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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040310
• Other study ID #: 2016-020
• Status: Completed
• Phase: N/A
• First received: January 30, 2017
• Last updated: February 7, 2018
• Start date: January 2016
• Est. completion date: September 2017

Study information

• Verified date: February 2018
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Back Rx program
The Back Rx program can be viewed via a smartphone app.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Cornell Tech, UnitedHealth Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index	The Oswestry Disability Index is scored on a scale of 0-100, with a higher number representing more severe disability.	Up to 12 months post-program start
Secondary	Compliance with app/program	Measured via usage analytics by a composite index based on % of videos viewed and % of videos completed	Up to 12 months post-program start
Secondary	Satisfaction with program	Participants will be asked whether they would recommend the app to a friend.	Up to 12 months post-program start
Secondary	Medication utilization	Usage of medications will be documented	Up to 3 months post-program start
Secondary	Pain score	Pain will be assessed via the visual analog scale	Up to 12 months post-program start