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Percutaneous nerve stimulation in severe neuropathic pain patients due to spinal cord injury: a feasibility study

Percutaneous nerve stimulation in severe neuropathic pain patients due to spinal cord injury: a feasibility study - Percutaneous nerve stimulation in neuropathic pain due to SCI

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34598
Enrollment
15
Registered
2010-12-23
Start date
2011-02-25
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

neuropathic pain pain

Interventions

Percutaneous neurostimulation, eventually with additional electrical current on the needles, will be given according to a semi standardized protocol.

Sponsors

Reade, voormalig revalidatiecentrum amsterdam RCA
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)