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Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy (SCS)

Primary Purpose

Diabetic Neuropathies

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
spinal cord stimulation
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring diabetic neuropathies, electric stimulation therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate-to-severe PDP in the lower limbs

    • The pain intended to treat has been present for more than 12 months
    • Previous treatment has been unsuccessful (insufficient pain relief and/or unacceptable side-effects) with drugs from the following drug categories:
    • Amitriptyline or an other tricyclic antidepressant and/or
    • Pregabalin (Lyrica), Gabapentin (Neurontin) or Carbamazepine and/or
    • Duloxetine (Cymbalta) and/or
    • Tramadol or strong opioids Patients were treated with 3 drugs from the above mentioned drug categories and followed the treatment algorithm for painful diabetic polyneuropathy according to Jensen. Each drug is tried for 3 weeks and dose is raised once. By insufficient pain relief and/or unacceptable side-effects, the drug treatment was stopped. Patients reached a steady state in medication use and it is not allowed to change the use of medication during the study.
  • Mean pain intensity should be 5 or higher measured on a numeric rating scale (NRS), which will be scored 3 times per day during 4 days according to Jensen.
  • Patients age is between 18 and 75 years.

Exclusion Criteria:

  • The patient has had neuromodulation therapy during the month before the intake
  • The patient has ever had neuromodulation
  • Neuropathic pain prevalent in the upper limbs (NRS above 3)
  • Neuropathy or chronic pain of other origin than diabetes mellitus (NRS above 3)

  • Addiction: drugs, alcohol (5E/day) and/or medication

    • Drugs: cocaine, heroine, marihuana,
    • Alcohol: wine, beer, liquor.
    • Medication: benzodiazepines, morphine receptor agonists.
  • Insufficient cooperation from the patient (little motivation, understanding or communication)
  • Blood clotting disorder
  • Immune deficiency (HIV-positive, corticosteroids with a dose equivalent to prednisolone 10 mg, immunosuppressive, etc.)
  • Peripheral vascular disease, no palpable peripheral pulsations at the feet (inclusion is possible if pulsations are absent, but ankle/brachial index is between 0.7 and 1.2 in both feet)
  • Active foot ulceration
  • Life expectancy shorter than 1 year
  • Pacemaker
  • Local infection or other skin disorders at site of incision
  • Psychiatric disorders
  • Pregnancy
  • Severe cardiac or pulmonary failure (NYHA classification II or higher)
  • Unstable blood glucose control (change in HbA1c more than 1,0% (absolute value) in three months prior to inclusion)

Sites / Locations

  • Maastricht University Hospital

Outcomes

Primary Outcome Measures

Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale.

Secondary Outcome Measures

The practical- and technical feasibility of the procedures, predicting successful pain relief by SCS by classifying patients according to the MDNS. Define possible other predictors for successful pain relief.

