N/A
Completed N=32
Yoga and Mantram for Chronic Pain and PTSD
Source: ClinicalTrials.gov NCT03816007 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Roland-Morris Disability Questionnaire (RMDQ) — 13.6; 14.3 score on a scale
Summary
PTSD is prevalent among Veterans and is associated with physical and functional impairments in addition to PTSD symptoms. Veterans with PTSD experience more chronic pain and pain-related functional limitations than Veterans without PTSD. Mind-body interventions such as yoga and meditation are non-pharmacological options for treating both chronic pain and PTSD. This pilot study will add an existing mantram repetition (MR) component designed for Veterans with PTSD to an active yoga intervention known to improve function in chronic back pain patients. The study will examine the acceptability of the interventions, adverse events, and the feasibility of recruitment, attendance, retention, treatment fidelity, and assessments by recruiting and randomizing 32 VA patients with PTSD to either yoga plus MR or to a relaxation/health education control. Health outcomes including pain-related function, pain, and PTSD symptoms will be measured. If feasible, the data will be used to plan a full-scale trial of enhanced yoga for pain in VA patients with PTSD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Roland-Morris Disability Questionnaire (RMDQ) |
13.6; 14.3 | — |
| SECONDARY BPI Pain Severity |
-0.15; -1.15 | — |
| SECONDARY Post-Traumatic Stress Disorder Checklist- Version 5 (PCL-5) |
-4.23; -9.80 | — |
| SECONDARY BPI Pain Interference |
-0.73; -0.46 | — |
| SECONDARY Insomnia Severity Index (ISI) |
-2.69; -0.30 | — |
| SECONDARY Quality of Life - EQ5D |
0.02; 0.10 | — |
| SECONDARY AUDIT-C |
-0.62; -0.10 | — |
| SECONDARY Fatigue |
-7.38; -4.90 | — |
Eligibility Criteria
Inclusion Criteria
- Veterans Affairs (VA) patients
- age > 18
- current diagnosis of PTSD
- score of 25 on Montreal Cognitive Assessment (MoCA)
- willing to reduce or cease opioid medications
- willing to attend 12-weeks of mind-body interventions and complete 3 assessments
Exclusion Criteria
- serious or unstable psychiatric illness
- e.g. psychosis, mania
- suicidal or homicidal ideation
- 2x in the last 6 months
- coexisting medical illness with yoga contraindicated
Data sourced from ClinicalTrials.gov (NCT03816007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.