Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers

Not Applicable

Terminated

• Conditions: Back Pain
• Interventions: Behavioral: Step count monitoring with consulting; Behavioral: Step count monitoring without consultation; Device: Fitbit tracker

• Registration Number: NCT03385083
• Lead Sponsor: New York Institute of Technology

Brief Summary

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.

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 Timeline

• Study Start: 2017-05-12
• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-26
• Study First Posted: 2017-12-28
• Status Verified: 2018-05
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACTIVITY TRACKER	Step count monitoring with consulting	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.
Control	Fitbit tracker	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.
ACTIVITY TRACKER	Fitbit 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.
Control	Step count monitoring without consultation	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.

Primary Outcome Measures

Name	Time	Method
Oswestry Low Back Pain Disability Questionnaire	6 weeks	Back pain assessment tool

Secondary Outcome Measures

Name	Time	Method
Step counts	6 weeks	Number of steps per day

Trial Locations

Locations (1)

NYIT; 🇺🇸 Old Westbury, New York, United States