NCT02356783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 9, 2018

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

January 13, 2015

Results QC Date

February 5, 2018

Last Update Submit

October 2, 2019

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (2)

Interlaminar

OTHER

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

Transforaminal

OTHER

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

Interventions

PedometerDEVICE

Wireless pedometer

InterlaminarTransforaminal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital For Special Surgery

New York, New York, 10021, United States

Location

Related Publications (2)

  • 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.

    PMID: 23598728BACKGROUND

  • 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.

    PMID: 23110347BACKGROUND

Results Point of Contact

Title
Robert Griffin, MD, PhD
Organization
Hospital for Special Surgery
griffinr@hss.edu
212-774-2944

Study Officials

  • Robert Griffin, MD, PhD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

February 5, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

October 15, 2019

Results First Posted

April 9, 2018

Record last verified: 2019-10

Locations

US(1)