Clinical trial NCT04074109: Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain
Official title: Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain
Keywords: telehealth
yoga
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-08-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Multi-Dimensional Treatment Satisfaction Measure
timeFrame: after 12 weeks of treatment
measure: Adherence to the Treatment Protocol
timeFrame: during 12 weeks of treatment
measure: Attrition
timeFrame: during 12 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References: