Chronic Low Back PainNCT02524158
Yoga for Veterans With CLBP
A study testing Yoga Therapy for CLBP in people with Chronic Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current treatment options have limited effectiveness. In addition to chronic pain, people with chronic low back pain experience increased disability, psychological symptoms such as depression, and reduced health-related quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Yoga Therapy for CLBP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Has a VA primary care provider
- Diagnosis of chronic low back pain > 6 months
- Willing to attend a yoga program or be assigned to delayed treatment with yoga
- Willing to complete 4 assessments
- English Literacy
- Has not begun new pain treatments or medications in the past month
- Willing to not change pain treatments (e.g., discontinue a treatment; increase medication dose) during the 12-week intervention period unless medically necessary
Who cannot join
- back surgery within the last 12 months
- back pain due to specific systemic problem (eg, lupus, scleroderma, fibromyalgia)
- morbid obesity (BMI > 40)
- Significant sciatica or nerve compression < 3 months or chronic lumbar radicular pain > 3 months
- Unstable, serious coexisting medical illness (eg, CHF, cancer, COPD, morbid obesity; dementia)
- Unstable, serious psychiatric illness (e.g., unmanaged psychosis, active substance dependence)
Show all 9Show fewer
- Insufficient data to rule out acute, metastatic disease, (unless primary care physician approves)
- Attended or practiced yoga > 1x in the last 12 months
- Positive Romberg test (with or without sensory neuropathy)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: Yoga Therapy to Improve Function Among Veterans With Chronic Low Back Pain
Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current treatment options have limited effectiveness. In addition to chronic pain, people with chronic low back pain experience increased disability, psychological symptoms such as depression, and reduced health-related quality of life. This randomized controlled study will examine the impact of yoga therapy for improving function and decreasing pain in VA patients with chronic low back pain. Although not every VA patient with chronic low back pain will choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to many VA patients. If yoga is effective, it could become an additional low-cost option that the VA can offer to better serve Veterans with chronic low back pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- Yoga Therapy for CLBP
- Keywords
- Yoga, Mind-Body Therapies, Chronic Low Back Pain, Military Veterans, VA patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga Therapy for CLBPBehavioural
Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | The yoga intervention will consist of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose. Receives: Behavioral: Yoga Therapy for CLBP |
| Delayed Treatment Control - Usual Care | No intervention | Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland-Morris Disability Questionnaire
The primary outcomes is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline and 12-weeks. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.
Measured: baseline to 12 weeks
Roland-Morris Disability Questionnaire
The primary outcome is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline, 12-weeks, and 6-months. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.
Measured: baseline to 6-months
Secondary outcomes (16)
Change From Baseline in Pain Intensity - Brief Pain Inventory at 12 Weeks
The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.
Measured: baseline to 12 weeks
Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months
The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.
Measured: baseline to 6 months
Change From Baseline Pain Interference - Brief Pain Inventory at 12 Weeks
The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 7 interference items used a as a measure of pain interference. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.
Measured: baseline to 12 weeks
Change From Baseline - Fatigue Severity Scale (FSS) at 12 Weeks
Fatigue (absence of energy) will be measured with the Fatigue Severity Scale (FSS). The FSS is a self-administered instrument developed to assess the impact and severity of fatigue. It consists of 9 items describing the functional impact of fatigue on daily life rated on a scale from 1 (strongly disagree) to 7 (strongly agree) with the total fatigue score ranging from 9-63 or an average score ranging from 1.0-7.0. Higher scores reflect greater fatigue severity and less energy.
Measured: baseline to 12 weeks
Change From Baseline - SF12 PCS at 12 Weeks
Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health status. The 12 items were selected from the SF-36 and tested through a series of stages. The PCS-12 and MCS-12 show similar levels of precision to the summary scores derived from the longer 36-item measure. PCS-12 and MCS-12 scores are transformed to a 0 to 100, with higher scores indicating better quality of life.
Measured: baseline to 12 weeks
Change From Baseline - SF12 MCS at 12 Weeks
Mental Component Scale - Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health status. The 12 items were selected from the SF-36 and tested through a series of stages. The PCS-12 and MCS-12 show similar levels of precision to the summary scores derived from the longer 36-item measure. PCS-12 and MCS-12 scores are transformed to a 0 to 100, with higher scores indicating better quality of life.
Measured: baseline to 12 weeks
Change From Baseline - EuroQOL 5D (EQ5D) at 12 Weeks
The EQ5D is a preference-based measure of health-related quality of life. The measure produces a single score ranging from 0 (death) to 1.00 (optimal health). Scores can be integrated with time to calculate Quality Adjusted Life Years.
