Interest of Auriculotherapy in the Treatment of Xerostomia (AURICULOXERO)
|ClinicalTrials.gov Identifier: NCT04222478|
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Xerostomia||Other: Specific auriculotherapy Other: Non-specific auriculotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Interest of Auriculotherapy in the Treatment of Xerostomia.|
|Actual Study Start Date :||December 4, 2019|
|Estimated Primary Completion Date :||April 4, 2023|
|Estimated Study Completion Date :||April 4, 2023|
Experimental: Real Auriculotherapy
Patients benefit from 3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the "protocol of Alimi" at one month intervals.
Other: Specific auriculotherapy
3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the "protocol of Alimi" at one month intervals.
Sham Comparator: Sham Auriculotherapy
Patients are treated according to the same scheme as the experimental group but with semi-permanent needles positioned on non-specific points.
Other: Non-specific auriculotherapy
3 sessions of auriculotherapy with semi-permanent needles on non-specific points.
- Number of patients with improvement of salivation after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group) [ Time Frame: 3 months ]
Show that auriculotherapy (treatment of specific points) is effective in the treatment of xerostomia compared to a "sham" treatment (treatment of non-specific points).
The relative variation of salivary secretion "after treatment" compared to "before treatment" will be judged on the weight of 3 compresses left 5 minutes in the mouth: 2 in front of the openings of Sténon's canal and 1 on the buccal floor (orifice of Wharton's canal).
Salivary secretion is measured by the weight in grams of the compresses left in the mouth.
This measurement is performed at inclusion and after 3 months of treatment. The measurement is made with a jeweler-type precision balance.
- Assess the effect of auriculotherapy on the subjective improvement of salivation [ Time Frame: 3 months ]Specific xerostomia questionnaire at inclusion and 3 months post-treatment (11 questions with 5 response levels (1 = never / 2 = very rarely / 3 = occasionally / 4 = quite often / 5 = very often) to evaluate Xerostomia symptoms).
- Assess the effect of auriculotherapy on the subjective improvement of clinical status [ Time Frame: 3 months ]Global Patient Change Impression (GPCI) questionnaire at 3 months post-inclusion. This questionnaire evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status.
- Assess the effect of auriculotherapy on the dysgeusia, dysphagia, pain or burning sensations [ Time Frame: 3 months ]Simple numerical scales from 0 (best score) to 10 (worst score) at inclusion and at 3 months post-treatment.
- Assess the effect of auriculotherapy on anxiety and depression [ Time Frame: 3 months ]Hospital Anxiety and Depression questionnaire at inclusion and 3 months post-treatment. The HADS consists of 14 items, scored from 0 to 3, with seven questions relating to anxiety and seven questions relating to depression, allowing 2 scores to be obtained. The highest scores indicating more severe symptoms: "normal" cases (0-7 points); doubtful case (8-10 points); certain cases (11-21 points).
- Assess the effect of auriculotherapy on quality of life [ Time Frame: 3 months ]EuroQoL five Dimension questionnaire at inclusion and 3 months post-treatment. This questionnaire is designed for the patient to judge the impact of his state of health on his quality of life according to 5 dimensions (mobility, personal autonomy, daily activities, pain / discomfort and anxiety / depression). Each item has 3 response levels (1, 2 and 3) and the combination of the five digits will represent the patient's state of health. It is supplemented by a quality of life thermometer graduated from 0 (worst quality of life) to 100 (best quality of life).
- Assess the effect of auriculotherapy on the wish to continue treatment [ Time Frame: 3 months ]Patient's desire to continue treatment (question to patient - yes/no response)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04222478
|Contact: Mireille Michel-Cherqui, MD||+33(0)firstname.lastname@example.org|
|Hôpital Forcilles||Not yet recruiting|
|Férolles-Attilly, France, 77150|
|Contact: David GUIGOU, MD email@example.com|
|Principal Investigator: David GUIGOU, MD|
|GHP Saint Joseph||Not yet recruiting|
|Paris, France, 75014|
|Contact: David EBBO, MD firstname.lastname@example.org|
|Principal Investigator: David EBBO, MD|
|Suresnes, France, 92150|
|Contact: Mireille MICHEL-CHERQUI, MD +33(0)146252985 email@example.com|
|Principal Investigator: Mireille MICHEL-CHERQUI, MD|
|Principal Investigator:||Mireille Michel-Cherqui, MD||Hopital Foch|