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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03385083
Other study ID # BHS-1292
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 12, 2017
Est. completion date May 1, 2018

Study information

Verified date May 2018
Source New York Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date May 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Step count monitoring with consulting
Subject counseled on step counts at initial visit and 2 and 4 weeks
Step count monitoring without consultation
Subject counseled on step counts at initial visit
Device:
Fitbit tracker
Fitbit tracker given to participant

Locations

Country Name City State
United States NYIT Old Westbury New York

Sponsors (1)

Lead Sponsor Collaborator
New York Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oswestry Low Back Pain Disability Questionnaire Back pain assessment tool 6 weeks
Secondary Step counts Number of steps per day 6 weeks
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