The aim of the study is to show that auriculotherapy is effective in the treatment of xerostomia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the "protocol of Alimi" at one month intervals.
3 sessions of auriculotherapy with semi-permanent needles on non-specific points.
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest, Brittany Region, France
RECRUITINGHôpital Forcilles
Férolles-Attilly, France
RECRUITINGGHP Saint Joseph
Paris, France
NOT_YET_RECRUITINGNumber of patients with improvement of salivation after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)
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.
Time frame: 3 months
Assess the effect of auriculotherapy on the subjective improvement of salivation
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).
Time frame: 3 months
Assess the effect of auriculotherapy on the subjective improvement of clinical status
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.
Time frame: 3 months
Assess the effect of auriculotherapy on the dysgeusia, dysphagia, pain or burning sensations
Simple numerical scales from 0 (best score) to 10 (worst score) at inclusion and at 3 months post-treatment.
Time frame: 3 months
Assess the effect of auriculotherapy on anxiety and depression
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Hôpital Foch
Suresnes, France
RECRUITINGHospital 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).
Time frame: 3 months
Assess the effect of auriculotherapy on quality of life
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).
Time frame: 3 months
Assess the effect of auriculotherapy on the wish to continue treatment
Patient's desire to continue treatment (question to patient - yes/no response)
Time frame: 3 months