Trial Outcomes & Findings for Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain (NCT NCT02356783)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

A week pre-procedure.

Results posted on

2019-10-15

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	16	17
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Implementation of Pedometer for Monitoring Step Count Pre and Post Lumbar ESI for Radicular Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interlaminar n=15 Participants 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	Transforaminal n=14 Participants 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	Total n=29 Participants Total of all reporting groups
Age, Continuous	54.9 years STANDARD_DEVIATION 16.2 • n=5 Participants	51.5 years STANDARD_DEVIATION 12.9 • n=7 Participants	53.3 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Interlaminar n=15 Participants 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	Transforaminal n=14 Participants 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
Percentage of Patients With Available Step Count Data at Baseline.	93.3 percentage of patients with step data	71.4 percentage of patients with step data

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Interlaminar n=15 Participants 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	Transforaminal n=14 Participants 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
Percentage of Patients With Available Step Count Data Post-procedure.	73.3 percentage of patients with step data	57.1 percentage of patients with step data

Adverse Events

Interlaminar

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Transforaminal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Griffin, MD, PhD

Hospital for Special Surgery

Phone: 212-774-2944

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place