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Diabetic NeuropathiesSCSNCT00802022

Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy

A study testing spinal cord stimulation in people with Diabetic Neuropathies, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetic Neuropathies
What is being tested?
spinal cord stimulation
Type of treatment
Medical device
How many people
15 participants
Where
1 siteNetherlands
Study dates
Jan 2009to Jul 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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,
Show all 20Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University Hospital

    Maastricht, Limburg, 6229 HX

Other trials in Netherlands

About this study

Official title: Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy (PDP Study) A Pilot Study

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.

Read more

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%).

Being tested
spinal cord stimulation
Keywords
diabetic neuropathies, electric stimulation therapy
Medical subject headings
Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • spinal cord stimulationDevice

    Also called Medtronic leads and neurostimulator (CE mark 0123)

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline, 2 weeks after trial stimulation, 3, 6 and 12 months

Secondary outcomes (1)

  1. 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.

    Measured: Baseline, 2 weeks after trial stimulation, 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00802022
Sponsor's protocol ID
MEC 08-2-118
Acronym
SCS
Status last verified
Jul 2010
First submitted
3 Dec 2008
Last updated
8 Jul 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 8973433

  • 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.

    PubMed 18413161

  • 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.

    PubMed 29109298

Questions about this trial

What is this clinical trial studying?

A study testing spinal cord stimulation in people with Diabetic Neuropathies, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00802022, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2010.

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