NCT02378025

Brief Summary

The purpose of this study is to determine whether yoga is effective for the treatment of chronic pain in Gulf War Illness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

June 11, 2020

Completed
Last Updated

June 11, 2020

Status Verified

May 1, 2020

Enrollment Period

2.8 years

First QC Date

February 26, 2015

Results QC Date

May 6, 2020

Last Update Submit

May 29, 2020

Conditions

Chronic PainGulf War IllnessChronic Illness

Keywords

Chronic PainVeteransGulf War Illness

Outcome Measures

Primary Outcomes (2)

  • Pain (Brief Pain Inventory - Short Form) - Pain Severity

    Model - estimated change in the Pain Severity subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment

    Week 10 minus Week 0

  • Pain (Brief Pain Inventory - Short Form) - Pain Interference

    Model - estimated change in the Pain Interference subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment.

    Week 10 minus Week 0

Secondary Outcomes (4)

  • Fatigue (6-Minute Walk Test)

    Week 0, Week 10

  • Change in Number of Participants Who Used Analgesic Medication

    Week 0, Week 10

  • Change in Number of Participants Who Used Nonsteroidal Anti-inflammatory Drugs

    Week 0, Week 10

  • Change in Number of Participants Who Used Opiate Medication

    Week 0, Week 10

Study Arms (2)

Yoga Group

EXPERIMENTAL

Postures, meditation, breathing exercises

Behavioral: Yoga Group

Pain Management Wellness Group

ACTIVE COMPARATOR

Behavioral medicine

Behavioral: Pain Management Wellness Group

Interventions

Yoga GroupBEHAVIORAL

A 10-week yoga course designed to treat pain.

Yoga Group
Pain Management Wellness GroupBEHAVIORAL

A 10-week behavioral therapy course designed to treat pain.

Pain Management Wellness Group

Eligibility Criteria

Age42 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Served in the military in 1990-1991, regardless of deployment.
  • History of chronic pain.
  • Able to attend weekly visits at the study center for 10 weeks.
  • If on a psychotropic medication, the regimen will be stable for at least 4 weeks, prior to entry in the study.

You may not qualify if:

  • Participation in another clinical trial.
  • Unable to visit the study center.
  • Unable to stand or walk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (3)

  • Allende S, Mathersul DC, Schulz-Heik JR, Avery TJ, Mahoney L, Bayley PJ. Yoga is effective for treating chronic pain in veterans with Gulf War Illness at long-term follow-up. BMC Complement Med Ther. 2023 Sep 13;23(1):319. doi: 10.1186/s12906-023-04145-y.

    PMID: 37704984DERIVED

  • Mathersul DC, Dixit K, Avery TJ, Schulz-Heik RJ, Zeitzer JM, Mahoney LA, Cho RH, Bayley PJ. Heart rate and heart rate variability as outcomes and longitudinal moderators of treatment for pain across follow-up in Veterans with Gulf War illness. Life Sci. 2021 Jul 15;277:119604. doi: 10.1016/j.lfs.2021.119604. Epub 2021 May 11.

    PMID: 33984356DERIVED

  • Bayley PJ, Schulz-Heik RJ, Cho R, Mathersul D, Collery L, Shankar K, Ashford JW, Jennings JS, Tang J, Wong MS, Avery TJ, Stanton MV, Meyer H, Friedman M, Kim S, Jo B, Younger J, Mathews B, Majmundar M, Mahoney L. Yoga is effective in treating symptoms of Gulf War illness: A randomized clinical trial. J Psychiatr Res. 2021 Nov;143:563-571. doi: 10.1016/j.jpsychires.2020.11.024. Epub 2020 Nov 11.

    PMID: 33218747DERIVED

MeSH Terms

Conditions

Chronic PainChronic Disease

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Results Point of Contact

Title
Dr. Peter Bayley
Organization
Veterans Affairs Palo Alto Healthcare System
peter.bayley@va.gov
650 493-5000

Study Officials

  • Peter Bayley, PhD

    VA Palo Alto Heath Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Cognitive Neuroscience

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 4, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

June 11, 2020

Results First Posted

June 11, 2020

Record last verified: 2020-05

Locations

US(1)