N/A
Completed N=33
Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain
Source: ClinicalTrials.gov NCT02356783 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Percentage of Patients With Available Step Count Data at Baseline. — 93.3; 71.4 percentage of patients with step data
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.
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 | — |
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.
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. Informational only — not medical advice.