Effect of analgesic and anti-inflammatory current on muscle strengthening in patients with knee arthrosis. Blind randomized clinical trial

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2021
INTERVENTION: E05.723.402 Patients will be submitted to 12 treatment sessions, 2 sessions per week, for 6 weeks. The sessions will take place individually, in a private room with adequate lighting and air conditioning. The treatment programs will be applied by a physiotherapist with at least three years' experience in clinical practice with patients with knee osteoarthritis. In addition, training will be carried out, before the study begins, to familiarize and standardize the proposed treatment programs. The evaluations will take place on the days before (0), 14, 28, 42 and 72 (30‐day follow‐up) after the end of the treatment, using the following instruments: questionnaires ‐ Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Lequesne algofunctional index, numerical pain scale, algometry, manual dynamometer, in addition to the functional tests ‐ Time Up Go, 6‐minute walk test. The work will be developed with 153 patients of both sexes aged 50 to 70 years who present with knee pain, functional reduction in the last three months and a possible sample loss of up to 15% was considered, therefore, 51 patients will be needed per group.. CONDITION: Osteoarthritis; Resistance Training; Electric Stimulation PRIMARY OUTCOME: Pain Assessment; Pain will be assessed using two instruments: algometry and numerical pain scale (END). The numerical pain scale is simple and easy to measure, consisting of a sequence of numbers, from 0 to 10, in which the value 0 represents “no pain” and the numeral 10 represents “worst pain imaginable”. The degree of pain will be assessed when the individual is at rest and 10 minutes after the end of the formulated tests. The END will be applied every day of the interventions. Algometry is a test to analyze the patient's pain threshold, it is a device that contains a small piston that records the pain in relation to the pressure applied to a certain location in the body. Algometry will be designed in the patient's hand as an explanatory test, to understand the difference between pressure and painful stimulus, being instructed to report the moment when the equipment pressure begins to bother and generate painful stimulus. The positioning to perform the algometry will be with the patient sitting with the knees flexed at 90º, with eyes closed, with the following protocol: six points around the knee in random order, base and apex of the patella, medial and lateral ends of the patella and medial and lateral joint interline. In addition, it will be applied at a point in the medial heel region between one and two degrees lateral to the medial malleolus, to assess a possible change in sensitivity at the central level. INCLUSION CRITERIA: Patient with knee osteoarthritis (Kellgren and Lawrence classification grades II and III); Age between 50 and 70 years and; Pain equal to or greater than 3 at rest and / or equal to or greater than 5 after a 6‐minute walk test; Whether a bilateral OA will be considered the side most affected. SECONDARY OUTCOME: Disability; Assessed using a questionnaire called WOMAC (Western Ontario McMaster Universities Osteoarthritis Index). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire is validated and adapted for the Brazilian population, with excellent reliability. It aims to relate the functional capabilities and limitations due to the physical aspect of each patient. Composed of three categories, the first being composed of five questions responsible for evaluating pain intensity. The second consists of two questions responsible for assessing joint stiffness in the last 72 hours. And the third category consists of seventeen questions responsible for assessing physical function, relating the patient's ability to move and take care of himself. Your final score is classified as: none, light, moderate, strong, very strong.
Epistemonikos ID: 3bb3ca6c080bc13be14b5bd67b813ce4e8519ec7
First added on: Aug 25, 2024