CompletedNot Applicable

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

United States43 participantsStarted 2015-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Patients With Available Step Count Data at Baseline.

Timeframe: A week pre-procedure.

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

Timeframe: Duration of 60 days after procedure.

Trial details

NCT IDNCT02356783

SponsorHospital for Special Surgery, New York

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08

Results submitted2018-02-05

View on ClinicalTrials.gov More Chronic Low Back Pain trials