Efficacy of acupuncture on quality of life, functional performance, shortness of breath, and lung function in patients with Pulmonary emphysema: randomized clinical trial

INTERVENTION: Acupuncture: There will be 48 acupuncture sessions using the traditional Chinese medicine needling style, based on the literature in the area and clinical consensus, the selection of needling points will not be changed throughout the treatment and the needling will be manual. After the insertion of needles, manipulation will be carried out with adequate stimulus to obtain Dé Qi (acupuncture sensation), at determined and pre‐established points for all patients. The procedure for each session will be as follows: Patients in the supine position (lying on their back) will have the needles inserted 30 minutes after the last needle is inserted. Needles will be inserted into the acupoints: Ren Mai 17 and 06 (RM 17 and 06), lung 5 (P5 or LU5 bilateral), lung 7 (P7 or LU7 bilateral), stomach 36 (S36 or ST36 bilateral), spleen‐pancreas 10 (BP10 or SP10 bilateral). Acupuncture needles made of stainless steel, 0.25 mm gauge and 3 cm long, approved by the National Health Surveillance Agency (ANVISA) will be used. The evaluation methods will be as follows: mini‐cog The Mini‐Cog will be applied only in the first phase of the experiment, as an inclusion criterion for individuals over 65 years of age. It consists of a three‐word memorization task and a clock drawing task. The individual should be able to remember the three words after drawing, scoring 1 for each word they remember and 2 for the correct clock drawing. The Mini‐Cog has a total score of 5 points. Results ranging from 3 to 5 points are considered normal. Dual Energy Radiological Absorption (DEXA) Total body mass, fat mass, lean mass, bone mineral density and height will be evaluated by means of Dual Energy Radiological Absorbance (DEXA) (Lunar Radiation Corporation, Madison, Wi E02.190.044 CONDITION: Chronic Obstructive Pulmonary Disease; Emphysema PRIMARY OUTCOME: Quality of life ‐ It will be evaluated through the PGI and SGRQ, both will be applied at baseline with 8 weeks of treatment and at the end with 16 weeks of treatment.; ; Patient Generated Index (PGI); The PGI is completed in three steps: (1) individuals identify the five most important areas of their life affected by the disease, in this case chronic obstructive pulmonary disease; (2) subjects rate how much each area was affected by COPD using a scale of 0 to 6, where 0 is the worst imaginable and 6 is exactly how they would like it to be; (3) individuals now imagine they have 10 “tokens” to spend on improving selected areas and allocate these “tokens” to areas according to their own priority. An overall index is calculated by multiplying the ratings for each area in step 2 by the proportion of tokens given to that area in step 3, which are then added together to produce an index where higher scores indicate higher QoL.; The PGI will be used to assess QOL.; ; Saint George's Respiratory Questionnaire (SGRQ); The SGRQ addresses aspects related to three domains: symptoms, activity and psychosocial impacts that respiratory disease inflicts on the patient. Each domain has a maximum possible score; the points for each answer are added up and the total is referred to as a percentage of this maximum. A total score is calculated from 0 (no health impairment) to 100 (maximum health impairment). In addition to the total score, there is also a score for each domain: symptoms, activity and impact, which are also scored from 0 to 100. Values ??above 10% reflect an altered QOL in that domain. Changes equal to or greater than 4% after an intervention, in any domain or in the total sum of points, indicate a significant change in the patients' QoL.; The SGRQ will be used to assess QOL. SECONDARY OUTCOME: Dyspnea ‐ Dyspnea will be evaluated through CAT and LCADL questionnaires and by the 6MWT functional test, for which they will be applied at baseline, with 8 weeks of treatment and 16 weeks of treatment. ; ; London Chest Activity of Daily Living (LCADL) ; The London Chest Activity of Daily Living (LCADL) scale has four domains (personal care, household activities, physical activities and leisure activities), with 15 questions in total, with the purpose of assessing the limitation of activities of daily living (ADL) in COPD patients. Each question of the domains receives a score, indicated by the patient, which varies from 0 to 5, with the highest value representing the maximum inability to perform ADL due to dyspnea. The total score can range from 0 to 75 points, and the higher the value, the greater the limitation in ADL. The scale also has question 16, which refers to a specification of ADL impairment due to dyspnea, in any situation, and the patient must answer this question by ticking one of the three alternatives: "a lot", "little" or "not at all". ". ; Six‐minute walk test (6MWT) ; To assess functional performance, the 6MWT will