Effectiveness of electroacupuncture and laseracupuncture in the health of post-covid-19 patients: randomized clinical trial

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: The target sample of the study will be 60 people. The intervention protocol will be guided by the following phases: (1) collection of socioeconomic data and current and previous clinical history of the participant (Appendix C and Annex A); (2) screening and spirometry testing for lung capacity (Appendix B and Appendix C); (3) application of the Beck Anxiety Inventory (Appendix D), the Hamilton Depression Rating Scale (HAM‐D 17 items) (Appendix E) and the revised Piper Fatigue Scale (Appendix F); (5) intervention with acupuncture sessions in the Electro Acupuncture Group and Laser Acupuncture Group; (6) reassessment with the instruments at the end of the period, in all groups. Participants selected by the inclusion criteria will be drawn to compose one of the three groups below. Group 1 ‐ (called Electro Acupuncture Group composed of 20 people) will receive the intervention through transcutaneous electroacupuncture, which does not require the use of a needle, but maintains the stimulation of acupuncture points using small electrodes of 8 mm in diameter, disinfected , with conductive gel, from the NKL® brand, connected in extra‐thin conductor cables, two meters long, stimulated with the following parameters: power of 80 mA, frequency of 2 Hz, in burst type wave (with intervals between stimulus and rest ), pulse width of 200 µs, non‐polarized, alternating wave, intensity at the patient's perception threshold, with a total time of 20 minutes of application, at the points: Neiguan (CS6 or PC6), Zusanli (E36), Zhongwan (VC12 ), Tianshu (S25), Qihai (VC6), Danzhong (VC17), Feishu (B13), Zhongfu (P1). The sessions will take place twice a week, lasting up to one hour each session, for six weeks, totaling 12 sessions for each participant. Group 2 ‐ (called the Laser Acupuncture E02.190.044 CONDITION: Fadiga; Ansiedade; Depressão. E01.370.386.700.485.750 PRIMARY OUTCOME: Improvement in lung ventilatory capacity measured by spirometry, with a total expiratory volume (FVC) index above 60%. Data were collected one week before the start of the intervention, after the end of the sixth (third week) and 12th session (sixth week) after the start of the intervention. SECONDARY OUTCOME: The secondary outcomes evaluated will be the Beck Anxiety Inventory score, with a score greater than or equal to 11, the Hamilton Depression Rating Scale HAM‐D‐17, with a score greater than or equal to 8 and the Piper Fatigue Scale, with a score above 4. Data were collected one week before the start of the intervention, after the end of the sixth (third week) and 12th session (sixth week) after the start of the intervention. INCLUSION CRITERIA: Age between 18 and 59 years; history of positive testing for SARS‐Cov‐2; with new or persistent symptoms since the acute phase of the disease lasting at least two months, unexplained by an alternative diagnosis; that has one or more of the following characteristics: altered spirometry parameters; fatigue score greater than 4; anxiety score equal to or greater than 11; score on the depression scale equal to or greater than 8; not having a contraindication factor for performing electroacupuncture and laseracupuncture; not being on specific clinical treatment for the post‐COVID‐19 syndrome; present agreement with the Free and Informed Consent Form signed in two copies; agree to participate in the proposed tests.
Epistemonikos ID: 94bc1a9cde08d38101e32e664c71f5f90fb429c4
First added on: Oct 02, 2023