhemus Inc., Colchester, USA). Unit: degrees
Trunk flexion-extension percentages of motion
Time frame: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Average percentages of maximum lumbar and pelvic flexion during flexion and extension, and at the start and end of lumbopelvic muscles relaxation, measured with a Liberty 240/16 electrogoniometer (Polhemus Inc., Colchester, USA) and expressed as a percentage of the maximum range of flexion during each flexion-extension cycle. Unit: percentages of maximum flexion
Time of maximum flexion
Time frame: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Percentage of total flexion-extension time during which the lumbar spine and the pelvis are flexed over 90% of their maximum flexion, measured with a Liberty 240/16 electrogoniometer (Polhemus Inc., Colchester, USA). Unit: percentage of total flexion-extension time
Fear-avoidance beliefs
Time frame: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.
Fear-avoidance beliefs will be tested using a validated version of the Fear-Avoidance Beliefs Questionnaire (FABQ).
Pain distribution and supra-threshold stimulation
Time frame: Day 1, before and after the first intervention. Day 8, before and after the second intervention. Day 15, before and after the third intervention.
Area of pain irradiation, and area of distribution of pressure-induced referred pain after a supra-threshold stimulation over the infraspinatus muscle. Depicted by the participants on a body chart. Unit: cm2
5 secondary outcomes
Anthropometric data: height
Time frame: Day 1, before the first intervention. Day 8, before the second intervention. Day 15, before the third intervention.
Anthropometric data: weight
Time frame: Day 1, before the first intervention. Day 8, before the second intervention. Day 15, before the third intervention.
Date of birth/ age
Time frame: Day 1, before the first intervention.
Sex/ gender
Time frame: Day 1, before the first intervention.
Basic clinical history and occupational data
Time frame: Day 1, before the first intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Daniel Sánchez-Zuriaga, PhD, MD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercise and Aerobic exercise in people with Low Back Pain, run by University of Valencia 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 18 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.). The study lists 9 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 18 May 2025.