Personalized Back Rx Exercise Program as a Treatment for Discogenic Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Back Rx program

• Registration Number: NCT03040310
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-02
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Back Rx program	Back Rx program	Study patients will use their smartphone apps to view their Back Rx program content, exercises, and videos.

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	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 Outcome Measures

Name	Time	Method
Medication utilization	Up to 3 months post-program start	Usage of medications will be documented
Compliance with app/program	Up to 12 months post-program start	Measured via usage analytics by a composite index based on % of videos viewed and % of videos completed
Satisfaction with program	Up to 12 months post-program start	Participants will be asked whether they would recommend the app to a friend.
Pain score	Up to 12 months post-program start	Pain will be assessed via the visual analog scale

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States