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NCT03816007 · ClinicalTrials.gov registry record · NA
Yoga and Mantram for Chronic Pain and PTSD
A NA study of Post Traumatic Stress Disorder and Chronic Low Back Pain, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03816007: Completed NA study of Post Traumatic Stress Disorder and Chronic Low Back Pain, sponsored by VA Office of Research and Development.
NCT03816007 is a NA study of Post Traumatic Stress Disorder and Chronic Low Back Pain that has completed, run by VA Office of Research and Development. The registered enrollment target is 32 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03816007, a NA study of Post Traumatic Stress Disorder and Chronic Low Back Pain, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The RMDQ has 23 questions asking about limitations experienced with daily activities. The scale is reliable and well validated. It has been used in other yoga studies. Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.
Conditions Studied
Interventions
- BEHAVIORAL Yoga and Mantram Repetition
- BEHAVIORAL Veteran Calm
Study Locations (1)
California
- VA San Diego Healthcare System, San Diego, CA - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2022-01-31 |
| Phase | NA |
What the finished NCT03816007 record still lists
NCT03816007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Yoga and Mantram Repetition is the first listed.
NCT03816007 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03816007 about?
NCT03816007 is a clinical study titled "Yoga and Mantram for Chronic Pain and PTSD". 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-ph...
What is the current status of trial NCT03816007?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2021-04-01. Estimated completion is 2022-01-31.
What conditions does trial NCT03816007 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Chronic Low Back Pain, Chronic Neck Pain.
What interventions are being tested in trial NCT03816007?
The interventions under investigation include: Yoga and Mantram Repetition (BEHAVIORAL), Veteran Calm (BEHAVIORAL).
Who is sponsoring clinical trial NCT03816007?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03816007 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03816007's enrollment target sits among peer trials
32 206th of 262 higher than 56 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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