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IRB approval lapsed
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Step count monitoring with consulting | Behavioral | Subject counseled on step counts at initial visit and 2 and 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Low Back Pain Disability Questionnaire | Back pain assessment tool | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Step counts | Number of steps per day | 6 weeks |
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Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYIT | Old Westbury | New York | 11568 | United States |
Shared upon request
1 year
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Step count monitoring without consultation | Behavioral | Subject counseled on step counts at initial visit |
|
| Fitbit tracker | Device | Fitbit tracker given to participant |
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