Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Chronic Pain
• Intervention / Treatment: Combination product: Teleyoga; Behavioral: In-person yoga

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the treatment protocol	% of randomized patients who attend ≥65% of treatment sessions	at study completion, an average of 2 years
Rate of attrition	% of randomized patients who drop out of treatment	at study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Palo Alto Veterans Institute for Research
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Actual): December 17, 2021
• Study Completion (Actual): December 17, 2021

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: yoga; telehealth
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Chronic Pain; Musculoskeletal Pain
• Other Study ID Numbers: BAY0006AGG; R34AT010364 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No