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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356783
• Other study ID #: #2014-135
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2019
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Pedometer
Wireless pedometer

Locations

Country	Name	City	State
United States	Hospital For Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Cohen, Steven P et al. 2013. "Epidural Steroids: A Comprehensive, Evidence-Based Review." Regional anesthesia and pain medicine 38(3): 175-200. http://www.ncbi.nlm.nih.gov/pubmed/23598728 (April 2, 2014).

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.