search
Back to results

Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers

Primary Purpose

Back Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Step count monitoring with consulting
Step count monitoring without consultation
Fitbit tracker
Sponsored by
New York Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NYIT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ACTIVITY TRACKER

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Oswestry Low Back Pain Disability Questionnaire
Back pain assessment tool

Secondary Outcome Measures

Step counts
Number of steps per day

Full Information

First Posted
December 20, 2017
Last Updated
May 2, 2018
Sponsor
New York Institute of Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT03385083
Brief Title
Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers
Official Title
Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
IRB approval lapsed
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACTIVITY TRACKER
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Step count monitoring with consulting
Intervention Description
Subject counseled on step counts at initial visit and 2 and 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
Step count monitoring without consultation
Intervention Description
Subject counseled on step counts at initial visit
Intervention Type
Device
Intervention Name(s)
Fitbit tracker
Intervention Description
Fitbit tracker given to participant
Primary Outcome Measure Information:
Title
Oswestry Low Back Pain Disability Questionnaire
Description
Back pain assessment tool
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Step counts
Description
Number of steps per day
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
NYIT
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Shared upon request
IPD Sharing Time Frame
1 year

Learn more about this trial

Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers

We'll reach out to this number within 24 hrs