Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

Chronic Pain Clinical Trial

Official title:

Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04074109
• Other study ID #: BAY0006AGG
• Secondary ID: R34AT010364
• Status: Completed
• Phase: N/A
• Start date: December 6, 2019
• Est. completion date: December 17, 2021

Study information

• Verified date: March 2023
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 17, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

Combination Product:
• Teleyoga
the yoga protocol will be delivered via a tablet computer to groups of participants

Behavioral:
• In-person yoga
the yoga protocol will be delivered by a yoga instructor in the room to group of participants

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adherence to the Treatment Protocol	% of randomized patients who attend =65% of treatment sessions	during 12 weeks of treatment
Primary	Attrition	number of randomized patients who drop out of treatment	during 12 weeks of treatment