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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
Maryland University of Integrative Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring chronic pain, yoga, meditation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 22, 2021
    Last Updated
    February 24, 2021
    Sponsor
    Maryland University of Integrative Health
    Collaborators
    University of Maryland, College Park
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    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

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