Mechanical Low Back PainCLT-LBP-RUNNCT07604168
Effect of Coordinated Locomotor Training on Lumbopelvic Stability and Pain in Runners With Mechanical Low Back Pain
A study testing Coordinated Locomotor Training and Plyometric Training in people with Mechanical Low Back Pain and Lumbopelvic Pain, run by University of Faisalabad at 1 site in Pakistan.
Trial summary
Mechanical low back pain is a common problem among novice runners, often caused by poor control of the lumbopelvic region and weak core stability. Coordinated Locomotor Training is a neuromotor exercise approach that improves the coordination of arm and leg movements while activating trunk muscles. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Mechanical Low Back Pain, Lumbopelvic Pain
- What is being tested?
- Coordinated Locomotor Training and Plyometric Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 24 Apr 2026
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 30 years
- Novice runner with less than one year of consistent running experience
- History of mechanical low back pain for 6 to 12 weeks (sub-acute phase)
- Pain intensity between 4 and 6 on the Numeric Pain Rating Scale
- Running frequency of 2 to 4 sessions per week with total weekly mileage less than 25 km
- Pain aggravated by mechanical activities (running, lifting, prolonged standing) and relieved by rest
- Willingness to participate and provide written informed consent
Who cannot join
- Participation in any structured core training or rehabilitation program within the past 3 months
- History of spinal surgery or specific spinal pathology (disc herniation, spondylolisthesis)
- Presence of pain radiating below the knee or neurological symptoms (numbness, tingling, weakness)
- Current lower limb injury affecting running performance
- Severe pain intensity greater than 6 on the Numeric Pain Rating Scale
- Pregnancy or postpartum period within the last 6 months in females
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The University of Faisalabad
Faisalābad, Punjab Province, 3800
About this study
Official title: Effect of Coordinated Locomotor Training on Lumbopelvic Stability and Pain Limitations in Runners With Mechanical Low Back Pain: A Randomized Controlled Trial
Mechanical low back pain is a common problem among novice runners, often caused by poor control of the lumbopelvic region and weak core stability. Coordinated Locomotor Training is a neuromotor exercise approach that improves the coordination of arm and leg movements while activating trunk muscles. This study aims to determine whether Coordinated Locomotor Training improves lumbopelvic stability and reduces pain-related limitations in runners with mechanical low back pain compared to plyometric training. The study is a randomized controlled trial that will enroll 28 novice runners from universities in Faisalabad, Pakistan. Participants will be randomly assigned to one of two groups. One group will receive Coordinated Locomotor Training for 60 minutes per session, twice weekly, for 8 weeks. The other group will receive plyometric training for the same duration and frequency. Lumbopelvic stability will be measured using a pelvic inclinometer and a flexible ruler. Pain levels will be measured using the Numeric Pain Rating Scale. Measurements will be taken before and after the 8-week intervention period. The investigators hypothesize that Coordinated Locomotor Training will lead to greater improvements in lumbopelvic stability and greater reductions in pain compared to plyometric training.
Read the detailed description
Background: Mechanical low back pain is one of the most common musculoskeletal conditions affecting individuals globally. Lumbopelvic instability is linked to persistent pain and dysfunction in individuals with low back pain. During running, an anterior pelvic tilt is associated with an increased degree of lumbar lordosis, creating mechanical stress from repetitive loading. This stress can lead to running-related low back pain and other overuse symptoms. Novice runners are particularly vulnerable due to poor lumbopelvic control, altered biomechanics, and weak core stability.
Coordinated Locomotor Training is a neuromotor exercise approach designed to enhance synchronization of upper and lower limb movements while promoting activation of trunk and abdominal musculature. By stimulating contraction of abdominal muscles through upper and lower extremity motions in various postures, Coordinated Locomotor Training has been shown to improve postural control. However, there is limited research on the use of Coordinated Locomotor Training in novice runners, particularly for improving lumbopelvic stability and reducing pain limitations.
Study Design: This is a randomized controlled trial with double blinding (participants and outcome assessors will be blinded to group assignment). The study will be conducted at three university settings in Faisalabad, Pakistan: The University of Faisalabad, Government College University of Faisalabad, and Agriculture University of Faisalabad.
