Clinical trial NCT03040310: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Cornell Tech
name: UnitedHealth Group
First posted: 2017-02-02
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: Up to 12 months post-program start
Secondary outcomes:
measure: Compliance with app/program
timeFrame: Up to 12 months post-program start
measure: Satisfaction with program
timeFrame: Up to 12 months post-program start
measure: Medication utilization
timeFrame: Up to 3 months post-program start
measure: Pain score
timeFrame: Up to 12 months post-program start
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
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.
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.