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

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Based Daily Excercise
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga Based Daily Excercise

Usual Care

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2021
Last Updated
August 11, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05211414
Brief Title
The Effects of a Virtual Yoga Program on Patients With Chronic Pain
Official Title
The Effects of a Virtual Yoga Program on Patients With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga Based Daily Excercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Yoga Based Daily Excercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Interference
Description
Change in Pain as assessed by Brief Pain Inventory. Scored 0-10, with higher scores indicating worse outcome.
Time Frame
6 month follow up
Title
Anxiety
Description
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.
Time Frame
6 month follow up
Secondary Outcome Measure Information:
Title
Pain Catastrophizing
Description
Change in pain catastrophizing as measured by the Pain Catastrophizing Scale Scored 0-52, with higher scores indicating worse outcome.
Time Frame
8 weeks,6 month follow up
Title
Perceived Stress
Description
Change in perceived stress as measured by the Perceived Stress Scale Scored 0-40, with higher scores indicating worse outcome.
Time Frame
8 weeks,6 month follow up
Title
Mindfulness
Description
Change in mindfulness as measured by the Five Facets of Mindfulness Questionnaire short form Scored 24-120, with higher scores indicating better outcome.
Time Frame
8 weeks,6 month follow up
Title
Pain Intensity
Time Frame
8 weeks, 6 month follow up
Title
Sleep
Time Frame
8 weeks, 6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asimina Lazaridou, PhD
Phone
617-938-7810
Email
alazaridou@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kayvon Afsarifard
Email
kafsarifard@bwh.harvard.edu
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayvon Afsarifard

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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