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OpenTrials
Completed

NCT Number: NCT02356783

Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain

Our aim is to assess usability and compliance of a wireless pedometer for monitoring step count after a lumbar epidural steroid injection for the treatment of radicular pain in low back pain patients. Our main hypothesis is to demonstrate pedometer measured step count can be used to measure efficacy of pain interventions.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year and older

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

  • 18 years of age and older
  • Patients receiving lumbar epidural steroid injections as pain management to be scheduled at least one week away (-2 days/1 month).
  • Patients who are able to understand how the Fitbit instrument works and are willing to consent to the study.
  • Patient who used web-based communication frequently, e.g. Email.
  • Patients who can speak, understand, and write in English.
  • Prior MRI or an appointment to obtain an MRI prior to the procedure.

Exclusion criteria

  • Workers' compensation cases.
  • Patient does not have a computer at home.
  • Non-ambulatory patients.
  • Patients who have received a lumbar epidural steroid injection in the past 6 months.
  • Nursing or pregnant women.

Treatment and study plan

Pedometer

Device

Wireless pedometer

Primary outcomes

  1. Percentage of Patients With Available Step Count Data at Baseline.

    Time frame: A week pre-procedure.

    Percentage of patients with available step count data 7 days pre-procedure. Step count will be obtained daily for 7 days using a wireless pedometer.

  2. Percentage of Patients With Available Step Count Data Post-procedure.

    Time frame: Duration of 60 days after procedure.

    Percentage of patients with available step count data 60 days post-procedure. Step count will be obtained using a wireless pedometer daily for a period of 60 days post-procedure.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • Memorial Sloan Kettering Cancer Center

Registry information

Official study title

Implementation of Wireless Pedometer for Monitoring Step Count Before and After Lumbar Epidural Steroid Injection for Radicular Pain.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2015
Registry last updated
Oct 15, 2019

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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