Acupuncture evaluation in treatment of pain related to articulation of the chewing region.

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2017
INTERVENTION: H02.004 Procedure/surgery The sample will be divided into two groups of 30 patients ‐ Intervention and Control, selected randomly by lot: the patient's sample files will be numbered and the corresponding numbers will be recorded in folded papers of the same size and deposited in a box of Cardboard. After being mixed, one by one of the papers were removed from the box and in an interleaved form, the numbers contained therein will be allocated to the intervention and control group, respectively, until all the medical records are taken into account. The intervention group will undergo treatment with acupuncture and auriculotherapy immediately after selection in the sample and the control group will begin treatment with acupuncture and auriculotherapy within approximately 5 weeks after the initial evaluation. Acupuncture and Auriculotherapy Intervention group The methodology to be used for therapy with acupuncture and auriculotherapy follows the recommendations of the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) (MACPHERSON et al, 2010). Logical basis of acupuncture: • Acupuncture style: Western medical acupuncture and auricular acupuncture. Western medical acupuncture is a therapeutic mode of insertion of filiform needles, being an adaptation of traditional Chinese acupuncture using the current knowledge of anatomy, physiology, pathology and evidence‐based medicine (WHITE and EDITORIAL BOARD OF ACUPUNCTURE IN MEDICINE, 2009). • The choice of auriculotherapy was based on its anatomical location and innervation that relates to the face and temporomandibular region and also in clinical studies that show its effectiveness for pain and anxiety (WANG; Ploquin, Kain, 2001; Teixeira, 2007) . Needle details: • nine needles will be used in the body and face and five needles in the ear per session, per patient, as described below: • Effective points in body homeostasis and pain relief in general: BP6 (Sanyinjiao), E36 (Zusanli), IG4 CONDITION: C05.500.607.221.897.897 Temporomandibular Joint Dysfunction Syndrome ; C05.500.607.221.897.897 SECONDARY OUTCOME: Subjective analysis of stress and anxiety ; For the subjective assessment of stress and anxiety, the Lipp Adult Stress Symptom Inventory (ISSL) and the Beck Anxiety Inventory (BAI) will be used. The inventories will be applied by two experienced psychologists in the area, individually and scheduled, in a room with acoustic protection, specially prepared for qualitative research. ; To calculate the impact of oral health on quality of life through OHIP‐14, the so‐called additive method will be used, in which the fourteen questions will have five response options according to the following Likert scale: zero for never, one for rarely, Two for sometimes, three for repeatedly and four for ever. At the end, all the values ??assigned to the answers will be summed up and the scores can range from zero to fifty‐six. The higher the score, the greater the perception of the impact of oral health by the examined ones. ; This multiplication results in a maximum value variation for each question from 1.36 to 2.64 points. The sum gives a final score of all questions with values ??ranging from 0 to 28 points. The higher the score presented, the greater the negative repercussion on the quality of life ; ; The results obtained will be calculated and expressed in ngl / l for saliva and pg / mg for hair PRIMARY OUTCOME: The intensity of spontaneous pain (joint at rest) and during masticatory function will be assessed by Visual Analogue Scale (EVA) before and after each acupuncture session for the intervention group and at the beginning and after the five‐week waiting period for the Of the control group. The pain intensity at rest will be measured first, followed by pain at function. Spontaneous pain was defined as pain intensity without stress on the joint and mandibular muscles and would be measured in a mandibular rest position where the mandibles were in the neutral position without any contact between the mandible and upper teeth. Pain in function was considered as the intensity of pain during chewing. Participants were instructed to chew a chewing gum using both sides of their jaws for 60 seconds and immediately assess their pain. The EVA will be used to quantify pain subjectively, since it is a numerical scale from zero to ten, which indicates the severity of the symptom perceived by the patient. The absence of pain corresponds to the numerical value zero, a moderate / mild pain corresponds to the numeric values ??of one to three, a regular / uncomfortable pain corresponds to the numeric values ??of four to six, a strong / distressing pain corresponds to the numerical values ??of seven to Eight, a horrible / unbearable (excruciating) pain corresponds to the numerical values ??of nine to ten ; ISSL is an instrument that was developed by Lipp, the author based on Hans Selye's three‐phase stress model, but added a new phase, the quasi‐exhaustion, thus forming the four‐phase model of stress, divided into three parts: The first one verifies the existence or not of stress in the subject; The second investigates the stage of stress in which the person is (alert, resistance, near‐exhaustion or exhaustion) and the third, the area of ??greatest manifestation of symptoms ‐ physical or psychological. This inventory classifies the symptoms into: physical, psychological and physical / psychological simultaneously. The BAI is a self‐reported questionnaire with twenty‐one multiple choice questions used to measure the severity of an individual's anxiety. The BAI consists of twenty‐one questions about how the individual has felt in the last week, each question presents four possible responses and the one that most closely resembles the individual's mental state should be flagged. The possible answers are: no, slightly: did not bother me much, moderately: it was unpleasant, but I could bear, severely: I barely supported it, the BAI can have a maximum result of sixty‐three and the categories are: zero‐seven: degree Minimal anxiety, eight‐fifteen: mild anxiety, sixteen‐twenty‐five moderate anxiety, twenty‐six‐sixty‐three: severe anxiety. The instrument chosen to evaluate quality of life will be the simplified form of the Oral Health Impact Profile (OHIP‐49), composed of fourteen items, under the name of Oral Health Impact Profile ‐ short form (OHIP‐14). This OHIP‐14 index, already translated into Portuguese, presents two items in each of the following dimensions: functional limitation, physical pain, psychological discomfort, physical incapacity, psychological incapacity, social incapacity and social disadvantage ; The instrument will be applied at two different times for each group: group before the first and last acupuncture session for the test group and at the beginning and after the five‐week waiting period for treatment. Before applying the questionnaire as an interview, the patient will receive guidance from the researcher on the application of the questionnaire in the form of an interview. The objective evaluation of stress levels will be performed by the analysis of salivary and capillary cortisol concentration for both groups. INCLUSION CRITERIA: Agree to sign the consent form;Diagnosed with muscular TMD, joint or mixed, according to the criteria of the RDC‐TMD;In the age group between 20‐65 years;Both sexes;Symptomatic pain for more than six months
Epistemonikos ID: 85455361737025ebd153d47c2ca3086c46aa41e1
First added on: Aug 23, 2024