Measured: baseline to 12 weeks
Change From Baseline - Center for Epidemiologic Studies Short Depression Scale (CES-D 10) at 12 Weeks
Depression will be assessed using the Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Derived from the full CES-D, there are 10 items that ask about the frequency of mood symptoms, rated on a 4-point Likert scale ranging from 0 (Never) to 3 (All of the Time). Scores range from 0 to 30, and higher scores indicate greater depression. A number of items are reverse-scored and a score of 10 or greater is considered depressed. Normative data on people with assorted chronic illnesses are available for comparisons.
Measured: baseline to 12 weeks
Change From Baseline - Brief Anxiety Inventory (BAI) at 12 Weeks
The Brief Anxiety Inventory (BAI) measures the severity of anxiety symptoms, particularly those that distinguish anxiety from depression. The BAI consists of 21 items, is self-administered and can be completed in 5 to 10 minutes. Items are scored on a scale of 0 to 3 and are summed to generate a total score. Scores range from 0 to 63, and higher scores indicate greater depression.
Measured: baseline to 12 weeks
Change From Baseline - Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks
The PSQI is a validated measure of sleep quality. The global PSQI score has a range of 0-21, with higher scores indicating worse sleep quality.
Measured: baseline to 12 weeks
Change From Baseline - Self-efficacy for Managing Low Back Pain at 12 Weeks
Self-efficacy for controlling CLBP reflects levels of confidence in the ability to influence the intensity of back pain symptoms and the impact that CLBP has on daily life. The questions are based on self-efficacy items developed for the Medical Outcomes Study in mixed chronic diseases. The wording of the items has been adapted to be specific to CLBP. The measure consists of 6 items, rated on a 6-point Likert scale, with each item ranging from 0-10. The total score is the mean of the 6 items with higher scores indicating greater self-efficacy for managing CLBP.
Measured: baseline to 12 weeks
Attendance/ Home Practice
Two indicators of the amount of yoga practiced by each participant will be used. Actual attendance of yoga sessions will be assessed using VA medical record data. Attendance can range from 0-24 sessions attended for those participants randomized to yoga. Self-reported practice of yoga at home will be assessed using a weekly participant yoga log. The self-report yoga log assesses whether they practiced yoga each day, the amount of minutes practiced, the use of instructions, the difficulty of poses, and the estimated level of physical activity or exertion.
Measured: 12 weeks
Change From Baseline - Range of Motion - Flexion at 12 Weeks
Spinal Range of Motion (ROM) will be measured using a Saunders Digital Inclinometer, a portable device which isolates lumbar ROM. The device is placed along the spine and uses a precise optical angular scanner. Forward bend angle measures how far forward and downward a person can bend at the waist, from a fully erect and/or normal standing position. The value typically ranges from 0-180 degrees, with higher values indicating greater flexibility.
Measured: baseline to 12 weeks
Change From Baseline - Grip Strength at 12 Weeks
Grip strength in both hands of each participant will be measured using an adjustable, hydraulic grip strength dynamometer (Jamar Hydraulic Hand Dynamometer). Three trials will be conducted for each hand. In cases of current pain flare-ups or recent procedures to a hand or wrist, the affected hand is not tested, and the result of the one other hand is used. If both hands are used the best performance of two trials will be selected for each side, and the average of the left and right hand will be used for analysis. The value measured is pounds of force exerted and typically ranges from 0 - 150 lbs, with higher numbers indicating greater grip strength.
Measured: baseline to 12 weeks
Change From Baseline - Lower Limb Strength and Balance - Eyes Open at 12 Weeks
The Single Leg Stance (SLS) is a commonly used measure of both lower leg strength and balance. A total of four trials were conducted - left and right leg with both eyes open and eyes closed. Each trial will be timed from the moment the participant lifts one foot off the floor until the moment they need to place it on the floor again. If the participant is able to stand on one leg for 60 seconds the trial will be stopped and they will be asked to switch side. Values range from 0 - 60 seconds with greater values indicating better balance.
Measured: baseline to 12 weeks
Change From Baseline - Lower Spine Stabilization - Core Strength at 12 Weeks
Time in seconds holding plank position on the elbows.
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Erik J Groessl, PhD BA BS, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524158
- Sponsor's protocol ID
- O7768-R
- Status last verified
- Sep 2018
- First submitted
- 10 Aug 2015
- Last updated
- 10 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Groessl EJ, Liu L, Richard EL, Tally SR. Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans. Med Care. 2020 Sep;58 Suppl 2 9S:S142-S148. doi: 10.1097/MLR.0000000000001356.
PubMed 32826784Groessl EJ, Liu L, Chang DG, Wetherell JL, Bormann JE, Atkinson JH, Baxi S, Schmalzl L. Yoga for Military Veterans with Chronic Low Back Pain: A Randomized Clinical Trial. Am J Prev Med. 2017 Nov;53(5):599-608. doi: 10.1016/j.amepre.2017.05.019. Epub 2017 Jul 20.
