A Pilot Study into the Effect of Topical Menthol for Patients with Neuropathic-Type Pain. - Topical menthol in neuropathic-type pain.

Conditions: The condition under investigation is neuropathic-type pain. This may be due to a variety of causes including malignant neuropathic-type pain (such as tumour-related nerve compression or cancer-related bone pain) or chemotherapy induced neuropathy.
MedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic pain

Registration Number: EUCTR2008-001684-11-GB

Lead Sponsor: niversity of Edinburgh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Patients with neuropathic-type pain.
2.Male or female aged 18 years or over at study entry.
3.Patients whose usual medical team agree to their taking part in the study.
4.Patients who provide written consent to participation in the study after explanation of the study protocol.
5.Patients who consent to the relevant parts of their medical notes being accessed by the Research Team.
6.Patients who, in the opinion of the investigator, are willing and able to attend as an outpatient and are able to complete the various assessments.
7.Patients need to have the ability to complete questionnaire assessments in English language.
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

1.Patients with any contraindication to the use of topical therapy or menthol.
2.Patients who are confused or suffering from significant psychiatric illness, which would hinder their completion of the study.
3.Patients whose condition is unstable or rapidly deteriorating, such that they are unlikely to be able to contribute to the study.
4.Patients with any other medical condition that would confound the objectives of the study.
5.Patients who would be adversely affected by study participation. This would include those who find completion of the study too burdensome.
6.Patients who, in the opinion of the Research Team or their usual medical team, would be unable to complete the study protocol for any other reason.
7.Patients who are unable or refuse to provide written consent to inclusion in the study after explanation of the study protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary outcome measure is whether 1% topical menthol provides clinically significant pain relief in patients with pain with a neuropathic element. The hypothesis being tested is whether TRPM8 channels have an important analgesic role in clinical neuropathic pain states.;Secondary Objective: The secondary outcome measures are the effects of topical menthol on other components of pain perception such as mood, function and general sensation. We aim to establish whether particular aspects of pain will respond better to this form of treatment.;Primary end point(s): The primary outcome will be assessed at the 4 – 6 week visit. A clinical response will be defined as a reduction of two or more points of worst pain on the 0-10 Visual Analogue Scale between baseline and this point.

Secondary Outcome Measures