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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01596491
First received: February 23, 2012
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Peripheral Nerve Injury
Postherpetic Neuralgia
Procedure: quantitative sensory testing (QST)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Kind and Duration of Possible Changes of the Sensory Profiles After the Topical Application of Capsaicin (8%) in Patients With Peripheral Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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)

  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Decrease of thermal Hyperalgesia [ Time Frame: 8 weeks after capsaicin-patch (8%) application ] [ Designated as safety issue: No ]
    change of thermal hyperalgesia measured by QST (z-value of heat pain and cold pain threshold)from baseline to 8 weeks after capsaicin-application

  • Decrease of mechanical hyperalgesia [ Time Frame: 8 weeks after capsaicin-patch (8%) application ] [ Designated as safety issue: No ]
    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

  • Decrease of dynamical mechanical allodynia [ Time Frame: 8 weeks after capsaicin-patch (8%) application ] [ Designated as safety issue: No ]
    change of dynamical mechanical allodynia measured by QST from baseline to 8 weeks after capsaicin-application

  • 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%) ] [ Designated as safety issue: No ]
    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


Enrollment: 20
Study Start Date: April 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
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 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)
with QST the small-fibre function is tested by registering thermal and mechanical thresholds, so that changes in the sensory profile can by specified

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596491

Locations
Germany
Bergmannsheil, Department for pain management
Bochum, Germany
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Study Director: Christoph Maier, Prof.Dr.med University hospital Bergmannsheil department of pain management
  More Information

No publications provided

Responsible Party: Christoph Maier, Prof. Dr., Head of the Dep. of Pain Management, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01596491     History of Changes
Other Study ID Numbers: Capsaicin2011
Study First Received: February 23, 2012
Last Updated: December 19, 2012
Health Authority: Germany: Ethics committee of the Faculty of Medicine, Ruhr University Bochum

Keywords provided by Ruhr University of Bochum:
peripheral nerve injury
postherpetic neuralgia
PNI
PHN
Capsaicin
QST
quantitative sensory testing
sensory profile
neuropathic pain

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Peripheral Nerve Injuries
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trauma, Nervous System
Capsaicin
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014