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Clinical Trials/NCT02356783
NCT02356783
Completed
Not Applicable

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

Hospital for Special Surgery, New York1 site in 1 country43 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
Hospital for Special Surgery, New York
Enrollment
43
Locations
1
Primary Endpoint
Percentage of Patients With Available Step Count Data at Baseline.
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
September 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital for Special Surgery, New York
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

Study Sites (1)

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