Chronic Pain, Musculoskeletal Pain
Conditions
Keywords
telehealth, yoga
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.
Interventions
COMBINATION_PRODUCTTeleyoga
the yoga protocol will be delivered via a tablet computer to groups of participants
BEHAVIORALIn-person yoga
the yoga protocol will be delivered by a yoga instructor in the room to group of participants
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Palo Alto Veterans Institute for Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
End-of-treatment assessments will be conducted by an assessor who is blind to treatment modality.
Intervention model description
Participants are assigned to one of two groups in parallel for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multi-Dimensional Treatment Satisfaction Measure | after 12 weeks of treatment | A participant satisfaction measure \[score range: 0 to 4\]. The higher the value, the greater the treatment satisfaction |
| Adherence to the Treatment Protocol | during 12 weeks of treatment | % of randomized patients who attend ≥65% of treatment sessions |
| Attrition | during 12 weeks of treatment | number of randomized patients who drop out of treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Teleyoga group will receive instruction via computer tablet
Teleyoga: the yoga protocol will be delivered via a tablet computer to groups of participants | 18 |
| In-person Yoga group will receive instruction in-person
In-person yoga: the yoga protocol will be delivered by a yoga instructor in the room to group of participants | 16 |
| Total | 34 |
Baseline characteristics
| Characteristic | Teleyoga | Total | In-person Yoga |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 18.9 | 61.06 years STANDARD_DEVIATION 17.21 | 62 years STANDARD_DEVIATION 15.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 12 Participants | 23 Participants | 11 Participants |
| Region of Enrollment United States | 18 participants | 34 participants | 16 participants |
| Sex: Female, Male Female | 0 Participants | 12 Participants | 12 Participants |
| Sex: Female, Male Male | 18 Participants | 22 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 16 |
| other Total, other adverse events | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
Primary
Adherence to the Treatment Protocol
% of randomized patients who attend ≥65% of treatment sessions
Time frame: during 12 weeks of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Teleyoga | Adherence to the Treatment Protocol | 10 Participants |
| In-person Yoga | Adherence to the Treatment Protocol | 7 Participants |
Primary
Attrition
number of randomized patients who drop out of treatment
Time frame: during 12 weeks of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Teleyoga | Attrition | 5 Participants |
| In-person Yoga | Attrition | 8 Participants |
Primary
Multi-Dimensional Treatment Satisfaction Measure
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teleyoga | Multi-Dimensional Treatment Satisfaction Measure | 3.2 score on a scale | Standard Deviation 0.36 |
| In-person Yoga | Multi-Dimensional Treatment Satisfaction Measure | 3.6 score on a scale | Standard Deviation 0.19 |
Comparison: This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used. We report percentages and frequencies to show feasibility