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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25222
Enrollment
11
Registered
2011-12-08
Start date
2012-01-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuropathic post-cancer pain,

Interventions

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 S

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Change in neuropathic pain as measured by VAS score after 6 months of SCS.

Secondary

MeasureTime frame
An 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.

Contacts

Public ContactC.C. Vos, de

Medisch Spectrum Twente, Department of Neurosurgery, P.O. Box 50000

c.devos@ziekenhuis-mst.nl+31 (0)53 4873532

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)