Participant Screening: Potential participants will be screened against inclusion and exclusion criteria. Inclusion criteria include age 18 to 30 years, novice runner status (less than one year of consistent running experience), history of mechanical low back pain for 6 to 12 weeks (sub-acute phase), pain intensity between 4 and 6 on the Numeric Pain Rating Scale, running frequency of 2 to 4 sessions per week with total weekly mileage less than 25 kilometers, pain aggravated by mechanical activities such as running, lifting, and prolonged standing and relieved by rest, and willingness to provide written informed consent. Exclusion criteria include participation in any structured core training or rehabilitation program within the past 3 months, history of spinal surgery or specific spinal pathology such as disc herniation or spondylolisthesis, presence of pain radiating below the knee or neurological symptoms including numbness, tingling, or weakness, current lower limb injury affecting running performance, severe pain intensity greater than 6 on the Numeric Pain Rating Scale, pregnancy or postpartum period within the last 6 months, and unwillingness to participate.
Randomization: Participants will be randomly assigned to one of two groups using a computer-generated random sequence. Allocation concealment will be maintained using sealed opaque envelopes.
Group A Intervention (Coordinated Locomotor Training): Participants will perform a 5-minute warm-up to familiarize with sprinter and skater techniques actively performed in a standing position. The main Coordinated Locomotor Training session lasts 60 minutes, given twice per week for 8 weeks (16 total sessions). Participants will perform coordinated movement training in four positions: supine, crawling, sitting, and standing. In each position, participants perform 10 repetitions per set, completing 3 sets total for approximately 30 minutes of active training. The sprinter pattern involves alternating arm and leg movements mimicking running form. The skater pattern involves lateral weight shifts with coordinated arm and leg opposition.
Group B Intervention (Plyometric Training): The warm-up consists of two sets of 30-second stimulation sessions followed by a 30-second cool-down with multidirectional hops spaced up to five seconds apart. Participants then perform six series of squat jumps with 30 seconds of activation and 30 seconds of relaxation between series. Each jump uses a 45 cm box height, with a two-second gap between each jump within each series. Total session time is 60 minutes, twice per week for 8 weeks.
Outcome Measurements: All outcome measures will be assessed at baseline (week 0) and post-intervention (week 8). The primary outcome is pain, measured using the Numeric Pain Rating Scale, an 11-point scale from 0 (no pain) to 10 (worst possible pain). The secondary outcome is lumbopelvic stability, measured using two tools. First, a handmade pelvic inclinometer measures anterior pelvic tilt by placing caliper tips on the anterior superior iliac spine and posterior superior iliac spine of the ilium, then reading the angle from the protractor scale. Second, a flexible curve ruler measures lumbar lordosis by molding a flexible piece of lead to fit the spine from T12 to S2, tracing the shape onto paper, and calculating lordosis from the curvature length and maximum width.
Data Analysis: Data will be analyzed using SPSS version 22. Descriptive statistics will be calculated for baseline characteristics. Normality of data distribution will be assessed using the Shapiro-Wilk test. For normally distributed data, between-group comparisons will be performed using independent t-tests, and within-group comparisons will be performed using paired t-tests. For non-normally distributed data, Mann-Whitney U tests will be used for between-group comparisons and Wilcoxon signed-rank tests for within-group comparisons. Statistical significance will be set at p < 0.05.
Ethical Considerations: Ethical approval has been obtained from the Institutional Review Board of The University of Faisalabad. Written informed consent will be obtained from all participants prior to enrollment. Participants will be informed of their right to withdraw from the study at any time without penalty. Confidentiality of all participant data will be maintained. The study will be conducted in accordance with the Declaration of Helsinki.
- Conditions
- Mechanical Low Back Pain, Lumbopelvic Pain
- Being tested
- Coordinated Locomotor Training, Plyometric Training
- Keywords
- Coordinated Locomotor Training, Novice Runners, Core Stability, Neuromotor Training
- 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.
Coordinated Locomotor TrainingBehavioural
Coordinated Locomotor Training is a neuromotor exercise program that enhances synchronization of upper and lower limb movements while promoting trunk muscle activation. The protocol includes sprinter and skater pattern exercises performed in four positions: supine, crawling, sitting, and standing. Participants perform 10 repetitions per set, completing 3 sets per session. Each session includes a 5-minute warm-up followed by 30 minutes of active training, totaling 60 minutes per session. The intervention is delivered twice weekly for 8 weeks (16 sessions total) by a trained physical therapist.
