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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03040310
Enrollment
98
Registered
2017-02-02
Start date
2016-01-31
Completion date
2017-09-30
Last updated
2018-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

OTHERBack Rx program

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

Sponsors

Cornell Tech
CollaboratorOTHER
UnitedHealth Group
CollaboratorINDUSTRY
Hospital for Special Surgery, New York
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Oswestry Disability IndexUp to 12 months post-program startThe Oswestry Disability Index is scored on a scale of 0-100, with a higher number representing more severe disability.

Secondary

MeasureTime frameDescription
Compliance with app/programUp to 12 months post-program startMeasured via usage analytics by a composite index based on % of videos viewed and % of videos completed
Satisfaction with programUp to 12 months post-program startParticipants will be asked whether they would recommend the app to a friend.
Medication utilizationUp to 3 months post-program startUsage of medications will be documented
Pain scoreUp to 12 months post-program startPain will be assessed via the visual analog scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026