Full Information

First Posted
December 3, 2008
Last Updated
July 7, 2010
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00802022
Brief Title
Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy
Acronym
SCS
Official Title
Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy (PDP Study) A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rationale: Diabetic neuropathy is one of the most common complications of Diabetes Mellitis (DM). Pain is a common symptom of diabetic neuropathy, affecting 11-34% of patients suffering form DM. The current available medication often provides insufficient pain relief and/or has unacceptable side effects. Spinal cord stimulation (SCS) has been used for over 30 years to treat neuropathic pain. Various small clinical studies have shown a beneficial effect of SCS on pain in PDP. Objective: This study is a preparation to a RCT to investigate whether SCS is a good indication in patients which suffer from pain with moderate-to-severe PDP in the lower limbs. The main objective of this study is whether SCS leads to sufficient pain relief and to obtain insight into the working mechanism of SCS. The hypothesis is that the effect SCS is most effective in patients without major sensory deficits. Furthermore, practical feasibility of the test procedures described in the study protocol will be examined, including the questionnaires to be filled out by the patient. Also, technical feasibility of SCS will be investigated. Besides the feasibility, the possibility of predicting successful pain relief by SCS by classifying patients according to the Michigan Diabetic Neuropathy Score will be assessed. Furthermore, possible other predictors for successful pain relief by SCS will be defined. Study design: the study is a pilot study in preparation to a RCT to investigate the effect of spinal cord stimulation on pain in moderate-to-severe PDP patients. Study population: patients suffering from moderate-to-severe PDP in the lower limbs as diagnosed by clinical symptoms and supported by the Michigan Diabetic Neuropathy Score. Intervention: patients will receive 2 weeks of trial stimulation and best (drug) treatment as usual. Main study parameters/endpoints: Main study parameter is the pain score as measured by a numeric rating scale (NRS) according to Jensen and a Patient Global Impression of Change for pain measured on a 7-point Likert scale. 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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
diabetic neuropathies, electric stimulation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
spinal cord stimulation
Other Intervention Name(s)
Medtronic leads and neurostimulator (CE mark 0123)
Intervention Description
The intervention is spinal cord stimulation and will be used for 2 weeks trial stimulation. After clinical successful pain relief (50% of more pain reduction)a definite spinal cord system will be implanted.
Primary Outcome Measure Information:
Title
Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale.
Time Frame
Baseline, 2 weeks after trial stimulation, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
The practical- and technical feasibility of the procedures, predicting successful pain relief by SCS by classifying patients according to the MDNS. Define possible other predictors for successful pain relief.
Time Frame
Baseline, 2 weeks after trial stimulation, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate-to-severe PDP in the lower limbs The pain intended to treat has been present for more than 12 months Previous treatment has been unsuccessful (insufficient pain relief and/or unacceptable side-effects) with drugs from the following drug categories: Amitriptyline or an other tricyclic antidepressant and/or Pregabalin (Lyrica), Gabapentin (Neurontin) or Carbamazepine and/or Duloxetine (Cymbalta) and/or Tramadol or strong opioids Patients were treated with 3 drugs from the above mentioned drug categories and followed the treatment algorithm for painful diabetic polyneuropathy according to Jensen. Each drug is tried for 3 weeks and dose is raised once. By insufficient pain relief and/or unacceptable side-effects, the drug treatment was stopped. Patients reached a steady state in medication use and it is not allowed to change the use of medication during the study. Mean pain intensity should be 5 or higher measured on a numeric rating scale (NRS), which will be scored 3 times per day during 4 days according to Jensen. Patients age is between 18 and 75 years. Exclusion Criteria: The patient has had neuromodulation therapy during the month before the intake The patient has ever had neuromodulation Neuropathic pain prevalent in the upper limbs (NRS above 3) Neuropathy or chronic pain of other origin than diabetes mellitus (NRS above 3) Addiction: drugs, alcohol (5E/day) and/or medication Drugs: cocaine, heroine, marihuana, Alcohol: wine, beer, liquor. Medication: benzodiazepines, morphine receptor agonists. Insufficient cooperation from the patient (little motivation, understanding or communication) Blood clotting disorder Immune deficiency (HIV-positive, corticosteroids with a dose equivalent to prednisolone 10 mg, immunosuppressive, etc.) Peripheral vascular disease, no palpable peripheral pulsations at the feet (inclusion is possible if pulsations are absent, but ankle/brachial index is between 0.7 and 1.2 in both feet) Active foot ulceration Life expectancy shorter than 1 year Pacemaker Local infection or other skin disorders at site of incision Psychiatric disorders Pregnancy Severe cardiac or pulmonary failure (NYHA classification II or higher) Unstable blood glucose control (change in HbA1c more than 1,0% (absolute value) in three months prior to inclusion)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten van Kleef, prof. dr.
Organizational Affiliation
Maastricht University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Hospital
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
8973433
Citation
Tesfaye S, Watt J, Benbow SJ, Pang KA, Miles J, MacFarlane IA. Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy. Lancet. 1996 Dec 21-28;348(9043):1698-701. doi: 10.1016/S0140-6736(96)02467-1.
Results Reference
background
PubMed Identifier
18413161
Citation
de Vos CC, Rajan V, Steenbergen W, van der Aa HE, Buschman HP. Effect and safety of spinal cord stimulation for treatment of chronic pain caused by diabetic neuropathy. J Diabetes Complications. 2009 Jan-Feb;23(1):40-5. doi: 10.1016/j.jdiacomp.2007.08.002. Epub 2008 Apr 16.
Results Reference
background
PubMed Identifier
29109298
Citation
van Beek M, Geurts JW, Slangen R, Schaper NC, Faber CG, Joosten EA, Dirksen CD, van Dongen RT, van Kuijk SMJ, van Kleef M. Severity of Neuropathy Is Associated With Long-term Spinal Cord Stimulation Outcome in Painful Diabetic Peripheral Neuropathy: Five-Year Follow-up of a Prospective Two-Center Clinical Trial. Diabetes Care. 2018 Jan;41(1):32-38. doi: 10.2337/dc17-0983. Epub 2017 Nov 6.
Results Reference
derived

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Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy

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