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

July 3, 2017 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
        • UMC St. Radboud
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:
    • Amitriptylin or an other tricyclic antidepressant and/or
    • Pregabalin (Lyrica®) or Gabapentin (Neurontin®) 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. Starting dosage was based on individual patient characteristics. Each drug was tried for at least 3 weeks and dose was raised once, if possible. 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 increase dosage during the study.
  • Mean pain intensity during daytime and/or night time should be 5 or higher measured on a numeric rating scale (NRS). Pain during daytime will be scored 3 times per day during for 4 days according to Jensen.
  • Patient's age is between 18 and 75 years.

Exclusion Criteria:

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

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

    • Drugs: cocaine, heroine, marihuana.
    • Alcohol: wine, beer, liquor (max 5E / day)
    • Medication: benzodiazepines.
  • Insufficient cooperation from the patient (little motivation, understanding or communication)
  • Blood clotting disorder, when using 2 or more different kinds of anti coagulation
  • Immune deficiency (HIV-positive, corticosteroids with a dose equivalent to > prednisolone 10 mg, immunodepressive, etc.)
  • Peripheral vascular disease without palpable peripheral pulses at both feet (inclusion is possible if pulses are absent, but ankle brachial index is between 0.7 and 1.2 in both feet)
  • Active foot ulceration
  • Life expectancy < 1 year
  • Pacemaker
  • Local infection or other skin disorders at site of incision
  • Psychiatric problems potentially interfering with cooperation in the study
  • Pregnancy
  • Severe cardiac or pulmonary failure (> NYHA classification II)
  • Unstable blood glucose control (change in HbA1c>1,0% in three months prior to inclusion)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as usual
Experimental: Spinal Cord Stimulation
Spinal cord stimulation
Procedure: Spinal Cord Stimulation
The intervention is spinal cord stimulation and will be used for 2 weeks trial stimulation. After clinical successful pain relief (≥50% relief of pain intensity on a weighted numeric rating scale (NRS) or a score of ≥6 on a seven-point Likert scale (1=very much worse; 7=very much improved) of the PGIC scale for pain and sleep) a definite spinal cord system will be implanted.
Other Names:
  • Medtronic leads and neurostimulator (CE mark 0123)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect SCS on health related quality of life, quality of sleep, mood, blood glucose control, large/small nerve fibre functions, predictive factors success of SCS treatment, small fibre loss/regeneration, cost-utility and cost-effectiveness
Time Frame: 6 and 12 months and 5 year follow-up
6 and 12 months and 5 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Maarten van Kleef, Prf. Dr., Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

July 7, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (Estimate)

July 15, 2010

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 09-2-120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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