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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05211414
• Other study ID #: 2021P002534
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: August 2023
• Source: Brigham and Women's Hospital
• Contact: Asimina Lazaridou, PhD
• Phone: 617-938-7810
• Email: alazaridou[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Yoga Based Daily Excercise
Subjects will be trained to perform 30 minutes of moderate level yoga daily, with instruction on breathing, self-awareness, and ways to modify poses to avoid pain. Subjects will be instructed in use of the email links to access the 30-minute instructive video. Subjects will attend weekly Zoom classes to learn additional postures and techniques, which will be reflected in their 30 minutes video (i.e. a new video for each week). At these weekly remote yoga classes, they will be asked about difficulties encountered and given advice about their personal home practice.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Interference	Change in Pain as assessed by Brief Pain Inventory. Scored 0-10, with higher scores indicating worse outcome.	6 month follow up
Primary	Anxiety	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.	6 month follow up
Secondary	Pain Catastrophizing	Change in pain catastrophizing as measured by the Pain Catastrophizing Scale Scored 0-52, with higher scores indicating worse outcome.	8 weeks,6 month follow up
Secondary	Perceived Stress	Change in perceived stress as measured by the Perceived Stress Scale Scored 0-40, with higher scores indicating worse outcome.	8 weeks,6 month follow up
Secondary	Mindfulness	Change in mindfulness as measured by the Five Facets of Mindfulness Questionnaire short form Scored 24-120, with higher scores indicating better outcome.	8 weeks,6 month follow up
Secondary	Pain Intensity		8 weeks, 6 month follow up
Secondary	Sleep		8 weeks, 6 month follow up