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

NCT ID: NCT03040310

Last Updated: 2018-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Back Rx program

Study patients will use their smartphone apps to view their Back Rx program content, exercises, and videos.

Group Type EXPERIMENTAL

Back Rx program

Intervention Type OTHER

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

Interventions

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Back Rx program

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Cornell Tech

OTHER

Sponsor Role collaborator

UnitedHealth Group

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36261825 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30224333 (View on PubMed)

Other Identifiers

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2016-020

Identifier Type: -

Identifier Source: org_study_id

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