Remotely Delivered Yoga Program for Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Feasibility of a Remotely Delivered Yoga Intervention for Chronic Low Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04773743
• Other study ID #: 07.SUL.10.20.2
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: February 2021
• Source: Maryland University of Integrative Health
• Contact: Marlysa Sullivan, MPT
• Phone: 4108889048
• Email: msullivan1[@]muih.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Yoga
Remotely delivered yoga intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maryland University of Integrative Health	University of Maryland, College Park

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oswestry Disability Index	Back related function and pain	Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
Secondary	Change in Vagal Efficiency	A device will be used to measure Heart rate variability and vagal efficiency	Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
Secondary	Change in Purpose in Life	Six item measure of purpose in life	Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
Secondary	Change in Body Brain Center Sensory Scales	Subjective measure of sensory sensitivity	Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
Secondary	Change in Body Perception Questionnaire subscale on autonomic reactivity	Subjective measure of autonomic reactivity	Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up