PubMed 28735778
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga Therapy to Improve Function Among Veterans With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02524158
- Acronym / sponsor ID
- O7768-R
- Conditions
- Chronic Low Back Pain
- Keywords
- Yoga, Mind-Body Therapies, Chronic Low Back Pain, Military Veterans, VA patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Posted 9 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current treatment options have limited effectiveness. In addition to chronic pain, people with chronic low back pain experience increased disability, psychological symptoms such as depression, and reduced health-related quality of life. This randomized controlled study will examine the impact of yoga therapy for improving function and decreasing pain in VA patients with chronic low back pain. Although not every VA patient with chronic low back pain will choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to many VA patients. If yoga is effective, it could become an additional low-cost option that the VA can offer to better serve Veterans with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Yoga Therapy for CLBPThe yoga intervention will consist of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose. |
| Delayed Treatment Control - Usual Care | No intervention | –Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a VA primary care provider
- Diagnosis of chronic low back pain > 6 months
- Willing to attend a yoga program or be assigned to delayed treatment with yoga
- Willing to complete 4 assessments
- English Literacy
Key exclusion criteria (9 listed)
- back surgery within the last 12 months
- back pain due to specific systemic problem (eg, lupus, scleroderma, fibromyalgia)
- morbid obesity (BMI > 40)
- Significant sciatica or nerve compression < 3 months or chronic lumbar radicular pain > 3 months
- Unstable, serious coexisting medical illness (eg, CHF, cancer, COPD, morbid obesity; dementia)
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 |
|---|---|---|
| Yoga Therapy for CLBPClasses begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose. | Behavioural | Yoga |
Primary outcome
Roland-Morris Disability Questionnaire
Time frame: baseline to 12 weeks
The primary outcomes is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline and 12-weeks. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.
Roland-Morris Disability Questionnaire
Time frame: baseline to 6-months
The primary outcome is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline, 12-weeks, and 6-months. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.
16 secondary outcomes
Change From Baseline in Pain Intensity - Brief Pain Inventory at 12 Weeks
Time frame: baseline to 12 weeks
Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months
Time frame: baseline to 6 months
Change From Baseline Pain Interference - Brief Pain Inventory at 12 Weeks
Time frame: baseline to 12 weeks
Change From Baseline - Fatigue Severity Scale (FSS) at 12 Weeks
Time frame: baseline to 12 weeks
Change From Baseline - SF12 PCS at 12 Weeks
Time frame: baseline to 12 weeks
Change From Baseline - SF12 MCS at 12 Weeks
Time frame: baseline to 12 weeks
Change From Baseline - EuroQOL 5D (EQ5D) at 12 Weeks
Time frame: baseline to 12 weeks
Change From Baseline - Center for Epidemiologic Studies Short Depression Scale (CES-D 10) at 12 Weeks
Time frame: baseline to 12 weeks
Change From Baseline - Brief Anxiety Inventory (BAI) at 12 Weeks
Time frame: baseline to 12 weeks
Change From Baseline - Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks
Time frame: baseline to 12 weeks
Change From Baseline - Self-efficacy for Managing Low Back Pain at 12 Weeks
Time frame: baseline to 12 weeks
Attendance/ Home Practice
Time frame: 12 weeks
Change From Baseline - Range of Motion - Flexion at 12 Weeks
Time frame: baseline to 12 weeks
Change From Baseline - Grip Strength at 12 Weeks
Time frame: baseline to 12 weeks
Change From Baseline - Lower Limb Strength and Balance - Eyes Open at 12 Weeks
Time frame: baseline to 12 weeks
Change From Baseline - Lower Spine Stabilization - Core Strength at 12 Weeks
Time frame: baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32826784Groessl EJ, Liu L, Richard EL, Tally SR. Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans. Med Care. 2020 Sep;58 Suppl 2 9S:S142-S148. doi: 10.1097/MLR.0000000000001356.
- Derived from this study: PubMed 28735778Groessl EJ, Liu L, Chang DG, Wetherell JL, Bormann JE, Atkinson JH, Baxi S, Schmalzl L. Yoga for Military Veterans with Chronic Low Back Pain: A Randomized Clinical Trial. Am J Prev Med. 2017 Nov;53(5):599-608. doi: 10.1016/j.amepre.2017.05.019. Epub 2017 Jul 20.
- 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.
Erik J Groessl, PhD BA BS principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Therapy for CLBP in people with Chronic Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
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 9 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 10 Oct 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Roland-Morris Disability Questionnaire (time frame: baseline to 12 weeks). The study lists 2 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 NCT02524158, which also lists 2 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 10 Oct 2018; AzTrials last refreshed its copy on 27 Oct 2026.