Clinical trial NCT04773743: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: chronic pain
yoga
meditation
Lead sponsor: Maryland University of Integrative Health
Sponsor class: OTHER
Collaborators: name: University of Maryland, College Park
First posted: 2021-02-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Oswestry Disability Index
timeFrame: Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
Secondary outcomes:
measure: Change in Vagal Efficiency
timeFrame: Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
measure: Change in Purpose in Life
timeFrame: Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
measure: Change in Body Brain Center Sensory Scales
timeFrame: Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
measure: Change in Body Perception Questionnaire subscale on autonomic reactivity
timeFrame: Pre, midpoint (4 weeks), final (8 weeks), 1 month follow up
Other outcomes:
Locations:
Study officials:
affiliation: Maryland University of Integrative Health
name: Marlysa Sullivan, MPT
role: PRINCIPAL_INVESTIGATOR
References: