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Diabetic NeuropathiesPDPNCT01162993

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

A study testing Spinal Cord Stimulation in people with Diabetic Neuropathies and Pain, run by Maastricht University Medical Center at 2 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Spinal Cord Stimulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesNetherlands
Study dates
Apr 2010to Jan 2018
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:
  • Amitriptylin or an other tricyclic antidepressant and/or
  • Pregabalin (Lyrica®) or Gabapentin (Neurontin®) 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. 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.

Who cannot join

  • 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)
Show all 19Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Maastricht University Medical Center

    Maastricht, Limburg

  • UMC St. Radboud

    Nijmegen, Gelderland

Other trials in Netherlands

About this study

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.

Read more

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.

Being tested
Spinal Cord Stimulation
Keywords
Electric stimulation therapy, Diabetic Neuropathies
Medical subject headings
Diabetic Neuropathies, Pain

What participants receive

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

  • Spinal Cord StimulationProcedure or surgery

    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% 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.

Study groups in NCT01162993
Study groupRoleWhat they receive
Spinal Cord StimulationExperimentalSpinal cord stimulation
Receives: Procedure: Spinal Cord Stimulation
Treatment as usualNo interventionTreatment as usual

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: 6 months

Secondary outcomes (1)

  1. 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

    Measured: 6 and 12 months and 5 year follow-up

Timeline

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

  1. First posted15 Jul 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionJan 2013
  4. Study completionJan 2018 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01162993
Sponsor's protocol ID
MEC 09-2-120
Acronym
PDP
Status last verified
Oct 2016
First submitted
7 Jul 2010
Last updated
5 Jul 2017
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

  • Kumar K, Toth C, Nath RK. Spinal cord stimulation for chronic pain in peripheral neuropathy. Surg Neurol. 1996 Oct;46(4):363-9. doi: 10.1016/s0090-3019(96)00191-7.

    PubMed 8876718

  • 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

  • Daousi C, Benbow SJ, MacFarlane IA. Electrical spinal cord stimulation in the long-term treatment of chronic painful diabetic neuropathy. Diabet Med. 2005 Apr;22(4):393-8. doi: 10.1111/j.1464-5491.2004.01410.x.

    PubMed 15787662

  • O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

    PubMed 34854473

  • 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

  • Slangen R, Faber CG, Schaper NC, Joosten EA, van Dongen RT, Kessels AG, van Kleef M, Dirksen CD. A Trial-Based Economic Evaluation Comparing Spinal Cord Stimulation With Best Medical Treatment in Painful Diabetic Peripheral Neuropathy. J Pain. 2017 Apr;18(4):405-414. doi: 10.1016/j.jpain.2016.11.014. Epub 2016 Dec 11.

    PubMed 27965045

  • van Beek M, Slangen R, Schaper NC, Faber CG, Joosten EA, Dirksen CD, van Dongen RT, Kessels AG, van Kleef M. Sustained Treatment Effect of Spinal Cord Stimulation in Painful Diabetic Peripheral Neuropathy: 24-Month Follow-up of a Prospective Two-Center Randomized Controlled Trial. Diabetes Care. 2015 Sep;38(9):e132-4. doi: 10.2337/dc15-0740. Epub 2015 Jun 26. No abstract available.

    PubMed 26116722

  • Slangen R, Schaper NC, Faber CG, Joosten EA, Dirksen CD, van Dongen RT, Kessels AG, van Kleef M. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial. Diabetes Care. 2014 Nov;37(11):3016-24. doi: 10.2337/dc14-0684. Epub 2014 Sep 11.

    PubMed 25216508

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Cord Stimulation in people with Diabetic Neuropathies and Pain, run by Maastricht University Medical Center at 2 sites 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 19 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: status not confirmed, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

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: 6 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 NCT01162993, which also lists 9 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 5 Jul 2017.

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