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

Recruiting

Conditions: neuropathic pain
pain
10041543

Registration Number: NL-OMON34598

Lead Sponsor: Reade, voormalig revalidatiecentrum amsterdam RCA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The feasibility will be evaluated with structured evaluation forms assessing<br /><br>performance of the intervention according to the protocol, attendance of the<br /><br>patients, experiences of patients, adverse events, and completion of the<br /><br>questionnaires. Other aspects are the recruitment process, and the percentage<br /><br>of responders. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome parameters include International Spinal Cord Injury Basic<br /><br>Pain Data Set self report measures; pain intensity (0-10 on a numerical rating<br /><br>scale); Neuropathic Pain Symptom Inventory; Hospital Anxiety and Depression<br /><br>Scale; Short Form-36 walk-wheel (SF36-ww); and Patients' Global Impression of<br /><br>Change scale. </p><br>