search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Spinal cord stimulation for treating neuropathic pain after chemotherapy / radiotherapy; a pilot study.


- candidate number10654
- NTR NumberNTR3203
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-dec-2011
- Secondary IDsNL37975 CCMO
- Public TitleSpinal cord stimulation for treating neuropathic pain after chemotherapy / radiotherapy; a pilot study.
- Scientific TitleSpinal cord stimulation for treating neuropathic pain after chemotherapy / radiotherapy; a pilot study.
- ACRONYMSCS002p
- hypothesisTo demonstrate that SCS is capable of treating otherwise refractory neuropathic pain after chemotherapy / radiotherapy.
- Healt Condition(s) or Problem(s) studiedNeuropathic post-cancer pain
- Inclusion criteria1. Peripheral neuropathic pain in lower extremities that exists for more than 6 months and is due to chemotherapy or radiotherapy;
2. Patient cannot be treated further otherwise according to patientsí medical specialist;
3. Physiotherapy and/or manual therapy, lumbar sympathetic ganglion and/or RIS-blocks and/or oral medication give insufficient pain relief or unacceptable side-effects;
4. The pain-sensation on a visual analogue scale is 5 or more (recording both for day and night time).
- Exclusion criteria1. Age < 18 years;
2. Psychological problems that requires treatment;
3. Addiction (i.e. compulsory) to: drugs, alcohol, medication;
4. Insufficient cooperation by patient (motivation, insight or communication);
5. Coagulation irregularities/ Anti-coagulants;
6. Immune compromised;
7. Life expectancy less than 1 year;
8. Pregnancy;
9. Local infection at the site of the incision;
10. Implanted pacemaker, ICD or other neuromodulation system.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2012
- planned closingdate1-dec-2013
- Target number of participants11
- InterventionsAll patients will have a trial stimulation period with an external SCS pulse generator. If the trial is successful ( > 50% pain reduction) an SCS system will be implanted. After 1, 3 and 6 months of SCS the patients have follow up visits where pain scores and other health outcome measures are acquired.
- Primary outcomeChange in neuropathic pain as measured by VAS score after 6 months of SCS.
- Secondary outcomeAn evaluation of the efficacy of SCS Treatment in patients with post cancer neuropathic pain as measured by change in pain intensity at all visits, and an evaluation of other health outcome measures.
- TimepointsEvaluation visits (to acquire pain scores and other health outcome measures) will occur at 1, 3 and 6 months after implantation.
After completion of the 6 months study treatment period, all patients will be followed in accordance with standard medical care.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESIr. C.C. Vos, de
- CONTACT for SCIENTIFIC QUERIESIr. C.C. Vos, de
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente
- PublicationsN/A
- Brief summarySeveral publications have shown that post-cancer neuropathic pain is a common and disabling side effect of chemotherapy and radiotherapy and yet medical treatment of this pain remains largely ineffective. A pilot study to assess the effect of SCS in post-cancer neuropathic pain will be relevant. This study is an open, prospective, pilot study. 11 patients with refractory neuropathic pain caused by chemotherapy / radiotherapy will be included. They should be eligible for spinal cord stimulation and have VAS scores for pain > 5. All patients will have a trial stimulation period with an external SCS pulse generator. If the trial is successful ( > 50% pain reduction) an SCS system will be implanted. Evaluation visits (to acquire pain scores and other health outcome measures) will occur at 1, 3 and 6 months after implantation. Primary outcome measure is the change in neuropathic pain as measured by VAS score after 6 months of SCS. After completion of the 6 months study treatment period, all patients will be followed in accordance with standard medical care.
- Main changes (audit trail)
- RECORD8-dec-2011 - 29-dec-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl