Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers

Conditions
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Back Pain

Intervention / Treatment
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* Behavioral: Step count monitoring with consulting
* Behavioral: Step count monitoring without consultation
* Device: Fitbit tracker


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTIVITY TRACKER<br>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<br>* Subject counseled on step counts at initial visit and 2 and 4 weeks<br>Device: Fitbit tracker<br>* Fitbit tracker given to participant<br>|
| Placebo Comparator: Control<br>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. | Behavioral: Step count monitoring without consultation<br>* Subject counseled on step counts at initial visit<br>Device: Fitbit tracker<br>* Fitbit tracker given to participant<br>|

What is the study measuring?
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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 |