Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers

This is a randomized controlled study to assess the effects of activity monitors, with telehealth follow ups, on the treatment of chronic low back pain subjects.

Study Overview

• Status: Terminated
• Conditions: Back Pain
• Intervention / Treatment: Behavioral: Step count monitoring with consulting; Device: Fitbit tracker; Behavioral: Step count monitoring without consultation

Detailed Description

This is a randomized controlled study to assess the effects of activity monitors, with telehealth follow ups, on the treatment of chronic low back pain subjects. Subjects with low back pain will present for evaluation to the NYIT Academic Health Care Center. Once serious complications have been ruled out and a diagnosis of chronic low back pain has been made, subjects will be informed about this proposed study and asked if they would like to participate. Voluntary subjects will then be consented by designated investigators. The subjects will then be randomized into either the activity tracker and telemedicine follow up group or the control group.

Once enrolled, all subjects will complete the study as outlined in the procedures. It will involve the use of several validated assessment tools. Following the initial visit, subjects in both groups will return in 6 weeks for reassessment. Subjects in the experimental group will additionally be given an activity tracker and have 2 telemedicine visits at 2 and 4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Old Westbury, New York, United States, 11568
      • NYIT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is at least 18 years age and younger than 75 years of age
• Subjects evaluated and found to have low back lasting longer than 3 months

Exclusion Criteria:

The subject suffers from any of the following:

• Foot drop
• Recent diagnosis of malignancy
• Recent infection
• Saddle anesthesia
• Urinary or bowel incontinence

• Progressive neuromotor or sensory loss

  • The subject is unable to complete the assessment tools
  • The subject is pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACTIVITY TRACKER; Subjects in Cohort A will receive standard of care treatments in addition to a Fitbit Flex 2 activity tracker for six weeks and recommendation for daily step counts at initial visit. Cohort A will then meet with researchers via telehealth at 2 weeks and 4 weeks with researchers to review step counts and reaffirm targets. Subjects in Cohorts A will be reassessed in person at the conclusion of the six week period.	Behavioral: Step count monitoring with consulting; Subject counseled on step counts at initial visit and 2 and 4 weeks; Device: Fitbit tracker; Fitbit tracker given to participant
Placebo Comparator: Control; Subjects in Cohort B will receive standard of care treatments in addition to a Fitbit Flex 2 activity tracker for six weeks and recommendation for daily step counts at initial visit. Subjects in Cohorts B will be reassessed in person at the conclusion of the six week period.	Device: Fitbit tracker; Fitbit tracker given to participant; Behavioral: Step count monitoring without consultation; Subject counseled on step counts at initial visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Low Back Pain Disability Questionnaire	Back pain assessment tool	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step counts	Number of steps per day	6 weeks

Collaborators and Investigators

• Sponsor: New York Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 26, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: BHS-1292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Shared upon request
• IPD Sharing Time Frame: 1 year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No