Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-12

Study Completion Date

2018-05-01

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.

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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.

Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Step count monitoring with consulting

Intervention Type BEHAVIORAL

Subject counseled on step counts at initial visit and 2 and 4 weeks

Fitbit tracker

Intervention Type DEVICE

Fitbit tracker given to participant

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.

Group Type PLACEBO_COMPARATOR

Step count monitoring without consultation

Intervention Type BEHAVIORAL

Subject counseled on step counts at initial visit

Fitbit tracker

Intervention Type DEVICE

Fitbit tracker given to participant

Interventions

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Step count monitoring with consulting

Subject counseled on step counts at initial visit and 2 and 4 weeks

Intervention Type BEHAVIORAL

Step count monitoring without consultation

Subject counseled on step counts at initial visit

Intervention Type BEHAVIORAL

Fitbit tracker

Fitbit tracker given to participant

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No