- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02356783
Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain
Implementation of Wireless Pedometer for Monitoring Step Count Before and After Lumbar Epidural Steroid Injection for Radicular Pain.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Hospital for Special Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Interlaminar
Approach for lumbar epidural steroid injection for this arm will be interlaminar. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes. |
Wireless pedometer
|
Other: Transforaminal
Approach for lumbar epidural steroid injection for this arm will be transforaminal. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes. |
Wireless pedometer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
A week pre-procedure.
|
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.
|
Duration of 60 days after procedure.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert Griffin, MD, PhD, Hospital for Special Surgery, New York
Publications and helpful links
General Publications
- Cohen SP, Bicket MC, Jamison D, Wilkinson I, Rathmell JP. Epidural steroids: a comprehensive, evidence-based review. Reg Anesth Pain Med. 2013 May-Jun;38(3):175-200. doi: 10.1097/AAP.0b013e31828ea086.
- MacVicar J, King W, Landers MH, Bogduk N. The effectiveness of lumbar transforaminal injection of steroids: a comprehensive review with systematic analysis of the published data. Pain Med. 2013 Jan;14(1):14-28. doi: 10.1111/j.1526-4637.2012.01508.x. Epub 2012 Oct 30.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #2014-135
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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