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

Ruhr University of Bochum

Status: Completed

Conditions: Postherpetic Neuralgia; Peripheral Nerve Injury

Treatments: Procedure: quantitative sensory testing (QST)

Study type: Observational

Funder types: Other

Identifiers

NCT01596491

Capsaicin2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

patients with peripheral nerve injury

Description:

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

Treatment:

Procedure: quantitative sensory testing (QST)

patients with postherpetic neuralgia

Description:

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

Treatment:

Procedure: quantitative sensory testing (QST)