Is there a correlation between the pain relief and the A-delta- and C-fiber function after topical application of lidocaine (5%) in patients with peripheral neuropathic pain?

Conditions: Patients with proven diagnosis of painful peripheral neuropathic pain syndromes as diagnosed as:1.Peripheral nerve lesion or2.Postherpetic neuralgia.
MedDRA version: 14.0Level: PTClassification code 10036376Term: Post herpetic neuralgiaSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.0Level: PTClassification code 10034586Term: Peripheral nerve injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2011-002083-25-DE

Lead Sponsor: BG University Hospital Bergmannsheil GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

Inclusion Criteria

Included will be patients 18 years and older either genera with:
-Proven Diagnosis of painful peripheral neuropathy for at least 3 months as diagnosed as:
1.Peripheral nerve lesion (i.e. pain within or adjacent to the area of nerve trauma or corresponding innervation territory or dermatome)
or
2.Postherpetic neuralgia (Subjects with pain following herpes zoster with > 3 months after healing of herpes zoster skin rash).
- At least moderate pain intensity under the current treatment.
- Unchanged and stable pain medication within the last 4 weeks.
- The patients have to display some remaining sensory function at the baseline QST.
- Intact skin in the area of lidocaine medicated plaster application.
- Females with childbearing potential must be using adequate contraception.
- Women of childbearing potential must have a negative urine ß-human chorionic gonadotropin (ß-HCG) pregnancy test.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Excluded will be patients with:
- History of current alcohol or drug abuse.
- Any scheduled surgery of painful procedure during the course of the trial.
- Presence of a disease that affects the subject’s compliance.
- Use of any topical anaesthetics in the area of pain within the last 6 months.
- Use of capsaicin (low or high-dose) in the area of pain within the last 6 months.
- Use of TENS within the area of pain in the last 4 weeks.
- Subjects who had nerve ablation by block or neurosurgical intervention for pain treatment at the affected area.
- Evidence or another cause of pain within the area of pain or another severe pain condition that may interfere with the trial aims or procedures.
- Severe loss of sensory function
- Contraindications or hypersensitivity to local anaesthetics of amide type or to any of the exipients.
- Intake of class I antiarrhythmic drugs (e.g. tocainide, mexilitine).
- Use of systemically applied local anaesthetics within the last 4 weeks
- Active herpes zoster lesion, dermatitis or skin lesions of any origin within the area of pain.
- Clinically relevant cardiac insufficiency (NYHA Class III to IV)
- Clinical relevant severe impairment of the kidney or liver function

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Aim of this trial is the assessment of the pain relief in patients suffering from peripheral neuropathic pain after treatment by topical application of lidocaine (5%).<br><br>;Secondary Objective: - Other sensory profile alterations in patients after treatment.;Primary end point(s): - The amount of pain relief (NRS-3)<br>- Number of treatment responders (as defined as subjects with a decrease of average pain (NRS-3) by > 30% at Visit 3 and Visit 5).<br>- Decrease of A-delta- and C-fiber function after treatment using topical application of lidocaine (5%) or placebo.;Timepoint(s) of evaluation of this end point: NRS-3 at Visit 3 (day 21) and Visit 5 (day 42) compared to baseline NRS-3 at Visit 2 (day 7) and 4 (day 24)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Changes of other QST parameters (tactile detection thresholds, thermal or mechanical hyperalgesia, dynamic mechanical allodynia). <br>- To assess the symptom intensity and their possible changes after application of lidocaine (5%) the PainDETECT and NPSI (German version) questionnaire will be used at baseline and at each obligatory follow-up, the Patient Global Impression of Change scale (PGIC) will be used as a non-specific tool as well.<br>- During the treatment a patient’s diary including the current, average and maximum pain intensity will be documented as well the intensity of some other complaints (e.g. nausea, drowsiness, sleep disorder etc.). ;Timepoint(s) of evaluation of this end point: see E.5.2