also be applied, according to the recommendations of the American Thoracic Society. The test will be carried out in a 30‐meter corridor, on a flat surface, in which the subjects will be instructed to walk as fast as possible without running, for si Xminutes. You will be allowed to rest during the test and resume walking as soon as possible. During the walk, the examiner will give verbal stimulation every minute, always using the same tone of voice and the standardized phrase: “you are doing very well”. The subject will be instructed to interrupt the test if he presents pain in the lower limbs, tachycardia, dizziness or any other symptom of discomfort. Immediately before and after the test, systemic blood pressure (BP), heart rate (HR), oxygen saturation (SpO2) and level of dyspnea and lower limb fatigue (Borg scale) will be measured. Two tests will be performed with a 30‐minute interval between them, and the test in which the participant has walked the longest distance will be used for analysis. If the difference in distance walked between the two tests is greater than 10%, a third test will be performed. It is worth noting that for individuals with COPD, the average increase of 30 meters in the distance covered on the 6MWT after pulmonary rehabilitation indicates a minimal significant increase. ; COPD Assessment Test (CAT) ; The CAT consists of eight items, called cough, phlegm, chest tightness, shortness of breath, limitations in home activities, confidence in leaving home, sleep and energy. For each item, the patient chooses only one answer option, whose score varies from zero to five. At the end of the test, the scores of all responses are added up and, thus, the clinical impact of COPD is evaluated according to the stratification score of the CAT development and validation study. Results vary according to the range of scores obtained, classified as follows in relation to clinical impact: 6‐10 points, mild; 11‐20, moderate; 21‐30, severe; and 31‐40, very severe. Pulmonary function will be evaluated through spirometry, which will be performed at baseline, after 8 weeks of treatment and after 16 weeks of treatment. ; ; Spirometry (from the Latin spirare = to breathe + metrum = measure) is the measurement of the air that enters and leaves the lungs. Spirometry is a test that allows the diagnosis and quantification of ventilatory disorders. It will be used in the study in order to assess the individual's pulmonary function and characterize the sample studied according to the GOLD criteria. ; Spirometry will be performed using the MIR Spirometer, Model Minispir, manufactured by MIR Medical International Research (Italy), with the individual sitting with trunk support, with arms along the body, using a nose clip. You will be asked to place the mouthpiece above the tongue and close the mouth tightly around it; at the researcher's command, the individual will make a deep inspiration until the total lung capacity (TLC) followed by a “fast and prolonged” forced expiration, until the examiner's end signal, when the patient still with the mouthpiece in the mouth will make a maximum inspiration. At least three measurements will be carried out, three of which are acceptable and two reproducible. For evaluation, the best values ??will be recorded, according to the I Consenso Brasileiro de Spirometria (“I Consenso de Espometria.”, 1996). Will be analyzed: forced vital capacity (FVC); forced expiratory volume in the first second (FEV1); forced expiratory flows at 25%, 75% and 25‐75% of the FVC curve; peak expiratory flow (PEF), and the ratio between FEV1 and FVC (FEV1/FVC) and inspiratory capacity (IC), which is the amount of air that can be inhaled from resting expiratory level to TLC and the ratio between maximal voluntary ventilation and minute volume (VE/MVV). These parameters will be expressed in absolute values ??and percentage of the predicted, according to the GOLD reference values. ; The spirometer will be calibrated daily prior to the tests. Calibration will involve measuring the output of the spirometer, the sensitivity of the recording device, or generating a software correction factor, and therefore will involve tuning the equipment for performance within certain limits. For this purpose, a 3L syringe supplied by the manufacturer will be used along with the equipment. ; Spirometry will be used to confirm the diagnosis according to GOLD, to characterize the sample and to evaluate the response to the acupuncture intervention. INCLUSION CRITERIA: Clinical diagnosis of COPD according to GOLD; ability to offer written authorization or indicate a person to read the Free and Informed Consent Form (ICF), with the agreement of the research participant; there will be no age limit, however individuals who are over 65 years old must have preserved cognitive function according to the Mini‐Cog (individuals under 65 years old will not do the Mini‐Cog); clinical stability in the month prior to the beginning of the protocol.