Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

NCT04074109 | Completed Results DMC

• 2 other identifiers: BAY0006AGGR34AT010364
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Musculoskeletal Pain

Keywords

telehealth; yoga

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Teleyoga

EXPERIMENTAL

group will receive instruction via computer tablet

Combination Product: Teleyoga

In-person yoga

ACTIVE COMPARATOR

group will receive instruction in-person

Behavioral: In-person yoga

Interventions

Teleyoga COMBINATION_PRODUCT

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

Teleyoga

In-person yoga BEHAVIORAL

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

In-person yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 40678237 DERIVED

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Limitations and Caveats

Recruitment and treatment took place during the COVID-19 pandemic which may have influenced the results.

Results Point of Contact

• Title: Peter Bayley, PhD
• Organization: VA Palo Alto Health Care System

peter.bayley@va.gov

650-493-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: End-of-treatment assessments will be conducted by an assessor who is blind to treatment modality.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 29, 2019
• Study Start: December 6, 2019
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: April 18, 2023
• Results First Posted: March 23, 2023

Record last verified: 2023-03

Locations

US (1)