To demonstrate that SCS is capable of treating otherwise refractory neuropathic pain after chemotherapy / radiotherapy.
ID
Bron
Verkorte titel
Aandoening
neuropathic post-cancer pain,
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change in neuropathic pain as measured by VAS score after 6 months of SCS.
Achtergrond van het onderzoek
Several 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.
Doel van het onderzoek
To demonstrate that SCS is capable of treating otherwise refractory neuropathic pain after chemotherapy / radiotherapy.
Onderzoeksopzet
Evaluation 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.
Onderzoeksproduct en/of interventie
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. After 1, 3 and 6 months of SCS the patients have follow up visits where pain scores and other health outcome measures are acquired.
Publiek
P.O. Box 50000
C.C. Vos, de
Enschede 7500 KA
The Netherlands
+31 (0)53 4873532
c.devos@ziekenhuis-mst.nl
Wetenschappelijk
P.O. Box 50000
C.C. Vos, de
Enschede 7500 KA
The Netherlands
+31 (0)53 4873532
c.devos@ziekenhuis-mst.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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 patients’ 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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3055 |
| NTR-old | NTR3203 |
| CCMO | NL37975.044.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON47554 |