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

Not Applicable

Completed

• Conditions: Chronic Low Back Pain

• Registration Number: NCT02356783
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-13
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-05
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Results First Submitted: 2018-02-05
• Results First Submitted QC: 2018-03-12
• Results First Posted: 2018-04-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Available Step Count Data at Baseline.	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.	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.

Trial Locations

Locations (1)

Hospital For Special Surgery; 🇺🇸 New York, New York, United States