Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

NCT ID: NCT04074109

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-06
• Study Completion Date: 2021-12-17

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.

Conditions

Chronic Pain; Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Teleyoga

group will receive instruction via computer tablet

Group Type: EXPERIMENTAL

Teleyoga

Intervention Type: COMBINATION_PRODUCT

the yoga protocol will be delivered via a tablet computer to groups of participants

In-person yoga

group will receive instruction in-person

Group Type: ACTIVE_COMPARATOR

In-person yoga

Intervention Type: BEHAVIORAL

the yoga protocol will be delivered by a yoga instructor in the room to group of participants

Interventions

Teleyoga

the yoga protocol will be delivered via a tablet computer to groups of participants

Intervention Type: COMBINATION_PRODUCT

In-person yoga

the yoga protocol will be delivered by a yoga instructor in the room to group of participants

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role: lead

Responsible Party

Peter Bayley

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VA Palo Alto Health Care System

Palo Alto, California, United States

Countries

United States

References

Mahoney L, Pahade S, Mahoney H, Fitz K, Keaney A, Parker-Bridges K, Francisco JM, Lau A, Hitching R, Walker B, Gupta A, Jo B, Lohnberg JA, Clark JD, Bayley PJ. Randomized Feasibility Trial of Teleyoga versus In-Person Yoga for Treating Chronic Musculoskeletal Pain in Veterans. Res Sq [Preprint]. 2025 Jun 23:rs.3.rs-6265068. doi: 10.21203/rs.3.rs-6265068/v1.

Reference Type: DERIVED

PMID: 40678237 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R34AT010364

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BAY0006AGG

Identifier Type: -

Identifier Source: org_study_id