Clinical Trials Directory

Trials / Terminated

TerminatedNCT03385083

Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
2 (actual)
Sponsor
New York Institute of Technology · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStep count monitoring with consultingSubject counseled on step counts at initial visit and 2 and 4 weeks
BEHAVIORALStep count monitoring without consultationSubject counseled on step counts at initial visit
DEVICEFitbit trackerFitbit tracker given to participant

Timeline

Start date
2017-05-12
Primary completion
2018-05-01
Completion
2018-05-01
First posted
2017-12-28
Last updated
2018-05-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03385083. Inclusion in this directory is not an endorsement.