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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post Epidural Steroid Injection Follow-up

NCT04207606

Lumbago Lumbar Spinal Stenosis Lumbar Disc Herniation

COMPLETED

A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections

NCT01053273

Low Back Pain

COMPLETED NA

the Evaluation of Four Non-operative Treatments for Degenerative Lumbar Spinal Stenosis

NCT02592642

Degenerative Lumbar Spinal Stenosis

COMPLETED NA

Transforaminal Epidural Steroid Injection With Pulsed Radiofrequency for Chronic Lumbosacral Radicular Pain Management

NCT02930057

Radicular; Neuropathic, Lumbar, Lumbosacral Low Back Pain Back Pain With Radiation

UNKNOWN PHASE4

Edge Computing Platform for Spine Health Risk Management Based on IoT Technology

NCT06092138

Cervical Disc Herniation Cervical Spinal Stenosis Ossification of Posterior Longitudinal Ligament +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Pedometer

Intervention Type DEVICE

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.

Group Type OTHER

Pedometer

Intervention Type DEVICE

Wireless pedometer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pedometer

Wireless pedometer

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No