NCT03504085: OPTYM

Overcoming Pain Through Yoga in the Military

Completed NA Results posted Last updated 17 February 2023

What this trial tests

NA trial testing Yoga: Active Hatha in Chronic Low Back Pain in 49 participants. Completed in 31 May 2020.

Timeline

1 May 2018

Primary endpoint
31 May 2020

31 May 2020

Quick facts

Lead sponsor	University of California, San Diego
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	49
Start date	1 May 2018
Primary completion	31 May 2020
Estimated completion	31 May 2020
Sites	2 locations across United States

Drugs / interventions tested

• Yoga: Active Hatha
• Yoga: Restorative

Conditions studied

• Chronic Low Back Pain — all drugs for Chronic Low Back Pain →
• Chronic Neck Pain — all drugs for Chronic Neck Pain →

Sponsor

University of California, San Diego

Who can join

18 and older, any sex, with Chronic Low Back Pain or Chronic Neck Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Interference Primary · 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.

Baseline

Group	Value	95% CI
Hatha Yoga	4.2	± 2.2
Restorative Yoga	4.0	± 2.4

12 weeks

Group	Value	95% CI
Hatha Yoga	3.9	± 2.4
Restorative Yoga	3.2	± 2.5

Roland-Morris Disability Questionnaire Secondary · assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

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.

Baseline

Group	Value	95% CI
Hatha Yoga	10.8	± 5.2
Restorative Yoga	10.0	± 5.6

12 weeks

Group	Value	95% CI
Hatha Yoga	10.1	± 6.3
Restorative Yoga	7.6	± 6.1

BPI Pain Severity Secondary · assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

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.

Baseline

Group	Value	95% CI
Hatha Yoga	4.7	± 1.7
Restorative Yoga	4.7	± 1.8

12 weeks

Group	Value	95% CI
Hatha Yoga	4.0	± 2.3
Restorative Yoga	3.7	± 1.9

Neck Disability Index Secondary · assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

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.

Baseline

Group	Value	95% CI
Hatha Yoga	14.3	± 9.3
Restorative Yoga	12.1	± 9.0

12 weeks

Group	Value	95% CI
Hatha Yoga	14.0	± 10.7
Restorative Yoga	10.0	± 8.9

Health Related Quality of Life (HRQOL) Short-form 12 (SF12) - Physical Secondary · assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

12-Item self-report measure on individual's views about their physical health. Scores are scaled to range from 0-100 with higher scores indicating better physical quality of life.

Baseline

Group	Value	95% CI
Hatha Yoga	33.1	± 7.3
Restorative Yoga	36.5	± 10.5

12 weeks

Group	Value	95% CI
Hatha Yoga	37.0	± 8.1
Restorative Yoga	39.2	± 9.6

HRQOL - SF12 - Mental Health Secondary · assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Mental Component Score for the SF12 Scores are scaled to range from 0-100 with higher scores indicating better mental quality of life.

Baseline

Group	Value	95% CI
Hatha Yoga	47.1	± 11.6
Restorative Yoga	49.5	± 9.5

12 weeks

Group	Value	95% CI
Hatha Yoga	45.2	± 12.5
Restorative Yoga	47.1	± 10.6

The Fatigue Severity Scale (FSS) Secondary · assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

The Fatigue Severity Scale (FSS) assesses the impact and severity of fatigue with 9 items. A score of \> 4.0 constitutes severe fatigue.The measure has good psychometrics for pain disorders. This is a 9-item questionnaire with questions related to how fatigue interferes with certain activities and severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score indicate greater fatigue severity.

Baseline

Group	Value	95% CI
Hatha Yoga	4.0	± 1.4
Restorative Yoga	4.0	± 1.5

12 weeks

Group	Value	95% CI
Hatha Yoga	4.4	± 1.6
Restorative Yoga	3.8	± 1.6

PROMIS - Pain Intensity Secondary · assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

PROMIS (Patient-Reported Outcomes Measurement Information System) measure - Pain Intensity The PROMIS Pain Intensity instrument consists of three items with 5 response options ranging from 1 ("had no pain") to 5 ("very severe") addressing how much pain the person experiences now and in the past 7 days. The raw score is the sum of the three questions, with a minimum of 3 and a maximum score of 15, with higher scores indicating greater pain intensity.

Baseline

Group	Value	95% CI
Hatha Yoga	9.8	± 1.7
Restorative Yoga	9.5	± 2.3

12 weeks

Group	Value	95% CI
Hatha Yoga	9.0	± 2.4
Restorative Yoga	8.6	± 2.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Hatha Yoga

Serious: 0/24 (0%)

Deaths: 0/24

Restorative Yoga

Serious: 0/25 (0%)

Deaths: 0/25

Other adverse events (5 terms — click to expand)

Reaction	System	Hatha Yoga	Restorative Yoga
leg surgery	Musculoskeletal and connective tissue disorders	—	—
Broken foot or ankle	Musculoskeletal and connective tissue disorders	—	—
Back surgery	Musculoskeletal and connective tissue disorders	—	—
Unspecified surgery	Surgical and medical procedures	—	—
Shoulder injury	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT03504085 adverse events section.

Sponsor's own description

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. The study will prepare us for a R01 funded pragmatic clinical trial of yoga for CLBP and CNP in active-duty military.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Yoga for chronic non-specific low back pain.
   Wieland LS, Skoetz N, Pilkington K, Harbin S, et al · · 2022 · cited 29× · PMID 36398843 · DOI 10.1002/14651858.cd010671.pub3
2. Comparing Types of Yoga for Chronic Low Back and Neck Pain in Military Personnel: A Feasibility Randomized Controlled Trial.
   Groessl EJ, Casteel D, McKinnon S, McCarthy A, et al · · 2022 · cited 7× · PMID 35734420 · DOI 10.1177/2164957x221094596