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Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

Primary Purpose

Chronic Pain, Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teleyoga
In-person yoga
Sponsored by
Palo Alto Veterans Institute for Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring telehealth, yoga

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Teleyoga

In-person yoga

Arm Description

group will receive instruction via computer tablet

group will receive instruction in-person

Outcomes

Primary Outcome Measures

Multi-Dimensional Treatment Satisfaction Measure
A participant satisfaction measure [score range: 0 to 4]. The higher the value, the greater the treatment satisfaction
Adherence to the Treatment Protocol
% of randomized patients who attend ≥65% of treatment sessions
Attrition
number of randomized patients who drop out of treatment

Secondary Outcome Measures

Full Information

First Posted
August 5, 2019
Last Updated
March 22, 2023
Sponsor
Palo Alto Veterans Institute for Research
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04074109
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto Veterans Institute for Research
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Musculoskeletal Pain
Keywords
telehealth, yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two groups in parallel for the duration of the study.
Masking
Outcomes Assessor
Masking Description
End-of-treatment assessments will be conducted by an assessor who is blind to treatment modality.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teleyoga
Arm Type
Experimental
Arm Description
group will receive instruction via computer tablet
Arm Title
In-person yoga
Arm Type
Active Comparator
Arm Description
group will receive instruction in-person
Intervention Type
Combination Product
Intervention Name(s)
Teleyoga
Intervention Description
the yoga protocol will be delivered via a tablet computer to groups of participants
Intervention Type
Behavioral
Intervention Name(s)
In-person yoga
Intervention Description
the yoga protocol will be delivered by a yoga instructor in the room to group of participants
Primary Outcome Measure Information:
Title
Multi-Dimensional Treatment Satisfaction Measure
Description
A participant satisfaction measure [score range: 0 to 4]. The higher the value, the greater the treatment satisfaction
Time Frame
after 12 weeks of treatment
Title
Adherence to the Treatment Protocol
Description
% of randomized patients who attend ≥65% of treatment sessions
Time Frame
during 12 weeks of treatment
Title
Attrition
Description
number of randomized patients who drop out of treatment
Time Frame
during 12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

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Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

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