Chronic Pain Clinical Trial
Official title:
Effectiveness of the Precision Spinal Cord Stimulation System With the Artisan Paddle Electrode in Patients With Back or Lower Extremity Pain
The primary objective of this study is to evaluate the acute and chronic efficacy of spinal cord stimulation using the Precision implantable neurostimulation device with the Artisan paddle electrode in patients with Failed Back Surgery Syndrome (FBSS) and associated primary or secondary back or lower extremity pain. There are significant numbers of patients with FBSS who have moderate to severe drug refractory pain. An optimal outcome will demonstrate that the Precision SCS device has significant effectiveness in reducing this pain resulting in improved quality of life and functional capacity.
The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed in parallel at T8-T9 vertebral levels. A common problem after surgery is the migration of leads from the initial implanted site, the consequence of which is inadequate pain relief. Anecdotal reports suggest that the paddle electrode can eliminate some of the problems associated with lead migration by providing a constant distance between the parallel electrodes. Furthermore, it has been reported to provide superior pain relief and paresthesia coverage. This study aims to evaluate pain and paresthesia coverage by placing a paddle lead. Patients invited to participate in this study will be eligible for SCS therapy and will have already selected therapy with the Advanced Bionics Precision system, independent of possible inclusion in this study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01659073 -
Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation
|
N/A | |
| Recruiting |
NCT05914311 -
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
|
N/A | |
| Recruiting |
NCT05422456 -
The Turkish Version of Functional Disability Inventory
|
||
| Enrolling by invitation |
NCT05422443 -
The Turkish Version of Pain Coping Questionnaire
|
||
| Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
| Completed |
NCT04385030 -
Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury
|
N/A | |
| Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
| Completed |
NCT05103319 -
Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
|
||
| Completed |
NCT03687762 -
Back on Track to Healthy Living Study
|
N/A | |
| Completed |
NCT04171336 -
Animal-assisted Therapy for Children and Adolescents With Chronic Pain
|
N/A | |
| Completed |
NCT03179475 -
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
|
Phase 4 | |
| Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
| Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
| Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
| Recruiting |
NCT06060028 -
The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain
|
N/A | |
| Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
| 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 |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
| Terminated |
NCT03538444 -
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
|
N/A | |
| Not yet recruiting |
NCT05812703 -
Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
|