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NCT Number: NCT01596491

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

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.

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Key information

Conditions

Peripheral Nerve Injury Nervous System Diseases Neuralgia Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nerve Injuries Peripheral Nervous System Diseases Postherpetic Neuralgia Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bergmannsheil, Department for pain management

Bochum, Germany

About this study

The topical application of a high dosage of capsaicin (8%) is a new promising approach. There is only little knowledge about the extent and the duration of drug-induced changes of detection and pain thresholds based on a currently recommended standardized quantitative sensory testing (QST). The assessment of QST changes would be an important step forward to understand the way of action as well as the time course of the presumed recovering of the C-fiber function after topical application of a high concentration capsaicin patch.

10 patients suffering from peripheral neuropathic pain due to peripheral nerve injury and 10 patients suffering from postherpetic neuralgia will be investigated by QST following the protocol of DFNS (German Research Network on Neuropathic Pain), using both thermal and mechanical nociceptive as well as non-nociceptive stimuli.

QST will be performed at the following times:

  • at baseline
  • 2, 4, 6, 8 weeks later, and every two weeks at least until re-occurrence of pain and/or recovering of the capsaicin-induced worsening of the C-fiber function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. 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

    Time frame: 8 weeks after capsaicin-patch (8%) application

    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)

  2. 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

    Time frame: 8 weeks after capsaicin-patch (8%) application

    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)

Secondary outcomes

  1. Decrease of thermal Hyperalgesia

    Time frame: 8 weeks after capsaicin-patch (8%) application

    change of thermal hyperalgesia measured by QST (z-value of heat pain and cold pain threshold)from baseline to 8 weeks after capsaicin-application

  2. Decrease of mechanical hyperalgesia

    Time frame: 8 weeks after capsaicin-patch (8%) application

    change of mechanical hyperalgesia measured by QST (z-value of mechanical pain threshold and mechanical pain sensitivity) from baseline to 8 weeks after capsaicin-application

  3. Decrease of dynamical mechanical allodynia

    Time frame: 8 weeks after capsaicin-patch (8%) application

    change of dynamical mechanical allodynia measured by QST from baseline to 8 weeks after capsaicin-application

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

    Time frame: 8 weeks after application of capsaicin-patch (8%)

    comparison of z-values for cold, warmth and mechanical detection threshold to the outcome of the german versions of the following questionnaires: PainDETECT, NPSI (Neuropathic Pain Symptom Inventory) and Patient's global impression of change (PGIC), analyzed by ANCOVA

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

Kind and Duration of Possible Changes of the Sensory Profiles After the Topical Application of Capsaicin (8%) in Patients With Peripheral Neuropathic Pain

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 11, 2012
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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