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QUTENZA® is a skin patch with a high concentration of capsaicin (8%) which is the component responsible for spicy peppers. QUTENZA® is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other analgesics. Acute pain experienced during and after the procedure can be relieved by local cooling methods and oral analgesics but the pain remains intense. The hypothesis is that hypnosis via a standardized hypnotic message would increase the local tolerance of the treatment when applying the patch QUTENZA®. To date, there are no studies that can confirm or refute this hypothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 | Experimental | Patients, followed in the institut and for whom a new application of QUTENZA® is required, will receive standard care. |
|
| arm 2 | Active Comparator | Patients, followed in the institut and for whom a new application of QUTENZA® is required. Patients will receive QUTENZA® according to standard procedure with a standardized hypnotic message |
|
| arm 3 | Placebo Comparator | Patients, followed in the institut and for whom a new application of QUTENZA® is required. Patients will receive QUTENZA® according to standard procedure with a music therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QUTENZA® | Drug |
| ||
| hypnotic message |
| Measure | Description | Time Frame |
|---|---|---|
| Compare pain induced by patch QUTENZA® | Pain will be evaluated by a numerical scale before, just after, and after installation of the patch | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Compare anxiety induced by patch QUTENZA® | Anxiety will be evaluated by a numerical scale before, just after, and after installation of the patch | 1 day |
| Compare the real time of application of the patch |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CRETINEAU Nathalie, Md | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34044838 | Result | Etienne R, Laurent M, Henry A, Bioy A, Salleron J, Schohn CH, Cretineau N. Interest of a standardized hypnotic message for the reduction of pain and anxiety in cancer patients treated by capsaicin patch for neuropathic pain: a randomized controlled trial. BMC Complement Med Ther. 2021 May 27;21(1):154. doi: 10.1186/s12906-021-03329-8. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009443 | Neuritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| Other |
|
| music therapy | Other |
|
| 1 day |
| Determine the number of patients who listened the message in totality. | 1 day |
| Compare the percentage of patients with a sensation of time distortion | 1 day |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |