Ignite Creation Date:
2024-05-06 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03504085
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2018-03-02
Brief Title:
Overcoming Pain Through Yoga in the Military
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
MindBody Interventions for Chronic Low Back and Neck Pain in Military Personnel
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTYM
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 andor 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
Detailed Description:
In preparation for a full-scale study via a subsequent R01 proposal our study objective is to examine the feasibility and acceptability of conducting a yoga RCT among active-duty military personnel with CLBPCNP in military and community settings The study will be conducted in two phases Phase 1 completed involved obtaining IRB approval to conduct research in military settings collecting qualitative data from stakeholders on attitudes and preferences for yoga interventions and refining the existing Yoga for CLBP intervention for the needs of active-duty military and persons with CNP Phase 2 will recruit and randomize 50 military personnel with CLBP or CNP to either active hatha or restorative yoga Pain interference pain severity physical function opioid medication use and mental health outcomes are of primary interest Mechanisms will also be studied
The specific aims are as follows
Aim 1 Evaluate and navigate barriers and facilitators for obtaining IRB approval to conduct randomized controlled intervention studies with active-duty military personnel
Aim 2 Evaluate the acceptability of and preferences for yoga interventions among active-duty military personnel with CLBPCNP
Aim 3 Refine and modify the existing Yoga for CLBP intervention to address CNP and the needs of active-duty military personnel
Aim 4 Evaluate the feasibility of recruitment of active-duty military personnel with CLBPCNP into a yoga RCT
Aim 5 Evaluate the adherence of this population to the two yoga interventions Aim 6 Obtain effect size estimates to inform power analyses for a full-scale RCT
Accomplishing these aims will prepare us for an R01 proposal to study the efficacy of yoga for military personnel with CLBPCNP in a full-scale randomized controlled trial To be successful and maximize the scientific knowledge obtained from an R01 study it is crucial to first establish working relationships with military researchers ensure that recruitment and randomized assignment are feasible pilot test measurement strategies and ensure that both interventions will be well-attended and have been optimally chosen
The specific aims are as follows
Aim 1 Evaluate and navigate barriers and facilitators for obtaining IRB approval to conduct randomized controlled intervention studies with active-duty military personnel
Aim 2 Evaluate the acceptability of and preferences for yoga interventions among active-duty military personnel with CLBPCNP
Aim 3 Refine and modify the existing Yoga for CLBP intervention to address CNP and the needs of active-duty military personnel
Aim 4 Evaluate the feasibility of recruitment of active-duty military personnel with CLBPCNP into a yoga RCT
Aim 5 Evaluate the adherence of this population to the two yoga interventions Aim 6 Obtain effect size estimates to inform power analyses for a full-scale RCT
Accomplishing these aims will prepare us for an R01 proposal to study the efficacy of yoga for military personnel with CLBPCNP in a full-scale randomized controlled trial To be successful and maximize the scientific knowledge obtained from an R01 study it is crucial to first establish working relationships with military researchers ensure that recruitment and randomized assignment are feasible pilot test measurement strategies and ensure that both interventions will be well-attended and have been optimally chosen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34AT009073-01 | NIH | None | httpsreporternihgovquickSearchR34AT009073-01 |