The Effects of a Virtual Yoga Program on Patients With Chronic Pain

Not Applicable

Recruiting

• Conditions: Chronic Pain

• Registration Number: NCT05211414
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

This research is being done to determine if remote yoga-based exercise can help reduce chronic pain. It will include three virtual research visits. This cohort study will include three remote research visits and an online questionnaire administration. In addition, participants will attend 8 weekly virtual yoga sessions with a daily 30-minute "homework assignment" of 30 minutes of video-guided yoga practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-01-27
• Study Start: 2023-03-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-15
• Primary Completion: 2024-03-15
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• chronic pain for > 6 months' duration
• on stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
• have an average pain score of 4/10 or greater over the previous week
• at least mild degree of sleep disturbance, defined as Pittsburgh Sleep Quality Index (PSQI) score >5
• are able to speak and understand English
• have access to a computer or tablet at home and have an email address
• are not currently engaged in a rigorous daily exercise routine (>5X/week)
• are willing and physically able to participate in virtual yoga-based exercise

Exclusion Criteria

• currently under active cancer treatment (chemo, infusion, ongoing radiation)
• acute osteomyelitis or acute bone disease
• current diagnosis of chronic systemic inflammatory diseases including rheumatoid arthritis and lupus
• present or past diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation
• pregnancy
• any clinically unstable systemic illness judged to interfere with exercise treatment
• a pain condition requiring urgent surgery
• an active addiction disorder, such as cocaine or IV heroin use, that would interfere with study participation
• contraindications to yoga (e.g., severe back or neck injury or surgery)
• regular meditation practice or other meditative practice (e.g tai-chi, meditative form of yoga or contemplative prayer) for >20 min/week in the past 2 years
• participating in any other therapeutic trial
• other medical condition that would interfere with ability to exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Interference	6 month follow up	Change in Pain as assessed by Brief Pain Inventory. Scored 0-10, with higher scores indicating worse outcome.
Anxiety	6 month follow up	Change in Anxiety as assessed by Patient Reported Outcomes Measurement Information System short form for anxiety Scored 7-35, with higher scores indicating worse outcome.

Secondary Outcome Measures

Name	Time	Method
Pain Intensity	8 weeks, 6 month follow up
Sleep	8 weeks, 6 month follow up
Pain Catastrophizing	8 weeks,6 month follow up	Change in pain catastrophizing as measured by the Pain Catastrophizing Scale Scored 0-52, with higher scores indicating worse outcome.
Perceived Stress	8 weeks,6 month follow up	Change in perceived stress as measured by the Perceived Stress Scale Scored 0-40, with higher scores indicating worse outcome.
Mindfulness	8 weeks,6 month follow up	Change in mindfulness as measured by the Five Facets of Mindfulness Questionnaire short form Scored 24-120, with higher scores indicating better outcome.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Chestnut Hill, Massachusetts, United States