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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040310
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 8, 2018
Sponsor:
Collaborators:
Cornell Tech
UnitedHealth Group
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : January 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Compliance with app/program [ Time Frame: 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 [ Time Frame: Up to 12 months post-program start ]
    Participants will be asked whether they would recommend the app to a friend.

  3. Medication utilization [ Time Frame: Up to 3 months post-program start ]
    Usage of medications will be documented

  4. Pain score [ Time Frame: Up to 12 months post-program start ]
    Pain will be assessed via the visual analog scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040310


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Cornell Tech
UnitedHealth Group
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

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