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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05211414
Collaborator
(none)
42
1
11.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Yoga Based Daily Excercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of a Virtual Yoga Program on Patients With Chronic Pain
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jan 15, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Pain Score [1 year]

    Change in Pain as assessed by Brief Pain Inventory. Scored 0-10, with higher scores indicating worse outcome.

  2. Sleep Quality [1 year]

    Change in Sleep Quality as assessed by Pittsburgh Sleep Quality Index. Scored 0-21, with higher scores indicating worse outcome.

  3. Anxiety [1 year]

    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.

  4. Depression [1 year]

    Change in Depression as assessed by Patient Reported Outcomes Measurement Information System short form for depression Scored 8-40, with higher scores indicating worse outcome.

Secondary Outcome Measures

  1. Pain Catastrophizing [1 year]

    Change in pain catastrophizing as measured by the Pain Catastrophizing Scale Scored 0-52, with higher scores indicating worse outcome.

  2. Perceived Stress [1 year]

    Change in perceived stress as measured by the Perceived Stress Scale Scored 0-40, with higher scores indicating worse outcome.

  3. Mindfulness [1 year]

    Change in mindfulness as measured by the Five Facets of Mindfulness Questionnaire short form Scored 24-120, with higher scores indicating better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asimina Lazaridou, PhD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT05211414
Other Study ID Numbers:
  • 2021P002534
First Posted:
Jan 27, 2022
Last Update Posted:
Apr 4, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022