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Clinical Trials/NCT04074109
NCT04074109
Completed
Not Applicable

Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

Palo Alto Veterans Institute for Research1 site in 1 country34 target enrollmentDecember 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Palo Alto Veterans Institute for Research
Enrollment
34
Locations
1
Primary Endpoint
Multi-Dimensional Treatment Satisfaction Measure
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 6, 2019
End Date
December 17, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peter Bayley

Principal Investigator

Palo Alto Veterans Institute for Research

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Multi-Dimensional Treatment Satisfaction Measure

Time Frame: 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

Time Frame: during 12 weeks of treatment

% of randomized patients who attend ≥65% of treatment sessions

Attrition

Time Frame: during 12 weeks of treatment

number of randomized patients who drop out of treatment

Study Sites (1)

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