Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

Study Overview
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Brief Summary
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This feasibility study will evaluate yoga as a treatment for chronic musculoskeletal pain. The experimental treatment is yoga delivered via a tablet computer to participants at home (teleyoga). First, the investigators will develop a suitable protocol for teleyoga. Second, the investigators will demonstrate the feasibility of conducting a randomized controlled trial involving randomization to teleyoga or in-person yoga groups.

Detailed Description
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The first phase of the study is not randomized. In this phase, the first group of participants (n=10) will all participate in a tele-yoga class using an iPad loaned to them by the study. They will attend this treatment session from the comfort of their home or a location of their choice. Yoga treatment will last 12 weeks. At the end of treatment, veterans will provide feedback by completing a satisfaction questionnaire to rate various aspects of the teleyoga (e.g. technical challenges, ability to perform yoga through the video-conferencing platform, problems that occurred, and recommendations to improve the class, etc). The teleyoga protocol will be modified on the basis of this feedback and will be tested on a second group of participants (n=10). The second phase of the study will involve randomization of a further group of participants (n=30) to either the teleyoga developed in phase one, or in-person yoga.

Official Title
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Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

Conditions
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Chronic Pain, Musculoskeletal Pain

Intervention / Treatment
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* Combination Product: Teleyoga
* Behavioral: In-person yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veteran Medical clearance for participation by VA primary care provider Diagnosis of musculoskeletal pain > 6 months Minimum pain intensity of 4 at screening on 0-10 scale Any psychotropic treatments stable for at least 4 weeks before study English literacy Wireless Internet connection at home Exclusion Criteria: Current participation in another clinical trial Back surgery within the last 12 months Back pain related to a specific underlying cause, disease, or condition Baseline pain <4 or >9 on 0-10 scale Unstable, serious coexisting medical illness Unstable, serious coexisting mental illness Attended or practiced yoga ≥1 time in the past 12 months Active current suicidal plan or intent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teleyoga<br>group will receive instruction via computer tablet | Combination Product: Teleyoga<br>* the yoga protocol will be delivered via a tablet computer to groups of participants<br>|
| Active Comparator: In-person yoga<br>group will receive instruction in-person | Behavioral: In-person yoga<br>* the yoga protocol will be delivered by a yoga instructor in the room to group of participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multi-Dimensional Treatment Satisfaction Measure | A participant satisfaction measure [score range: 0 to 4]. The higher the value, the greater the treatment satisfaction | after 12 weeks of treatment | 
| Adherence to the Treatment Protocol | % of randomized patients who attend ≥65% of treatment sessions | during 12 weeks of treatment | 
| Attrition | number of randomized patients who drop out of treatment | during 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telehealth, yoga