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Clinical Trials/NCT03040310
NCT03040310
Completed
Not Applicable

Personalized Back Rx Exercise Program With Coaching, Social Support, and Sensor-assisted Assessments as a Treatment for Discogenic Low Back Pain: A Prospective Pilot Study

Hospital for Special Surgery, New York1 site in 1 country98 target enrollmentJanuary 2016
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Hospital for Special Surgery, New York
Enrollment
98
Locations
1
Primary Endpoint
Oswestry Disability Index
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The prevalence and disability associated with discogenic low back pain are significant, and there is a general lack of widely accepted conservative treatments for the condition. A majority of previous studies that have assessed the efficacy of self-directed exercise-based rehabilitation programs did not include comprehensive metrics to confirm whether participants actually participated in the exercises prescribed. In this pilot study, the investigators hope to determine whether proxies of compliance with a daily, self-directed rehabilitation program for discogenic low back pain are correlated with participant-reported improvements in pain and function. The feasibility of a mobile interface designed to help patients with chronic low back pain track the daily management of their conditions will also be evaluated.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
September 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hospital for Special Surgery, New York
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Low back pain with predominantly axial symptoms (axial pain \> leg pain) that are exacerbated with sitting and alleviated with walking
  • Persistence of symptoms for at least 3 months
  • Lumbar intervertebral disc pathology evident on magnetic resonance imaging
  • 18 to 65 years old
  • Computer literate; have smartphone (iPhone 5S or up, Android 2.3 or up)
  • English speaking

Exclusion Criteria

  • Concurrent pathology that may contribute to patients' axial low back symptoms (e.g., spondylolysis, spondylolisthesis, facet arthropathy)
  • Severe lumbar disc degeneration prior to beginning Back Rx exercise program
  • History of lumbar spine surgery or other interventions prior to beginning Back Rx exercise program
  • History of trauma
  • Cases involving workers' compensation or other legal claims
  • Non-English speaking

Outcomes

Primary Outcomes

Oswestry Disability Index

Time Frame: Up to 12 months post-program start

The Oswestry Disability Index is scored on a scale of 0-100, with a higher number representing more severe disability.

Secondary Outcomes

  • Medication utilization(Up to 3 months post-program start)
  • Compliance with app/program(Up to 12 months post-program start)
  • Satisfaction with program(Up to 12 months post-program start)
  • Pain score(Up to 12 months post-program start)

Study Sites (1)

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