Localized Neuropathic Pain
Conditions
Brief summary
Nursing study, prospective, randomized, two-center open-label. Patients will be randomized into two groups during their first laying Qutenza®: * Patients receiving the laying of Qutenza® without refrigerated cushion * Patients receiving the laying of Qutenza® associated with a refrigerated cushion The objective of the study is to evaluate the effectiveness of the application of cold to the reduction of pain (burning) after one hour of patch installation high concentration capsaicin (Qutenza®) in patients localized neuropathic pain.
Interventions
OTHERrefrigerated cushion
refrigerated cushion
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Major * Do not opposing the participation in the study * Monitoring in the case of localized neuropathic pain * Diagnostic with neuropathic pain score ≥ 4 * Neuropathic pain conventional treatment failure of first-line * Front advantage of laying a first patch Qutenza® * With ability to understand the proposed study
Exclusion criteria
* Patch Installation on the feet, face, mucous membranes * Eutectic mixture of local anesthetics (EMLA) Pose premedication * Having Already received prior to the installation of a patch of Qutenza® * Allergy to components Qutenza® * Known and poorly stabilized hypertension * Known cryoglobulinaemia * Pregnant or lactating women * Patient enjoying a measure of legal protection (guardianship, guardianship ...) * Private Patient freedom * No affiliation to a social security scheme. * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Pain Scale (Burning Pain) | after 1 hour of installation of 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? |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Qutenza® Without Refrigerated Cushion Qutenza® without refrigerated cushion | 49 |
| Qutenza® With Refrigerated Cushion Qutenza® with refrigerated cushion
refrigerated cushion: refrigerated cushion | 50 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 5 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Qutenza® Without Refrigerated Cushion | Qutenza® With Refrigerated Cushion | Total |
|---|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 12 | 49 years STANDARD_DEVIATION 14 | 50 years STANDARD_DEVIATION 13 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 34 Participants | 40 Participants | 74 Participants |
| Sex: Female, Male Male | 15 Participants | 10 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Visual Analogue Pain Scale (Burning Pain)
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?
Time frame: after 1 hour of installation of Qutenza patch
Population: Intent to treat Population (all participants who received a Qutenza patch)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Qutenza® without refrigerated cushion | Visual Analogue Pain Scale (Burning Pain) | 6.99 units on a scale |
| Qutenza® with refrigerated cushion | Visual Analogue Pain Scale (Burning Pain) | 3.78 units on a scale |
p-value: <0.00195% CI: [2.09, 4.31]Mixed Models Analysis