Plyometric TrainingBehavioural
Plyometric training consists of explosive jump exercises designed to improve power and neuromuscular control. The protocol includes two sets of 30-second stimulation sessions with multidirectional hops, followed by six series of squat jumps using a 45 cm box height. Each series includes 30 seconds of activation and 30 seconds of relaxation, with a two-second gap between each jump. Total session time is 60 minutes, delivered twice weekly for 8 weeks (16 sessions total).
| Study group | Role | What they receive |
|---|---|---|
| Coordinated Locomotor Training Group | Experimental | Participants receive Coordinated Locomotor Training consisting of sprinter and skater pattern exercises performed in supine, crawling, sitting, and standing positions. Each session lasts 60 minutes, twice weekly for 8 weeks. Receives: Behavioral: Coordinated Locomotor Training |
| Plyometric Training Group | Active comparator | Participants receive plyometric training consisting of squat jumps and multidirectional hops using a 45 cm box. Each session lasts 60 minutes, twice weekly for 8 weeks. Receives: Behavioral: Plyometric Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Pain intensity will be measured using the Numeric Pain Rating Scale, an 11-point scale from 0 (no pain) to 10 (worst possible pain). Participants rate their current low back pain and their worst pain over the past 24 hours. The scale has excellent test-retest reliability (r > 0.90) and high sensitivity to clinical change.
Measured: Baseline (week 0) and post-intervention (week 8)
Secondary outcomes (2)
Change in Lumbopelvic Stability - Anterior Pelvic Tilt
Anterior pelvic tilt in degrees will be measured using a handmade pelvic inclinometer. The examiner places one caliper tip on the anterior superior iliac spine and the other tip on the posterior superior iliac spine of the same ilium. The angle in degrees is read from the protractor scale. A greater angle indicates increased anterior pelvic tilt.
Measured: Baseline (week 0) and post-intervention (week 8)
Change in Lumbopelvic Stability - Lumbar Lordosis Angle
Lumbar lordosis angle (°) will be measured using a flexible curve ruler. The ruler will be molded to fit the lumbar spine from T12 to S2, then removed and traced onto paper. The total length of the curvature (L, cm) and the maximum width or depth of the curvature (H, cm) will be measured. The lumbar lordosis angle will then be calculated and expressed in degrees (°) using the standard flexible ruler formula.
Measured: Baseline (week 0) and post-intervention (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jan 2026
- Primary completion19 Apr 2026
- Study completion24 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Muneeb Jafar, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604168
- Sponsor's protocol ID
- TUF/EIRB/ 209 /26
- Acronym
- CLT-LBP-RUN
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 8 Jun 2026
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coordinated Locomotor Training on Lumbopelvic Stability and Pain Limitations in Runners With Mechanical Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07604168
- Acronym / sponsor ID
- CLT-LBP-RUN / TUF/EIRB/ 209 /26
- Conditions
- Mechanical Low Back Pain, Lumbopelvic Pain
- Keywords
- Coordinated Locomotor Training, Novice Runners, Core Stability, Neuromotor Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 19 Apr 2026 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 22 May 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.
Mechanical low back pain is a common problem among novice runners, often caused by poor control of the lumbopelvic region and weak core stability. Coordinated Locomotor Training is a neuromotor exercise approach that improves the coordination of arm and leg movements while activating trunk muscles. This study aims to determine whether Coordinated Locomotor Training improves lumbopelvic stability and reduces pain-related limitations in runners with mechanical low back pain compared to plyometric training. The study is a randomized controlled trial that will enroll 28 novice runners from universities in Faisalabad, Pakistan. Participants will be randomly assigned to one of two groups. One group will receive Coordinated Locomotor Training for 60 minutes per session, twice weekly, for 8 weeks. The other group will receive plyometric training for the same duration and frequency. Lumbopelvic stability will be measured using a pelvic inclinometer and a flexible ruler. Pain levels will be measured using the Numeric Pain Rating Scale. Measurements will be taken before and after the 8-week intervention period. The investigators hypothesize that Coordinated Locomotor Training will lead to greater improvements in lumbopelvic stability and greater reductions in pain compared to plyometric training.
Detailed description
Background: Mechanical low back pain is one of the most common musculoskeletal conditions affecting individuals globally. Lumbopelvic instability is linked to persistent pain and dysfunction in individuals with low back pain. During running, an anterior pelvic tilt is associated with an increased degree of lumbar lordosis, creating mechanical stress from repetitive loading. This stress can lead to running-related low back pain and other overuse symptoms. Novice runners are particularly vulnerable due to poor lumbopelvic control, altered biomechanics, and weak core stability.
Coordinated Locomotor Training is a neuromotor exercise approach designed to enhance synchronization of upper and lower limb movements while promoting activation of trunk and abdominal musculature. By stimulating contraction of abdominal muscles through upper and lower extremity motions in various postures, Coordinated Locomotor Training has been shown to improve postural control. However, there is limited research on the use of Coordinated Locomotor Training in novice runners, particularly for improving lumbopelvic stability and reducing pain limitations.
Study Design: This is a randomized controlled trial with double blinding (participants and outcome assessors will be blinded to group assignment). The study will be conducted at three university settings in Faisalabad, Pakistan: The University of Faisalabad, Government College University of Faisalabad, and Agriculture University of Faisalabad.
Participant Screening: Potential participants will be screened against inclusion and exclusion criteria. Inclusion criteria include age 18 to 30 years, novice runner status (less than one year of consistent running experience), history of mechanical low back pain for 6 to 12 weeks (sub-acute phase), pain intensity between 4 and 6 on the Numeric Pain Rating Scale, running frequency of 2 to 4 sessions per week with total weekly mileage less than 25 kilometers, pain aggravated by mechanical activities such as running, lifting, and prolonged standing and relieved by rest, and willingness to provide written informed consent. Exclusion criteria include participation in any structured core training or rehabilitation program within the past 3 months, history of spinal surgery or specific spinal pathology such as disc herniation or spondylolisthesis, presence of pain radiating below the knee or neurological symptoms including numbness, tingling, or weakness, current lower limb injury affecting running performance, severe pain intensity greater than 6 on the Numeric Pain Rating Scale, pregnancy or postpartum period within the last 6 months, and unwillingness to participate.
Randomization: Participants will be randomly assigned to one of two groups using a computer-generated random sequence. Allocation concealment will be maintained using sealed opaque envelopes.
Group A Intervention (Coordinated Locomotor Training): Participants will perform a 5-minute warm-up to familiarize with sprinter and skater techniques actively performed in a standing position. The main Coordinated Locomotor Training session lasts 60 minutes, given twice per week for 8 weeks (16 total sessions). Participants will perform coordinated movement training in four positions: supine, crawling, sitting, and standing. In each position, participants perform 10 repetitions per set, completing 3 sets total for approximately 30 minutes of active training. The sprinter pattern involves alternating arm and leg movements mimicking running form. The skater pattern involves lateral weight shifts with coordinated arm and leg opposition.
Group B Intervention (Plyometric Training): The warm-up consists of two sets of 30-second stimulation sessions followed by a 30-second cool-down with multidirectional hops spaced up to five seconds apart. Participants then perform six series of squat jumps with 30 seconds of activation and 30 seconds of relaxation between series. Each jump uses a 45 cm box height, with a two-second gap between each jump within each series. Total session time is 60 minutes, twice per week for 8 weeks.
Outcome Measurements: All outcome measures will be assessed at baseline (week 0) and post-intervention (week 8). The primary outcome is pain, measured using the Numeric Pain Rating Scale, an 11-point scale from 0 (no pain) to 10 (worst possible pain). The secondary outcome is lumbopelvic stability, measured using two tools. First, a handmade pelvic inclinometer measures anterior pelvic tilt by placing caliper tips on the anterior superior iliac spine and posterior superior iliac spine of the ilium, then reading the angle from the protractor scale. Second, a flexible curve ruler measures lumbar lordosis by molding a flexible piece of lead to fit the spine from T12 to S2, tracing the shape onto paper, and calculating lordosis from the curvature length and maximum width.
