Burst Neurostimulation for Discogenic Low Back Pain

Status Active, not recruiting

Clinical Trial Summary

The purpose of this prospective post market pilot study is to evaluate the effect of Burst Spinal Cord Stimulation(B-SCS) in the management of chronic discogenic pain in subjects who are refractory to other available treatments. Selected subjects will not be suitable candidates for lumbar spinal surgery and will meet the standard selection process for SCS as routinely utilized in the study centers. Results from this pilot study will inform current clinical practice and future comparative studies in this specific population. Eligible subjects for B-SCS will be asked to participate in this study. If they decide to participate, they will be treated with the Prodigy TM and Proclaim TM (Abbott Laboratories) SCS system and prospectively followed for 12 months following implantation.

Clinical Trial Description

This is a prospective, single-arm, single-center, post-market, pilot study to collect data on back pain relief, subject satisfaction, quality of life, physical functioning and safety. Chronic discogenic pain(CDP) suffering patients will be followed for 12 months with follow-up visits at 3, 6, and 12 months. In line with standard practice the system will be implanted in two stages. The first stage is the Trial Burst spinal cord Neurostimulation (TBNS) phase during which epidural leads are implanted and temporarily tunnelled to an external trial stimulation device. Subjects will then utilize the temporary system for a period in line with usual practice (typically 10-14 days). If, at the end of this TBNS phase a reduction of ≥50% is achieved the device will be permanently implanted (the second stage) and subjects will be followed-up during 12 months. Patients who do not have at least 50% pain relief during TBNS will receive a Trial Tonic Neurostimulator(TTNS) targeting the dorsal root ganglion(DRG). Similarly, these patients will be followed-up during 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03958604
Study type	Interventional
Source	Rijnstate Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	May 28, 2019
Completion date	December 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03916705` - Thoraco-Lumbar Fascia Mobility	N/A
Completed	`NCT04007302` - Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago	N/A
Completed	`NCT03273114` - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain	N/A
Recruiting	`NCT03600207` - The Effect of Diaphragm Muscle Training on Chronic Low Back Pain	N/A
Completed	`NCT04284982` - Periodized Resistance Training for Persistent Non-specific Low Back Pain	N/A
Recruiting	`NCT05600543` - Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain	N/A
Withdrawn	`NCT05410366` - Safe Harbors in Emergency Medicine, Specific Aim 3
Completed	`NCT03673436` - Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
Completed	`NCT02546466` - Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain	N/A
Completed	`NCT00983385` - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics	Phase 3
Recruiting	`NCT05156242` - Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain.	N/A
Recruiting	`NCT04673773` - MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain.	N/A
Completed	`NCT06049251` - ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises	N/A
Completed	`NCT06049277` - Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain	N/A
Completed	`NCT04980469` - A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle	N/A
Completed	`NCT04055545` - High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects	N/A
Recruiting	`NCT05944354` - Wearable Spine Health System for Military Readiness
Recruiting	`NCT05552248` - Assessment of the Safety and Performance of a Lumbar Belt
Completed	`NCT05801588` - Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life	N/A
Completed	`NCT05811143` - Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.