Remotely Delivered Yoga Program for Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring chronic pain, yoga, meditation
Eligibility Criteria
Inclusion Criteria:
Adults age 18-64 years who report chronic nonspecific low back pain, defined as low back pain of unknown etiology persisting for at least 12 weeks,
- Participants must report an average pain intensity in the previous week of 4 or greater on an 11-point (0 to 10) numerical rating scale,
- Demonstrate medium to high risk on the STarT back screening tool,
- Understand English
- Have access to technology including a computer and internet access
Exclusion Criteria:
Specific causes of low back pain (e.g. spinal fractures, cancer-related pain)
- Severe or progressive neurological deficits
- Severe chronic medical and/or psychiatric comorbidities that may prevent safe participation in the study
- Established pregnancy
- Current yoga practice or regular yoga class attendance in the last three months;
- Current application for a receipt of workers compensation
- lack of access to technology including a computer and the internet
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chronic nonspecific low back pain
Arm Description
Remotely delivered yoga intervention
Outcomes
Primary Outcome Measures
Change in Oswestry Disability Index
Back related function and pain
Secondary Outcome Measures
Change in Vagal Efficiency
A device will be used to measure Heart rate variability and vagal efficiency
Change in Purpose in Life
Six item measure of purpose in life
Change in Body Brain Center Sensory Scales
Subjective measure of sensory sensitivity
Change in Body Perception Questionnaire subscale on autonomic reactivity
Subjective measure of autonomic reactivity
Full Information
NCT ID
NCT04773743
First Posted
January 22, 2021
Last Updated
February 24, 2021
Sponsor
Maryland University of Integrative Health
Collaborators
University of Maryland, College Park
1. Study Identification
Unique Protocol Identification Number
NCT04773743
Brief Title
Remotely Delivered Yoga Program for Chronic Low Back Pain
Official Title
Feasibility of a Remotely Delivered Yoga Intervention for Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2021 (Anticipated)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maryland University of Integrative Health
Collaborators
University of Maryland, College Park
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
The purpose of this research is to integrate the meditative components of integrative restoration (iRest) yoga nidra with simple and safe movement sequences derived from established yoga postures and physical therapy interventions for chronic nonspecific low back pain and to use telemedicine technology to facilitate the intervention in a diverse socioeconomic and racial/ethnic population. This project will first systematically adapt the iRest yoga intervention for the incorporation of movement using a consultative and iterative process followed by a pilot intervention to assess the acceptability and preliminary efficacy of this program for pain, back related function and to address body-mind regulation and biopsychosocial-spiritual well-being. Hypothesis: a yoga intervention emphasizing meditative movement and relaxation will be safe for remote delivery and effective for biopsychosocial-spiritual outcomes for people with chronic low back pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
chronic pain, yoga, meditation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chronic nonspecific low back pain
Arm Type
Experimental
Arm Description
Remotely delivered yoga intervention
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
Remotely delivered yoga intervention
Primary Outcome Measure Information:
Title
Change in Oswestry Disability Index
Description
Back related function and pain
Time Frame
Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
Secondary Outcome Measure Information:
Title
Change in Vagal Efficiency
Description
A device will be used to measure Heart rate variability and vagal efficiency
Time Frame
Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
Title
Change in Purpose in Life
Description
Six item measure of purpose in life
Time Frame
Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
Title
Change in Body Brain Center Sensory Scales
Description
Subjective measure of sensory sensitivity
Time Frame
Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
Title
Change in Body Perception Questionnaire subscale on autonomic reactivity
Description
Subjective measure of autonomic reactivity
Time Frame
Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults age 18-64 years who report chronic nonspecific low back pain, defined as low back pain of unknown etiology persisting for at least 12 weeks,
Participants must report an average pain intensity in the previous week of 4 or greater on an 11-point (0 to 10) numerical rating scale,
Demonstrate medium to high risk on the STarT back screening tool,
Understand English
Have access to technology including a computer and internet access
Exclusion Criteria:
Specific causes of low back pain (e.g. spinal fractures, cancer-related pain)
Severe or progressive neurological deficits
Severe chronic medical and/or psychiatric comorbidities that may prevent safe participation in the study
Established pregnancy
Current yoga practice or regular yoga class attendance in the last three months;
Current application for a receipt of workers compensation
lack of access to technology including a computer and the internet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marlysa Sullivan, MPT
Phone
4108889048
Email
msullivan1@muih.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlysa Sullivan, MPT
Organizational Affiliation
Maryland University of Integrative Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data
Learn more about this trial
Remotely Delivered Yoga Program for Chronic Low Back Pain
We'll reach out to this number within 24 hrs