Pain Clinical Trial
Official title:
Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy: a Multicenter Randomised Controlled Trial (PDP Study)
Rationale: Diabetic neuropathy is one of the most common complications of Diabetes Mellitus
(DM). Pain is a common symptom of diabetic neuropathy, affecting 11-34% of patients suffering
form DM. The burden of disease of painful diabetic polyneuropathy (PDP) is high for both the
patient and society, due to significant pain levels, frequent co-morbidity, polypharmacy and
significant health resource use. Spinal cord stimulation (SCS) has been used for over 30
years to treat neuropathic pain. Several small clinical studies have shown a beneficial
effect of SCS on pain in PDP.
Objective: The primary objective of this study is to investigate whether SCS leads to
clinically relevant (≥50%) pain relief in patients with moderate-to-severe PDP in the lower
limbs after 6 months of treatment.
Secondary objectives to investigate 1) the effect of SCS on health related quality of life in
PDP; 2) the effect of SCS on the quality of sleep in PDP; 3) the effect of SCS on mood in
PDP; 4) the effect of SCS on blood glucose control in PDP; 5) the effect of SCS on large and
small nerve fibre functions in PDP; 6) identifying predictive factors for success of SCS
treatment of PDP; after 6 months 7) the effect of SCS on small fibre loss and regeneration in
PDP; and 8) costs, cost-utility and cost-effectiveness after 12 months of treatment.
Study design: the study is a multi centre randomized controlled trial. Study population:
Patients suffering from moderate-to-severe PDP in the lower limbs due to diabetes mellitus
type 1 or type 2 as diagnosed by clinical symptoms (glove and stocking distribution).
Intervention: patients assigned to group 1 will receive spinal cord stimulation (SCS) and/or
best (drug) treatment as possible, patients assigned to group 2 will receive best (drug)
treatment as possible.
Main study parameters/endpoints: The main study parameter will be the mean pain intensity
and/or maximal pain intensity during daytime and/or during night time as measured on a
weighted NRS and/or a PGIC for pain and sleep measured on a 7-point Likert scale, after 6
months of treatment.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: SCS related risks include: lead migration (14%), lead breakage (7%), implanted
pulse generator migration (1%), loss of therapeutic effect, lost or unpleasant paresthesias
(12%), infection or wound breakdown (10%), Pain at IPG incision site (12%), IPG pocket fluid
collection (5%). Treatment-as-usual related risks are related to the medication used and do
not increase due to participation in this study.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
| Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
| Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
| Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
| Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
| Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
| Completed |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
| Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
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 | |
| Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
| Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
| Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
| Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
| Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
| Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
| Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
| Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
| Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
| Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|