- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03040310
Personalized Back Rx Exercise Program as a Treatment for Discogenic Low Back Pain
February 7, 2018 updated by: Hospital for Special Surgery, New York
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10021
- Hospital for Special Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Back Rx program
Study patients will use their smartphone apps to view their Back Rx program content, exercises, and videos.
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The Back Rx program can be viewed via a smartphone app.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry Disability Index
Time Frame: Up to 12 months post-program start
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The Oswestry Disability Index is scored on a scale of 0-100, with a higher number representing more severe disability.
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Up to 12 months post-program start
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance with app/program
Time Frame: Up to 12 months post-program start
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Measured via usage analytics by a composite index based on % of videos viewed and % of videos completed
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Up to 12 months post-program start
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Satisfaction with program
Time Frame: Up to 12 months post-program start
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Participants will be asked whether they would recommend the app to a friend.
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Up to 12 months post-program start
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Medication utilization
Time Frame: Up to 3 months post-program start
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Usage of medications will be documented
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Up to 3 months post-program start
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Pain score
Time Frame: Up to 12 months post-program start
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Pain will be assessed via the visual analog scale
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Up to 12 months post-program start
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Vad VB, Madrazo-Ibarra A, Estrin D, Pollak JP, Carroll KM, Vojta D, Vad A, Trapness C. "Back Rx, a personalized mobile phone application for discogenic chronic low back pain: a prospective pilot study". BMC Musculoskelet Disord. 2022 Oct 19;23(1):923. doi: 10.1186/s12891-022-05883-9.
- Selter A, Tsangouri C, Ali SB, Freed D, Vatchinsky A, Kizer J, Sahuguet A, Vojta D, Vad V, Pollak JP, Estrin D. An mHealth App for Self-Management of Chronic Lower Back Pain (Limbr): Pilot Study. JMIR Mhealth Uhealth. 2018 Sep 17;6(9):e179. doi: 10.2196/mhealth.8256.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
January 30, 2017
First Submitted That Met QC Criteria
January 31, 2017
First Posted (Estimate)
February 2, 2017
Study Record Updates
Last Update Posted (Actual)
February 8, 2018
Last Update Submitted That Met QC Criteria
February 7, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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