Clinical Outcomes in Chronic Low Pain Back Utilizing Activity Trackers

NCT03385083 | Terminated

• 1 other identifier: BHS-1292
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

• Oswestry Low Back Pain Disability Questionnaire

  Back pain assessment tool

  6 weeks

Secondary Outcomes (1)

• Step counts

  6 weeks

Study Arms (2)

ACTIVITY TRACKER

EXPERIMENTAL

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.

Behavioral: Step count monitoring with consulting; Device: Fitbit tracker

Control

PLACEBO COMPARATOR

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.

Behavioral: Step count monitoring without consultation; Device: Fitbit tracker

Interventions

Step count monitoring with consulting BEHAVIORAL

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

ACTIVITY TRACKER

Step count monitoring without consultation BEHAVIORAL

Subject counseled on step counts at initial visit

Control

Fitbit tracker DEVICE

Fitbit tracker given to participant

ACTIVITY TRACKER; Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Institute of Technology: lead

Study Sites (1)

NYIT

Old Westbury, New York, 11568, United States

Location

MeSH Terms

Conditions

Back Pain

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: May 12, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 7, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year

Locations

US (1)