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

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT03040310
• Collaborator: Cornell Tech (Other), UnitedHealth Group (Industry)
• Enrollment: 98
• Location: 1
• Arm: 1
• Actual Duration (Months): 20
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: Back Rx program	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Back Rx program Study patients will use their smartphone apps to view their Back Rx program content, exercises, and videos.	Other: Back Rx program; The Back Rx program can be viewed via a smartphone app.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Satisfaction with program [Up to 12 months post-program start]

   Participants will be asked whether they would recommend the app to a friend.

3. Medication utilization [Up to 3 months post-program start]

   Usage of medications will be documented

4. Pain score [Up to 12 months post-program start]

   Pain will be assessed via the visual analog scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York
• Cornell Tech
• UnitedHealth Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT03040310
• Other Study ID Numbers: 2016-020
• First Posted: Feb 2, 2017
• Last Update Posted: Feb 8, 2018
• Last Verified: Feb 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Feb 8, 2018