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Completed

NCT Number: NCT04074109

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teleyoga

Combination Product

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

In-person yoga

Behavioral

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

Primary outcomes

  1. 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

  2. Adherence to the Treatment Protocol

    Time frame: during 12 weeks of treatment

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

  3. Attrition

    Time frame: during 12 weeks of treatment

    number of randomized patients who drop out of treatment

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2019
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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