Chronic Low Back PainOPTYMNCT03504085

Overcoming Pain Through Yoga in the Military

A study testing Yoga: Active Hatha and Yoga: Restorative in people with Chronic Low Back Pain and Chronic Neck Pain, run by University of California, San Diego at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Our primary aim is to assess the feasibility of conducting yoga research among active-duty military personnel with Chronic Low Back Pain (CLBP) and/or Chronic Neck Pain (CNP). In addition, we will evaluate the yoga intervention preferences and refine an existing yoga intervention to address those needs. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Low Back Pain, Chronic Neck Pain
What is being tested?: Yoga: Active Hatha and Yoga: Restorative
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 2 sitesUnited States
Study dates: 1 May 2018to 31 May 2020
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

Diagnosis of CLBP or CNP > 6 months
Willing to attend a yoga program for 12 weeks
Willing to complete 3 assessments
English literacy
Have had no changes in pain treatments in the past month
Willing to not change pain treatments during study unless medically necessary
Have not practiced yoga more than 2x in the last 12 months

Who cannot join

Back or neck surgery within the last year
Back or neck pain due to specific systemic problem (e.g., lupus, scoliosis)
Severe vertebral disk problems,
Persistent sciatica or nerve compression > 3 months
Coexisting chronic pain problem (e.g., migraine headaches, fibromyalgia)
Serious or unstable psychiatric illness (e.g., psychosis, mania, episode, or substance dependence)
Major coexisting medical illness (e.g., cancer, COPD, morbid obesity)
Positive Romberg test (with or without sensory neuropathy)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UCSD's Health Services Research Center
San Diego, California, 92121
Navy Medical Center San Diego
San Diego, California, 92134

Other trials in United States

About this study

Official title: Mind/Body Interventions for Chronic Low Back and Neck Pain in Military Personnel

Read the detailed description

In preparation for a full-scale study via a subsequent R01 proposal, our study objective is to examine the feasibility and acceptability of conducting a yoga RCT among active-duty military personnel with CLBP/CNP in military and community settings. The study will be conducted in two phases: Phase 1 (completed) involved obtaining IRB approval to conduct research in military settings, collecting qualitative data from stakeholders on attitudes and preferences for yoga interventions, and refining the existing Yoga for CLBP intervention for the needs of active-duty military and persons with CNP. Phase 2 will recruit and randomize 50 military personnel with CLBP or CNP to either active hatha or restorative yoga. Pain interference, pain severity, physical function, opioid medication use, and mental health outcomes are of primary interest. Mechanisms will also be studied.

The specific aims are as follows:

Aim 1: Evaluate and navigate barriers and facilitators for obtaining IRB approval to conduct randomized controlled intervention studies with active-duty military personnel.

Aim 2: Evaluate the acceptability of and preferences for yoga interventions among active-duty military personnel with CLBP/CNP.

Aim 3: Refine and modify the existing Yoga for CLBP intervention to address CNP, and the needs of active-duty military personnel.

Aim 4: Evaluate the feasibility of recruitment of active-duty military personnel with CLBP/CNP into a yoga RCT.

Aim 5: Evaluate the adherence of this population to the two yoga interventions. Aim 6: Obtain effect size estimates to inform power analyses for a full-scale RCT.

Accomplishing these aims will prepare us for an R01 proposal to study the efficacy of yoga for military personnel with CLBP/CNP in a full-scale randomized, controlled trial. To be successful and maximize the scientific knowledge obtained from an R01 study, it is crucial to first establish working relationships with military researchers, ensure that recruitment and randomized assignment are feasible, pilot test measurement strategies, and ensure that both interventions will be well-attended and have been optimally chosen.

Conditions: Chronic Low Back Pain, Chronic Neck Pain
Being tested: Yoga: Active Hatha, Yoga: Restorative
Keywords: Chronic Low Back Pain, CLBP, Chronic Neck Pain, CNP, Chronic Pain, Military, Active Duty, Yoga, Mindbody
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Yoga: Active HathaOther
Also called Active
Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations
Yoga: RestorativeOther
Also called Non-Active
Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.

Study groups in NCT03504085
Study group	Role	What they receive
Hatha Yoga	Experimental	This arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended. Receives: Other: Yoga: Active Hatha
Restorative Yoga	Active comparator	This arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks. Receives: Other: Yoga: Restorative

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Interference
Brief Pain Inventory (BPI) : Self-Report measure of pain interference and pain severity consisting of 14 items. The measure includes front and back body diagrams to describe areas of pain, four pain severity items and seven pain interference items rated on 0-10 scales, and one question about percentage of pain relief by analgesics. The pain interference score is the mean of the 7 interference items. The pain severity score is the mean of 4 severity items.
Scale scores are the mean of relevant items. Thus, scores range from 0-10 with higher scores indicating more pain interference.
Measured: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Secondary outcomes (3)

Roland-Morris Disability Questionnaire
Self-report measure consisting of 23 questions that ask about limitations experienced for a variety of daily activities.
Scale scores are the sum of items endorsed, thus scores range from 0-23 with higher scores indicating more back pain-related disability.
Measured: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
BPI Pain Severity
Brief Pain Inventory (BPI) : Self-Report measure of pain severity consisting of 4 items. The measure includes front and back body diagrams to describe areas of pain, four pain severity items and seven pain interference items rated on 0-10 scales, and one question about percentage of pain relief by analgesics. The pain severity score is the mean of 4 severity items.
Scale scores are the mean of relevant items. Thus, scores range from 0-10 with higher scores indicating greater pain severity.
Measured: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Neck Disability Index
Ten-item self-report measure to assess neck pain interference in daily life activities.
Each of the 10 items is scored from 0 - 5. The items are summed and scores range from 0-50 with higher scores indicating greater disability due to neck pain.
Measured: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201831 May 2020

First posted20 Apr 2018
Study start1 May 2018
Primary completion31 May 2020
Study completion31 May 2020

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 (1)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 University of California, San DiegoThe 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: We will be conducting a pilot RCT with two types of yoga interventions. A total of 50 participants will be randomized to attend either active Hatha yoga or restorative yoga. Enrollment will be conducted on a rolling basis.
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03504085
Sponsor's protocol ID: R34AT009073-01
Other IDs: R34AT009073-01
Acronym: OPTYM
Status last verified: Feb 2023
First submitted: 2 Mar 2018
Last updated: 17 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Groessl EJ, Casteel D, McKinnon S, McCarthy A, Schmalzl L, Chang DG, Fowler IM, Park CL. Comparing Types of Yoga for Chronic Low Back and Neck Pain in Military Personnel: A Feasibility Randomized Controlled Trial. Glob Adv Health Med. 2022 Jun 16;11:2164957X221094596. doi: 10.1177/2164957X221094596. eCollection 2022.
PubMed 35734420

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mind/Body Interventions for Chronic Low Back and Neck Pain in Military Personnel
ClinicalTrials.gov ID: NCT03504085
Acronym / sponsor ID: OPTYM / R34AT009073-01
Conditions: Chronic Low Back Pain, Chronic Neck Pain
Keywords: Chronic Low Back Pain, CLBP, Chronic Neck Pain, CNP, Chronic Pain, Military, Active Duty, Yoga
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Collaborators: United States Naval Medical Center, San Diego, National Center for Complementary and Integrative Health (NCCIH)
Study start: 1 May 2018 (actual)
Primary completion: 31 May 2020 (actual)
Study completion: 31 May 2020 (actual)
First posted: 20 Apr 2018 (actual)
Results: Posted 17 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The specific aims are as follows:

Aim 1: Evaluate and navigate barriers and facilitators for obtaining IRB approval to conduct randomized controlled intervention studies with active-duty military personnel.

Aim 2: Evaluate the acceptability of and preferences for yoga interventions among active-duty military personnel with CLBP/CNP.

