To evaluate the feasibility of PENS in patients with chronic neuropathic pain due to SCI.
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The feasibility will be evaluated with structured evaluation forms assessing
performance of the intervention according to the protocol, attendance of the
patients, experiences of patients, adverse events, and completion of the
questionnaires. Other aspects are the recruitment process, and the percentage
of responders.
Secondary outcome
The secondary outcome parameters include International Spinal Cord Injury Basic
Pain Data Set self report measures; pain intensity (0-10 on a numerical rating
scale); Neuropathic Pain Symptom Inventory; Hospital Anxiety and Depression
Scale; Short Form-36 walk-wheel (SF36-ww); and Patients' Global Impression of
Change scale.
Background summary
One of the most severe and common complications of a spinal cord injury (SCI)
is neuropathic pain. Medication is usually not sufficient to treat effectively
neuropathic pain, and it can cause side effects. Acupuncture has been suggested
as a treatment modality for neuropathic pain. Only a few studies have been done
to evaluate the effectiveness of acupuncture in patients with chronic pain due
to SCI . The methodological quality of current studies is poor. We are planning
a high quality randomized clinical trial on the effectiveness of percutaneous
electrical neurostimulation (PENS), derived from acupuncture, in patients with
chronic pain due to SCI. We will first conduct a feasibility study.
Study objective
To evaluate the feasibility of PENS in patients with chronic neuropathic pain
due to SCI.
Study design
A feasibility study with one group pre-test/post-test design. Patients will be
given 12 sessions of PENS within 18 weeks. Feasibility will be evaluated after
8 weeks (T8),18 weeks (T18) and 12 weeks after the last treatment (T30).
Outcome parameters will be measured at T0, T8, T18 and T30. In total 15
patients will be included.
Intervention
Percutaneous neurostimulation, eventually with additional electrical current on
the needles, will be given according to a semi standardized protocol.
Study burden and risks
Because of the intractable pain a substantial part of the spinal cord injury
patients experience, the benefit of PENS could be considerable. PENS is very
safe in the hands of experienced and qualified practitioners. The only
side-effects that could occur are minor like slight haemorrhage, haematoma and
dizziness
Postbus 58271
1040 HG Amsterdam
NL
Postbus 58271
1040 HG Amsterdam
NL
Listed location countries
Age
Inclusion criteria
• 18 to 70 years of age,
• SCI at any level and any American Spinal Cord Association (ASIA) impairment Score
• SCI occurred at least 6 months before inclusion
• Diagnosis neuropathic pain on the DN4 diagnostic scale (>= 4)
• At least 6 months of neuropathic pain should be present with a rating of 4 or more on a numeric rating scale from 0 to 10
Exclusion criteria
• Pregnancy or planned pregnancy in the study-period
• Evidence of significant cardiac conduction disturbance
• Current or recent substance abuse problem
• Evidence that would prevent giving informed consent or hinder one*s ability to follow through with the study based on the attending physicians clinical judgment (e.g. a serious psychological disorder, language difficulties)
• No informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33024.048.10 |