Back to resultsPersonalized Back Rx Exercise Program as a Treatment for Discogenic Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Back Rx program
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility 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
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Back Rx program
Arm Description
Study patients will use their smartphone apps to view their Back Rx program content, exercises, and videos.
Outcomes
Primary Outcome Measures
Oswestry Disability Index
The Oswestry Disability Index is scored on a scale of 0-100, with a higher number representing more severe disability.
Secondary Outcome Measures
Compliance with app/program
Measured via usage analytics by a composite index based on % of videos viewed and % of videos completed
Satisfaction with program
Participants will be asked whether they would recommend the app to a friend.
Medication utilization
Usage of medications will be documented
Pain score
Pain will be assessed via the visual analog scale
Full Information
NCT ID
NCT03040310
First Posted
January 30, 2017
Last Updated
February 7, 2018
Sponsor
Hospital for Special Surgery, New York
Collaborators
Cornell Tech, UnitedHealth Group
1. Study Identification
Unique Protocol Identification Number
NCT03040310
Brief Title
Personalized Back Rx Exercise Program as a Treatment for Discogenic Low Back Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
Cornell Tech, UnitedHealth Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Back Rx program
Arm Type
Experimental
Arm Description
Study patients will use their smartphone apps to view their Back Rx program content, exercises, and videos.
Intervention Type
Other
Intervention Name(s)
Back Rx program
Intervention Description
The Back Rx program can be viewed via a smartphone app.
Primary Outcome Measure Information:
Title
Oswestry Disability Index
Description
The Oswestry Disability Index is scored on a scale of 0-100, with a higher number representing more severe disability.
Time Frame
Up to 12 months post-program start
Secondary Outcome Measure Information:
Title
Compliance with app/program
Description
Measured via usage analytics by a composite index based on % of videos viewed and % of videos completed
Time Frame
Up to 12 months post-program start
Title
Satisfaction with program
Description
Participants will be asked whether they would recommend the app to a friend.
Time Frame
Up to 12 months post-program start
Title
Medication utilization
Description
Usage of medications will be documented
Time Frame
Up to 3 months post-program start
Title
Pain score
Description
Pain will be assessed via the visual analog scale
Time Frame
Up to 12 months post-program start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36261825
Citation
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.
Results Reference
derived
PubMed Identifier
30224333
Citation
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.
Results Reference
derived
Learn more about this trial
Personalized Back Rx Exercise Program as a Treatment for Discogenic Low Back Pain
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