Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain; Musculoskeletal Pain

• Registration Number: NCT04074109
• Lead Sponsor: Palo Alto Veterans Institute for Research

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-29
• Study Start: 2019-12-06
• Primary Completion: 2021-12-17
• Study Completion: 2021-12-17
• Results First Submitted: 2023-01-31
• Results First Submitted QC: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Results First Posted: 2023-03-23
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States