Study of Possible Changes in QST After Application of Capsaicin on Patients With Peripheral Neuropathic Pain

NCT01596491 | Completed

• 1 other identifier: Capsaicin2011
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of neuropathic pain ist still a challenge. A new promising therapy is the use of capsaicin on skin. The investigators first experiences with capsaicin in patients with peripheral nerve injury showed changes in the sensibility, which achieved its maximal extent after four weeks and was regressive, but not completely abolished 1,5 months after application. In this study the investigators hope to specify, how long and in which way exactly this changes in sensibility appear.

Conditions

Peripheral Nerve Injury; Postherpetic Neuralgia

Keywords

peripheral nerve injury; postherpetic neuralgia; PNI; PHN; Capsaicin; QST; quantitative sensory testing; sensory profile; neuropathic pain

Outcome Measures

Primary Outcomes (2)

• Duration of the functional loss of the C- and A-delta-fibres after therapeutic application of capsaicin 8% as measured by the impairment of the thermal thresholds

  measurement of thermal detection thresholds for warmth (WDT) and cold (CDT) by QST (standard DFNS protocol), change of z-values for WDT and CDT from baseline to 8 weeks after capsaicin-application (ANOVA)

  8 weeks after capsaicin-patch (8%) application

• Extent of the functional loss of the C- and A-delta-fibres after therapeutic application of capsaicin 8% as measured by the impairment of the thermal thresholds

  measurement of thermal detection thresholds for warmth (WDT) and cold (CDT) by QST (standard DFNS protocol), change of z-values for WDT and CDT from baseline to 8 weeks after capsaicin-application (ANOVA)

  8 weeks after capsaicin-patch (8%) application

Secondary Outcomes (4)

• Decrease of thermal Hyperalgesia

  8 weeks after capsaicin-patch (8%) application

• Decrease of mechanical hyperalgesia

  8 weeks after capsaicin-patch (8%) application

• Decrease of dynamical mechanical allodynia

  8 weeks after capsaicin-patch (8%) application

• Correlation of efficacy on the sensory function and the reported soothing of symptoms after capsaicin-application

  8 weeks after application of capsaicin-patch (8%)

Study Arms (2)

patients with peripheral nerve injury

10 patients with neuropathic pain, because of peripheral nerve injury will obtain a baseline-QST and after capsaicin-application a QST 2, 4, 6, 8 and every 2 weeks until re-occurrence of pain and/or recovery of the capsaicin-induced sensory deficits

Procedure: quantitative sensory testing (QST)

patients with postherpetic neuralgia

10 patients with neuropathic pain, because of postherpetic neuralgia will obtain a baseline-QST and after capsaicin-application a QST 2, 4, 6, 8 and every 2 weeks until re-occurrence of pain and/or recovery of the capsaicin-induced sensory deficits

Procedure: quantitative sensory testing (QST)

Interventions

quantitative sensory testing (QST) PROCEDURE

with QST the small-fibre function is tested by registering thermal and mechanical thresholds, so that changes in the sensory profile can by specified

patients with peripheral nerve injury; patients with postherpetic neuralgia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

proved peripheral neuropathy (e.g. peripheral nerve lesion, postherpetic neuralgia)

You may qualify if:

• age \>18 years with signed informed consent
• with planned topical application of capsaicin (8%) and with no involvement in any other study
• with neurological proved peripheral neuropathy (e.g. peripheral nerve lesion, postherpetic neuralgia) and with remaining moderate pain intensity under the current treatment (\> NRS 3; numeric rating scale 0-10)
• some remaining sensory function at the baseline QST with z-scores ≥ - 3 for cold, warmth and tactile thresholds

You may not qualify if:

• with missing informed consent
• with any contraindications for capsaicin application
• with diabetes mellitus,
• using lidocaine patch in the test area in the last 6 months before enrollment
• with inadequate knowledge of the german language

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Bergmannsheil, Department for pain management

Bochum, Germany

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries; Neuralgia, Postherpetic; Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoph Maier, Prof.Dr.med

  University hospital Bergmannsheil department of pain management

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Dep. of Pain Management

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: May 11, 2012
• Study Start: April 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

DE (1)