Back Pain
Conditions
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.
Interventions
BEHAVIORALStep count monitoring with consulting
Subject counseled on step counts at initial visit and 2 and 4 weeks
BEHAVIORALStep count monitoring without consultation
Subject counseled on step counts at initial visit
DEVICEFitbit tracker
Fitbit tracker given to participant
Sponsors
New York Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Low Back Pain Disability Questionnaire | 6 weeks | Back pain assessment tool |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Step counts | 6 weeks | Number of steps per day |
Countries
United States
Outcome results
None listed