To demonstrate that SCS is capable of treating otherwise refractory neuropathic pain after chemotherapy / radiotherapy.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is the change in neuropathic pain as measured by VAS
score after 6 months of SCS.
Secondary outcome
Secondary objectives are 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 following health outcome
measures: McGill Pain Questionnaire, EuroQoL 5D, HADS, patient's satisfaction,
changes in pain medication, changes in EEG features.
Background summary
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. Limited literature is
available on the effects of spinal cord stimulation (SCS) in this type of
neuropathic pain, nevertheless a case report on two patients demonstrated good
results. A pilot study to assess the effect of SCS in post-cancer neuropathic
pain will be relevant. Depending on the outcome of this pilot study on
post-cancer neuropathic pain, an RCT will be implemented.
Study objective
To demonstrate that SCS is capable of treating otherwise refractory neuropathic
pain after chemotherapy / radiotherapy.
Study design
The study is an open, prospective, pilot study
Intervention
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.
Study burden and risks
The questionnaires and EEG measurement are not associated with any risk. Spinal
cord stimulation refers to electrical stimulation of the spinal cord and is
considered a treatment that is minimally invasive, reversible, and adaptable.
The targeted study population consists of patients who have exhausted
conventional/conservative methods of relieving chronic pain due to post-cancer
neuropathy.
Haaksbergerstraat 55
Enschede 7513 ER
NL
Haaksbergerstraat 55
Enschede 7513 ER
NL
Listed location countries
Age
Inclusion criteria
- Peripheral neuropathic pain in lower extremities that exists for more than 6
months and is due to chemotherapy / radiotherapy.
- Patient cannot be treated further otherwise according to patients* medical
specialist.
- The pain-sensation on a visual analogue scale is 5 or more.
Exclusion criteria
- Psychological problems that requires treatment.
- Insufficient cooperation by patient (motivation, insight or communication).
- Coagulation irregularities/ Anti-coagulants.
- Life expectancy less than 1 year.
- Local infection at the site of the incision
- Implanted pacemaker, ICD or other neuromodulation system
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL37975.044.11 |
| OMON | NL-OMON25222 |