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

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ClinicalTrials.gov Identifier: NCT02356783
Recruitment Status : Completed
First Posted : February 5, 2015
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: Pedometer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Implementation of Wireless Pedometer for Monitoring Step Count Before and After Lumbar Epidural Steroid Injection for Radicular Pain.
Study Start Date : February 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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.

Device: Pedometer
Wireless pedometer

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.

Device: Pedometer
Wireless pedometer




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356783


Locations
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United States, New York
Hospital For Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Robert Griffin, MD, PhD Hospital for Special Surgery, New York

Publications:
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).

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02356783     History of Changes
Other Study ID Numbers: #2014-135
First Posted: February 5, 2015    Key Record Dates
Results First Posted: April 9, 2018
Last Update Posted: April 9, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms