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

Study Overview
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Brief Summary
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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.

Official Title
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Implementation of Wireless Pedometer for Monitoring Step Count Before and After Lumbar Epidural Steroid Injection for Radicular Pain.

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Device: Pedometer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Interlaminar<br>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. | Device: Pedometer<br>* Wireless pedometer<br>|
| Other: Transforaminal<br>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. | Device: Pedometer<br>* Wireless pedometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Available Step Count Data at Baseline. | 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. | 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. |