Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Our aim is to assess usability and compliance of a wireless pedometer for monitoring step count after a lumbar epidural steroid injection for the treatment of radicular pain in low back pain patients. Our main hypothesis is to demonstrate pedometer measured step count can be used to measure efficacy of pain interventions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interlaminar | Other | Approach for lumbar epidural steroid injection for this arm will be interlaminar. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes. |
|
| Transforaminal | Other | Approach for lumbar epidural steroid injection for this arm will be transforaminal. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pedometer | Device | Wireless pedometer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Available Step Count Data at Baseline. | Percentage of patients with available step count data 7 days pre-procedure. Step count will be obtained daily for 7 days using a wireless pedometer. | A week pre-procedure. |
| Percentage of Patients With Available Step Count Data Post-procedure. | Percentage of patients with available step count data 60 days post-procedure. Step count will be obtained using a wireless pedometer daily for a period of 60 days post-procedure. | Duration of 60 days after procedure. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Griffin, MD, PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital For Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23598728 | Background | Cohen SP, Bicket MC, Jamison D, Wilkinson I, Rathmell JP. Epidural steroids: a comprehensive, evidence-based review. Reg Anesth Pain Med. 2013 May-Jun;38(3):175-200. doi: 10.1097/AAP.0b013e31828ea086. | |
| 23110347 | Background | MacVicar J, King W, Landers MH, Bogduk N. The effectiveness of lumbar transforaminal injection of steroids: a comprehensive review with systematic analysis of the published data. Pain Med. 2013 Jan;14(1):14-28. doi: 10.1111/j.1526-4637.2012.01508.x. Epub 2012 Oct 30. |
Not provided
Not provided
Forty-three patients were enrolled in study and received FitBit prior to their steroid injection appointment. Only 33 patients returned to have the steroid injection (16 interlaminar, 17 transforaminal). Three transforaminal and 1 interlaminar patient stopped using/syncing the FitBit, so data were not available to analyze.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Interlaminar | Approach for lumbar epidural steroid injection for this arm will be interlaminar. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes. Pedometer: Wireless pedometer |
| FG001 | Transforaminal | Approach for lumbar epidural steroid injection for this arm will be transforaminal. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes. Pedometer: Wireless pedometer |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Interlaminar | Approach for lumbar epidural steroid injection for this arm will be interlaminar. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes. Pedometer: Wireless pedometer |
| BG001 | Transforaminal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Available Step Count Data at Baseline. | Percentage of patients with available step count data 7 days pre-procedure. Step count will be obtained daily for 7 days using a wireless pedometer. | Posted | Number | percentage of patients with step data | A week pre-procedure. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interlaminar | Approach for lumbar epidural steroid injection for this arm will be interlaminar. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes. Pedometer: Wireless pedometer |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Griffin, MD, PhD | Hospital for Special Surgery | 212-774-2944 | griffinr@hss.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Approach for lumbar epidural steroid injection for this arm will be transforaminal. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes. Pedometer: Wireless pedometer |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Patients With Available Step Count Data Post-procedure. | Percentage of patients with available step count data 60 days post-procedure. Step count will be obtained using a wireless pedometer daily for a period of 60 days post-procedure. | Posted | Number | percentage of patients with step data | Duration of 60 days after procedure. |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Transforaminal | Approach for lumbar epidural steroid injection for this arm will be transforaminal. We will be implementing a wireless pedometer to each of the 15 patients in this group to measure our primary and secondary outcomes. Pedometer: Wireless pedometer | 0 | 14 | 0 | 14 |
Not provided
Not provided
Not provided