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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pedometer
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital For Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Interlaminar

Transforaminal

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2015
Last Updated
October 2, 2019
Sponsor
Hospital for Special Surgery, New York
Collaborators
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02356783
Brief Title
Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain
Official Title
Implementation of Wireless Pedometer for Monitoring Step Count Before and After Lumbar Epidural Steroid Injection for Radicular Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
Memorial Sloan Kettering Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interlaminar
Arm Type
Other
Arm Description
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.
Arm Title
Transforaminal
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pedometer
Intervention Description
Wireless pedometer
Primary Outcome Measure Information:
Title
Percentage of Patients With Available Step Count Data at Baseline.
Description
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.
Time Frame
A week pre-procedure.
Title
Percentage of Patients With Available Step Count Data Post-procedure.
Description
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.
Time Frame
Duration of 60 days after procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Griffin, MD, PhD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital For Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23598728
Citation
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.
Results Reference
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PubMed Identifier
23110347
Citation
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.
Results Reference
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Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain

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