Overcoming Pain Through Yoga in the Military

NCT03504085 | Completed Results DMC

• 1 other identifier: R34AT009073-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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

Conditions

Chronic Low Back Pain; Chronic Neck Pain

Keywords

Chronic Low Back Pain; CLBP; Chronic Neck Pain; CNP; Chronic Pain; Military; Active Duty; Yoga; Mindbody

Outcome Measures

Primary Outcomes (1)

• 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.

  assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Secondary Outcomes (3)

• Roland-Morris Disability Questionnaire

  assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

• BPI Pain Severity

  assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

• Neck Disability Index

  assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Other Outcomes (12)

• Health Related Quality of Life (HRQOL) Short-form 12 (SF12) - Physical

  assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

• HRQOL - SF12 - Mental Health

  assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

• The Fatigue Severity Scale (FSS)

  assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported

Study Arms (2)

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.

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.

Other: Yoga: Restorative

Interventions

Yoga: Active Hatha OTHER

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

Also known as: Active

Hatha Yoga

Yoga: Restorative OTHER

Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.

Also known as: Non-Active

Restorative Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead
• United States Naval Medical Center, San Diego: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

UCSD's Health Services Research Center

San Diego, California, 92121, United States

Location

Navy Medical Center San Diego

San Diego, California, 92134, United States

Location

Related Publications (1)

• 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.

  PMID: 35734420 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Erik Groessl, PhD
• Organization: UC San Diego

egroessl@ucsd.edu

858-642-6347

Study Officials

• Erik Groessl, Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Ian Fowler, MD

  Navy Medical Center San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: April 20, 2018
• Study Start: May 1, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: February 17, 2023
• Results First Posted: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)