Clinical trial
Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain
Name
BAY0006AGG
Description
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.
Trial arms
Trial start
2019-12-06
Estimated PCD
2021-12-17
Trial end
2021-12-17
Status
Completed
Treatment
Teleyoga
the yoga protocol will be delivered via a tablet computer to groups of participants
Arms:
Teleyoga
In-person yoga
the yoga protocol will be delivered by a yoga instructor in the room to group of participants
Arms:
In-person yoga
Size
34
Primary endpoint
Multi-Dimensional Treatment Satisfaction Measure
after 12 weeks of treatment
Adherence to the Treatment Protocol
during 12 weeks of treatment
Attrition
during 12 weeks of treatment
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to one of two groups in parallel for the duration of the study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'End-of-treatment assessments will be conducted by an assessor who is blind to treatment modality.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}
Updated at
2023-04-18
1 organization
1 product
2 indications
Organization
Palo Alto Veterans Institute for ResearchProduct
TeleyogaIndication
Chronic PainIndication
Musculoskeletal Pain