Remotely Delivered Yoga Program for Chronic Low Back Pain

Overview

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.

Full Title of Study: “Feasibility of a Remotely Delivered Yoga Intervention for Chronic Low Back Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 30, 2021

Interventions

  • Other: Yoga
    • Remotely delivered yoga intervention

Arms, Groups and Cohorts

  • Experimental: chronic nonspecific low back pain
    • Remotely delivered yoga intervention

Clinical Trial Outcome Measures

Primary Measures

  • Change in Oswestry Disability Index
    • Time Frame: Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
    • Back related function and pain

Secondary Measures

  • Change in Vagal Efficiency
    • Time Frame: Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
    • A device will be used to measure Heart rate variability and vagal efficiency
  • Change in Purpose in Life
    • Time Frame: Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
    • Six item measure of purpose in life
  • Change in Body Brain Center Sensory Scales
    • Time Frame: Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
    • Subjective measure of sensory sensitivity
  • Change in Body Perception Questionnaire subscale on autonomic reactivity
    • Time Frame: Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
    • Subjective measure of autonomic reactivity

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maryland University of Integrative Health
  • Collaborator
    • University of Maryland, College Park
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marlysa Sullivan, MPT, Principal Investigator, Maryland University of Integrative Health
  • Overall Contact(s)
    • Marlysa Sullivan, MPT, 4108889048, msullivan1@muih.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.