Neuropathic Pain Clinical Trial
Official title:
Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)
The objective of this study is to evaluate the efficacy of BurstDR dorsal column stimulation, compared with conventional medical management, in improving pain and back-related physical function in subjects suffering with chronic, refractory axial low back pain with a neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an option.
A prospective, multi-center, randomized, controlled clinical study with an optional crossover component. The study is designed to evaluate the efficacy of BurstDR SCS in the treatment of chronic axial low back pain with a neuropathic component, compared to conventional medical management (CMM). Subjects will be followed in-clinic at 1,3, 6, 9, 12, 18 and 24 months and via phone call or optional clinic visit at 15- and 21-months. The primary endpoint will be assessed at the 6-month follow-up visit. Upon completion of the 6-month follow-up visit, subjects who are dissatisfied with therapy and receiving inadequate improvement with their treatment assignment will be allowed to cross-over to the other treatment arm, if desired. The study will enroll up to 270 patients at up to 30 sites. Subjects will be randomized in a 3:2 fashion to yield approximately 200 evaluable subjects for the primary endpoint analysis. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04699734 -
Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Completed |
NCT05235191 -
Effectiveness and Safety of Methadone Versus Placebo for the Control of Neuropathic Pain in Different Etiologies
|
Phase 3 | |
Completed |
NCT05845177 -
Persistent Pain After Hip Replacement
|
||
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Not yet recruiting |
NCT05949554 -
Electroencephalographic (EEG) Profils for Patients on Intravenous Ketamine.
|
||
Withdrawn |
NCT05052645 -
Ear Acupuncture for Neuropathic Pain
|
N/A | |
Completed |
NCT02930551 -
Neuromas as the Cause of Pain
|
N/A | |
Completed |
NCT02866396 -
Impact of Pregabalin in Chronic Users vs. a Perioperative Limited Prescription on Oxycodone Requirement
|
||
Completed |
NCT02824588 -
Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain
|
N/A | |
Active, not recruiting |
NCT02560545 -
Cannabinoids Effects on the Pain Modulation System
|
N/A | |
Enrolling by invitation |
NCT02485795 -
Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
|
N/A | |
Not yet recruiting |
NCT02246517 -
The Effect of N2O on Chronic Neuropathic Pain Patients
|
Phase 0 | |
Completed |
NCT02099890 -
The Effect of Diet on Chronic Inflammation and Related Disorders Following Spinal Cord Injury
|
Phase 3 | |
Completed |
NCT01946555 -
Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
|
N/A | |
Completed |
NCT01884662 -
Virtual Walking for Neuropathic Pain in Spinal Cord Injury
|
N/A | |
Completed |
NCT01718821 -
Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients
|
N/A | |
Completed |
NCT01669967 -
The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
|
N/A | |
Completed |
NCT01201317 -
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
|
Phase 2 | |
Completed |
NCT01207596 -
Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain
|
Phase 4 |