Chronic Low Back Pain
Conditions
Brief summary
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.
Interventions
DEVICEPedometer
Wireless pedometer
Sponsors
Memorial Sloan Kettering Cancer Center
Hospital for Special Surgery, New York
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age and older * Patients receiving lumbar epidural steroid injections as pain management to be scheduled at least one week away (-2 days/1 month). * Patients who are able to understand how the Fitbit instrument works and are willing to consent to the study. * Patient who used web-based communication frequently, e.g. Email. * Patients who can speak, understand, and write in English. * Prior MRI or an appointment to obtain an MRI prior to the procedure.
Exclusion criteria
* Workers' compensation cases. * Patient does not have a computer at home. * Non-ambulatory patients. * Patients who have received a lumbar epidural steroid injection in the past 6 months. * Nursing or pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Available Step Count Data at Baseline. | A week pre-procedure. | 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. |
| Percentage of Patients With Available Step Count Data Post-procedure. | Duration of 60 days after 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 14 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Interlaminar | Transforaminal | Total |
|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 16.2 | 51.5 years STANDARD_DEVIATION 12.9 | 53.3 years STANDARD_DEVIATION 14.5 |
| Region of Enrollment United States | 15 Participants | 14 Participants | 29 Participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
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.
Time frame: A week pre-procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interlaminar | Percentage of Patients With Available Step Count Data at Baseline. | 93.3 percentage of patients with step data |
| Transforaminal | Percentage of Patients With Available Step Count Data at Baseline. | 71.4 percentage of patients with step data |
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.
Time frame: Duration of 60 days after procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interlaminar | Percentage of Patients With Available Step Count Data Post-procedure. | 73.3 percentage of patients with step data |
| Transforaminal | Percentage of Patients With Available Step Count Data Post-procedure. | 57.1 percentage of patients with step data |