Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers

New York Institute of Technology

Status: Terminated

Conditions: Back Pain

Treatments: Device: Fitbit tracker; Behavioral: Step count monitoring with consulting; Behavioral: Step count monitoring without consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT03385083

BHS-1292

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups, including a placebo group

ACTIVITY TRACKER

Experimental group

Description:

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.

Treatment:

Device: Fitbit tracker

Behavioral: Step count monitoring with consulting

Control

Placebo Comparator group

Description:

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.

Treatment:

Device: Fitbit tracker

Behavioral: Step count monitoring without consultation