Treatment with small Qutenza patches over painful trigger points in scars after operation: A blinded study using placebo paths versus active Qutenza patch

Phase 1

• Conditions: Post-operative neuropathic pain; MedDRA version: 21.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852; MedDRA version: 20.0Level: LLTClassification code 10077974Term: Peripheral neuropathic painSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-001022-57-DK
• Lead Sponsor: Wojciech Zbigniew Pawlak

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-17
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

•Age > 18 years old
•Patients with chronic pain for =3 months, with a daily VAS pain scores =40 mm (VAS 0-100mm, 0=no pain and 100=worst possible pain) after sur-gery
•Patients have a score =7 in the neuropathic pain questionnaire DN4
•Negative pregnancy test in fertile women.
•Patients with at least one identifiable trigger point in relation to incision in a mobile body part or a positive outcome from our first study (7). A trigger point is defined as an area in relation to the incision from surgery, in which a light pressure from a cotton pin radiate pain to the nearby area and exudes a motor reflex causing withdrawal of the body part related to the incision. Trigger points will be identified using ultrasound scanning.
•Skin must be intact and dry without wounds or stripes in an area of 6 cm in diameter from the trigger point
•A written and signed informed consent to participate in the study after having fully understood the contents of the protocol and restrictions

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

•Patients who cannot cooperate
•Patients who can cooperate but do not understand or speak Danish
•Patients with allergy to the drugs used in the study, ingredients or compo-nents in the matrix and cleansing creme*
•Women who are not using acceptable effective contraception
•Patients suffering from other neuropathic pain conditions.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified