Remotely Delivered Yoga Program for Chronic Low Back Pain

Not Applicable

• Conditions: Low Back Pain
• Interventions: Other: Yoga

• Registration Number: NCT04773743
• Lead Sponsor: Maryland University of Integrative Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-22
• Status Verified: 2021-02
• Study Start: 2021-02-15
• Study First Submitted QC: 2021-02-24
• Last Update Submitted: 2021-02-24
• Study First Posted: 2021-02-26
• Last Update Posted: 2021-02-26
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chronic nonspecific low back pain	Yoga	Remotely delivered yoga intervention

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Vagal Efficiency	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	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	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	Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up	Subjective measure of autonomic reactivity