NCT03040310

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

January 30, 2017

Last Update Submit

February 7, 2018

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index

    The Oswestry Disability Index is scored on a scale of 0-100, with a higher number representing more severe disability.

    Up to 12 months post-program start

Secondary Outcomes (4)

  • Compliance with app/program

    Up to 12 months post-program start

  • Satisfaction with program

    Up to 12 months post-program start

  • Medication utilization

    Up to 3 months post-program start

  • Pain score

    Up to 12 months post-program start

Study Arms (1)

Back Rx program

EXPERIMENTAL

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

Other: Back Rx program

Interventions

Back Rx programOTHER

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

Back Rx program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • to 65 years old
  • Computer literate; have smartphone (iPhone 5S or up, Android 2.3 or up)
  • English speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (2)

  • 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.

    PMID: 36261825DERIVED

  • 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.

    PMID: 30224333DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 2, 2017

Study Start

January 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

US(1)