Trial Outcomes & Findings for Does the Application of Cold Decreases the Pain Associated in the Pose of a Patch of Capsaicine at High Concentration on the Carrier Patients of Localized Neuropathic Pains ?

Results Overview

Burning pain will be estimated by the patient using a non-graduated 10 cm line, presented horizontally to the patient with the extreme position of the vertical border on the left (0mm) representing the absence of perceived pain and the extreme position on the right (10 cm), the perception of the maximum pain that the patient can imagine. The information obtained is measured and translated into a score between 0 and 10. The patient will be asked: "How would you rate the intensity of pain caused by Qutenza patch application?

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

after 1 hour of installation of Qutenza patch

Results posted on

2025-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Qutenza® without refrigerated cushion Qutenza® without refrigerated cushion	Qutenza® with refrigerated cushion Qutenza® with refrigerated cushion refrigerated cushion: refrigerated cushion
Overall Study STARTED	50	50
Overall Study COMPLETED	44	45
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Qutenza® without refrigerated cushion Qutenza® without refrigerated cushion	Qutenza® with refrigerated cushion Qutenza® with refrigerated cushion refrigerated cushion: refrigerated cushion
Overall Study Protocol Violation	1	0
Overall Study Lost to Follow-up	5	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Qutenza® Without Refrigerated Cushion n=49 Participants Qutenza® without refrigerated cushion	Qutenza® With Refrigerated Cushion n=50 Participants Qutenza® with refrigerated cushion refrigerated cushion: refrigerated cushion	Total n=99 Participants Total of all reporting groups
Age, Continuous	51 years STANDARD_DEVIATION 12 • n=49 Participants	49 years STANDARD_DEVIATION 14 • n=50 Participants	50 years STANDARD_DEVIATION 13 • n=99 Participants
Sex: Female, Male Female	34 Participants n=49 Participants	40 Participants n=50 Participants	74 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=49 Participants	10 Participants n=50 Participants	25 Participants n=99 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: after 1 hour of installation of Qutenza patch

Population: Intent to treat Population (all participants who received a Qutenza patch)

Burning pain will be estimated by the patient using a non-graduated 10 cm line, presented horizontally to the patient with the extreme position of the vertical border on the left (0mm) representing the absence of perceived pain and the extreme position on the right (10 cm), the perception of the maximum pain that the patient can imagine. The information obtained is measured and translated into a score between 0 and 10. The patient will be asked: "How would you rate the intensity of pain caused by Qutenza patch application?

Outcome measures

Outcome measures
Measure	Qutenza® without refrigerated cushion n=49 Participants Qutenza® without refrigerated cushion	Qutenza® with refrigerated cushion n=50 Participants Qutenza® with refrigerated cushion refrigerated cushion: refrigerated cushion
Visual Analogue Pain Scale (Burning Pain)	6.99 units on a scale Interval 6.2 to 7.77	3.78 units on a scale Interval 3.0 to 4.56

Adverse Events

Qutenza® without refrigerated cushion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Qutenza® with refrigerated cushion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Yves-Marie PLUCHON

Centre Hospitalier Départemental Vendée

Phone: 251446248

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place