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Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

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ClinicalTrials.gov Identifier: NCT04074109
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : June 15, 2021
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Peter Bayley, 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Musculoskeletal Pain Combination Product: Teleyoga Behavioral: In-person yoga Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single (Outcomes Assessor)
Masking Description: End-of-treatment assessments will be conducted by an assessor who is blind to treatment modality.
Primary Purpose: Treatment
Official Title: Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain
Actual Study Start Date : December 6, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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




Primary Outcome Measures :
  1. Multi-Dimensional Treatment Satisfaction Measure [ Time Frame: after 12 weeks of treatment ]
    A participant satisfaction measure [score range: 0 to 152]. The higher the value, the greater the treatment satisfaction


Secondary Outcome Measures :
  1. Adherence to the treatment protocol [ Time Frame: at study completion, an average of 2 years ]
    % of randomized patients who attend ≥65% of treatment sessions

  2. Rate of attrition [ Time Frame: at study completion, an average of 2 years ]
    % of randomized patients who drop out of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074109


Locations
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United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Shweta Pahade    650-304-1517    Shweta.Pahade@va.gov   
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
National Center for Complementary and Integrative Health (NCCIH)
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Responsible Party: Peter Bayley, Principal Investigator, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT04074109    
Other Study ID Numbers: BAY0006AGG
R34AT010364 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Bayley, Palo Alto Veterans Institute for Research:
telehealth
yoga
Additional relevant MeSH terms:
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Musculoskeletal Pain
Chronic Pain
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases