N/A N=33 Supportive Care

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

Chronic Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT02356783 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcome: Primary: Percentage of Patients With Available Step Count Data at Baseline. — 93.3; 71.4 percentage of patients with step data

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pedometer (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Available Step Count Data at Baseline.	93.3; 71.4	—
PRIMARY Percentage of Patients With Available Step Count Data Post-procedure.	73.3; 57.1	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02356783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.