Data Analysis: Data will be analyzed using SPSS version 22. Descriptive statistics will be calculated for baseline characteristics. Normality of data distribution will be assessed using the Shapiro-Wilk test. For normally distributed data, between-group comparisons will be performed using independent t-tests, and within-group comparisons will be performed using paired t-tests. For non-normally distributed data, Mann-Whitney U tests will be used for between-group comparisons and Wilcoxon signed-rank tests for within-group comparisons. Statistical significance will be set at p < 0.05.
Ethical Considerations: Ethical approval has been obtained from the Institutional Review Board of The University of Faisalabad. Written informed consent will be obtained from all participants prior to enrollment. Participants will be informed of their right to withdraw from the study at any time without penalty. Confidentiality of all participant data will be maintained. The study will be conducted in accordance with the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coordinated Locomotor Training Group | Experimental | Behavioral: Coordinated Locomotor TrainingParticipants receive Coordinated Locomotor Training consisting of sprinter and skater pattern exercises performed in supine, crawling, sitting, and standing positions. Each session lasts 60 minutes, twice weekly for 8 weeks. |
| Plyometric Training Group | Active comparator | Behavioral: Plyometric TrainingParticipants receive plyometric training consisting of squat jumps and multidirectional hops using a 45 cm box. Each session lasts 60 minutes, twice weekly for 8 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18 and 30 years
- Novice runner with less than one year of consistent running experience
- History of mechanical low back pain for 6 to 12 weeks (sub-acute phase)
- Pain intensity between 4 and 6 on the Numeric Pain Rating Scale
- Running frequency of 2 to 4 sessions per week with total weekly mileage less than 25 km
Key exclusion criteria (6 listed)
- Participation in any structured core training or rehabilitation program within the past 3 months
- History of spinal surgery or specific spinal pathology (disc herniation, spondylolisthesis)
- Presence of pain radiating below the knee or neurological symptoms (numbness, tingling, weakness)
- Current lower limb injury affecting running performance
- Severe pain intensity greater than 6 on the Numeric Pain Rating Scale
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 |
|---|---|---|
| Coordinated Locomotor TrainingCoordinated Locomotor Training is a neuromotor exercise program that enhances synchronization of upper and lower limb movements while promoting trunk muscle activation. The protocol includes sprinter and skater pattern exercises performed in four positions: supine, crawling, sitting, and standing. Participants perform 10 repetitions per set, completing 3 sets per session. Each session includes a 5-minute warm-up followed by 30 minutes of active training, totaling 60 minutes per session. The intervention is delivered twice weekly for 8 weeks (16 sessions total) by a trained physical therapist. | Behavioural | Coordinated Locomotor Training Group |
| Plyometric TrainingPlyometric training consists of explosive jump exercises designed to improve power and neuromuscular control. The protocol includes two sets of 30-second stimulation sessions with multidirectional hops, followed by six series of squat jumps using a 45 cm box height. Each series includes 30 seconds of activation and 30 seconds of relaxation, with a two-second gap between each jump. Total session time is 60 minutes, delivered twice weekly for 8 weeks (16 sessions total). | Behavioural | Plyometric Training Group |
Primary outcome
Change in Pain Intensity
Time frame: Baseline (week 0) and post-intervention (week 8)
Pain intensity will be measured using the Numeric Pain Rating Scale, an 11-point scale from 0 (no pain) to 10 (worst possible pain). Participants rate their current low back pain and their worst pain over the past 24 hours. The scale has excellent test-retest reliability (r > 0.90) and high sensitivity to clinical change.
2 secondary outcomes
Change in Lumbopelvic Stability - Anterior Pelvic Tilt
Time frame: Baseline (week 0) and post-intervention (week 8)
Change in Lumbopelvic Stability - Lumbar Lordosis Angle
Time frame: Baseline (week 0) and post-intervention (week 8)
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 8 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coordinated Locomotor Training and Plyometric Training in people with Mechanical Low Back Pain and Lumbopelvic Pain, run by University of Faisalabad at 1 site in Pakistan.
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 7 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 8 Jun 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 Pakistan. 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?
Change in Pain Intensity (time frame: Baseline (week 0) and post-intervention (week 8)). 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 8 Jun 2026.