The Effects of a Virtual Yoga Program on Patients With Chronic Pain
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Asimina Lazaridou, PhD
- Phone Number: 617-938-7810
- Email: alazaridou@bwh.harvard.edu
Study Contact Backup
- Name: Kayvon Afsarifard
- Email: kafsarifard@bwh.harvard.edu
Study Locations
-
-
Massachusetts
-
Chesnut Hill, Massachusetts, United States, 02467
- Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: Usual Care
|
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility
Time Frame: 8 weeks
|
retention, attendance, yoga practice minutes
|
8 weeks
|
|
Brief Pain Inventory
Time Frame: 8 weeks
|
Change in Pain Intensity and Interference assessed by the Brief Pain Inventory a
|
8 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Catastrophizing
Time Frame: 8 weeks
|
Change in pain catastrophizing as measured by the Pain Catastrophizing Scale Scored 0-52, with higher scores indicating worse outcome.
|
8 weeks
|
|
Perceived Stress
Time Frame: 8 weeks
|
Change in perceived stress as measured by the Perceived Stress Scale Scored 0-40, with higher scores indicating worse outcome.
|
8 weeks
|
|
Mindfulness
Time Frame: 8 weeks
|
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
|
|
Sleep
Time Frame: 8 weeks
|
PROMIS scale
|
8 weeks
|
|
Anxiety
Time Frame: 8 weeks
|
Change in Anxiety
|
8 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2021P002534
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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