Aim 3: Refine and modify the existing Yoga for CLBP intervention to address CNP, and the needs of active-duty military personnel.

Aim 4: Evaluate the feasibility of recruitment of active-duty military personnel with CLBP/CNP into a yoga RCT.

Aim 5: Evaluate the adherence of this population to the two yoga interventions. Aim 6: Obtain effect size estimates to inform power analyses for a full-scale RCT.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: We will be conducting a pilot RCT with two types of yoga interventions. A total of 50 participants will be randomized to attend either active Hatha yoga or restorative yoga. Enrollment will be conducted on a rolling basis.

Arm	Type	Receives
Hatha Yoga	Experimental	Other: Yoga: Active HathaThis arm will receive the active Hatha yoga intervention. Instructors lead participants through various yoga poses for 60-minutes, 1-2x weekly for 12 weeks, and daily home practice is recommended.
Restorative Yoga	Active comparator	Other: Yoga: RestorativeThis arm will receive a restorative yoga intervention. Instructors guide participants through relaxation exercises, typically with eyes closed, laying down, and minimal movement 60-minutes, 1-2x weekly for 12 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosis of CLBP or CNP > 6 months
Willing to attend a yoga program for 12 weeks
Willing to complete 3 assessments
English literacy
Have had no changes in pain treatments in the past month

Key exclusion criteria (8 listed)

Back or neck surgery within the last year
Back or neck pain due to specific systemic problem (e.g., lupus, scoliosis)
Severe vertebral disk problems,
Persistent sciatica or nerve compression > 3 months
Coexisting chronic pain problem (e.g., migraine headaches, fibromyalgia)

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: Active HathaAlso: ActiveClassical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations	Other	Hatha Yoga
Yoga: RestorativeAlso: Non-ActiveRestorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.	Other	Restorative Yoga

Primary outcome

Pain Interference
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Brief Pain Inventory (BPI) : Self-Report measure of pain interference and pain severity consisting of 14 items. The measure includes front and back body diagrams to describe areas of pain, four pain severity items and seven pain interference items rated on 0-10 scales, and one question about percentage of pain relief by analgesics. The pain interference score is the mean of the 7 interference items. The pain severity score is the mean of 4 severity items. Scale scores are the mean of relevant items. Thus, scores range from 0-10 with higher scores indicating more pain interference.

3 secondary outcomes

Roland-Morris Disability Questionnaire
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
BPI Pain Severity
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported
Neck Disability Index
Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Results and safety

Results posted to the registry on 17 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hatha Yoga	24	21
Restorative Yoga	25	21

Primary outcome: Pain Interference

Time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported. Mean (Standard Deviation). Unit: score on a scale

Measure	Hatha Yoga n = 21	Restorative Yoga n = 21
Baseline	4.2 (2.2)	4.0 (2.4)
12 weeks	3.9 (2.4)	3.2 (2.5)

Population analysed: Effect size

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hatha Yoga	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24
Restorative Yoga	0 of 25 (0%)	4 of 25 (16%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35734420Groessl EJ, Casteel D, McKinnon S, McCarthy A, Schmalzl L, Chang DG, Fowler IM, Park CL. Comparing Types of Yoga for Chronic Low Back and Neck Pain in Military Personnel: A Feasibility Randomized Controlled Trial. Glob Adv Health Med. 2022 Jun 16;11:2164957X221094596. doi: 10.1177/2164957X221094596. eCollection 2022.
Individual participant dataSharing planned: No

Related trials for Chronic 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
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

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 Groessl, Ph.D. principal investigator

University of California, San Diego

Ian Fowler, MD principal investigator

Navy Medical Center San Diego

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Yoga: Active Hatha and Yoga: Restorative in people with Chronic Low Back Pain and Chronic Neck Pain, run by University of California, San Diego at 2 sites 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 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 17 Feb 2023). 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?

Pain Interference (time frame: assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported). 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 NCT03504085, which also lists 1 linked publication.

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 17 Feb 2023.