Authors
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Universidade Brasil -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2021
INTERVENTION: H02.004 It was performed a longitudinal case reports study, randomized, single‐blinded, placebo‐controlled design with an experimental and qualitative / quantitative character. The research protocol was carried out using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) version 5‐point Likert scale with a range of 0‐96. Visual Analogue Scale (VAS), the assessment of knee rotations of joint measured by goniometry, edema measured by perimetry of the affected knees and the inflammatory and anti‐inflammatory cytokine concentrations in the saliva. The study was carried out over 30 days including an initial screening procedure to determine the eligibility of each subject to take part in the study, pre‐treatment, treatment and post‐treatment –in total it was performed 3 sessions. Data collection was performed at four points: The first evaluation (EV0 – pre‐treatment) was done before the therapeutic intervention (where the patient answered the questionnaires and the knee goniometry and perimetry was performed); EV1 (3h after treatment); EV2 (3 days after treatment); and EV3 (30 days after treatment) where the patients answered the same questionnaires and the goniometry and perimetry were performed again. Twelve male and female patients aged between 60‐80 years with KOA were randomly divided into 3 groups (Table 1). The patients participating in the study came from the Center for Specialties and Rehabilitation, in the city of Praia Grande, state of São Paulo, Brazil. Treatments: In Control group, the patients were treated with acupuncture needles (0.25 mm in diameter and 40 mm of length) on false acupuncture points (sham points‐ Points in muscle regions near the knee joint, in the insertion of the femoral rectus muscle and around gastrocnem CONDITION: CID 10 ‐ M19.8 knee osteoarthritis SECONDARY OUTCOME: Presentation of Secondary outcome ‐ Long term evaluation ‐ The intervention consisted of 3 twenty‐minutes acupuncture sessions (20 minutes each) in 3 different days: at the beginning of treatment, after 3 days (72hs) and after 30 days. After a month of treatment, all patients will report the symptoms mentioned in the previous evaluations. Presentation of Secondary outcomes : Cytokines Analysis Cytokines are important mediators of the immune response, acting on the regulation, duration and intensity of this response. In this study we did not find any statistical significance between the treatments, only in IL‐6 cytokines we find a trend of association, but the variation between patients were very high leading a loss of significance when compare all the groups together. ; ; INCLUSION CRITERIA: The individuals included in study must have a diagnosis of bilateral knee Osteoarthritis documented, with or without indication of total knee prosthesis but who have not yet been prosthetic; aged 60 years or over and equal to or less than 80 years deity. Participating individuals must be able to walk (gait), with or without support, so that it is possible to carry out the physical tests relevant to the study. PRIMARY OUTCOME: presentation of primary outcomes : Pain, stiffness, and physical functioning of the joints also were evaluated by The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used, proprietary set of standardized . questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC has also been used to assess back pain, rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia. It can be self‐administered and was developed at Western Ontario and McMaster Universities in 1982.; ; The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68).[2] Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties.[3] The questions on the WOMAC are a subset of the questions of the Hip disability and osteoarthritis outcome score (HOOS).[4] Thus, a HOOS survey may also be used to determine a WOMAC score.; The results showed a statistically difference in WOMAC pain score between pre‐treatment and 30 days after treatment in CO group, showing a lower score after 30 days of treatment (p=0.049). However, CA group showed statistically significant improvement in 3 days after the treatment (p=0.049) (Figure 4). The results in EA group did not show statistically significances. Presentation of primary outcomes: were used followed methods : Western Ontario and Pain and Functional Scores were evaluated to verify the primary effects ‐ pain ( goniometry) relief and edema (perimetry). To evaluate this informations specifically were used : McMaster Universities Osteoarthrites index questionary (WOMAC); evaluation of goniometry, perimetry and VAS pain were used. ; Results : The control and convencional acupuncture groups obtained better results in the pain relief and short‐term edema (up to 7 days after treatment) than Electro Acupuncture group. EA group was more effective in long‐term for pain, edema and range of motion (30 days after treatment) (p <0.05). We could not find any statistically significant results in cytokine titration. Conclusions: The current study indicates that EA treatment combined to mixed frequencies promoted short‐term and long‐term pain reduction in elderly patients with KOA.
Epistemonikos ID: b78119e175dee3c052bec184fe0f423bb12d44df
First added on: Aug 25, 2024