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OpenTrials
Completed

NCT Number: NCT03040310

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Back Rx program

Other

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

Primary outcomes

  1. Oswestry Disability Index

    Time frame: Up to 12 months post-program start

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

Secondary outcomes

  1. Compliance with app/program

    Time frame: Up to 12 months post-program start

    Measured via usage analytics by a composite index based on % of videos viewed and % of videos completed

  2. Satisfaction with program

    Time frame: Up to 12 months post-program start

    Participants will be asked whether they would recommend the app to a friend.

  3. Medication utilization

    Time frame: Up to 3 months post-program start

    Usage of medications will be documented

  4. Pain score

    Time frame: Up to 12 months post-program start

    Pain will be assessed via the visual analog scale

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • Cornell Tech
  • UnitedHealth Group

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2017
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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