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IRCT20180416039323N4 IRCT 2023-09-18 Artesh University of Medical Sciences Evaluating the efficacy of electroacupuncture in comparison with physiotherapy for reducing pain and disability in soldiers diagnosed with patellar chondromalacia Evaluating the efficacy of electroacupuncture in comparison with physiotherapy for reducing pain and disability in soldiers diagnosed with patellar chondromalacia 2023-08-23 anticipated 40 Complete https://irct.ir/trial/71950 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For random allocating of two groups with the same size of 20 participants (40 patients in total), we used block randomization with different block sizes. The sizes of blocks would be a multiple of 2 and a divisor of 40. At first, the block sizes were selected randomly. Then, for each block, different permutations for equal group size were determined. Finally, one of the permutations was selected randomly. Random numbers were generated in an independent statistical office using Random Allocation Software Ver 1.0.0. 0 (exploratory trials) Chondromalacia patellae. Intervention 1: Intervention group: In the electroacupuncture group, the patients lie on the bed and the treatment is performed at acupuncture points ST34, ST36, ST38, SP9, SP10, and GB34 with 30 x 0.3 mm needles. The needles are kept sterile and with a penetration depth of 10 mm for 20 minutes. Also, an electroacupuncture device made in China is will be used to deliver the current, with a frequency of 5 to 20 Hz and the intensity that is tolerated by the patient without significant muscle twitching. Patients will be prohibited to use any special medicine and only take 325 mg of acetaminophen daily. In both groups, stretching exercises for the calf and hamstring muscles and strengthening the quadriceps muscles will be taught to the patients. Intervention 2: Control group: In the physiotherapy group, patients were treated with 10 sessions of routine physiotherapy with modalities such as infrared, ultrasound and electrical stimulation. Patients will be prohibited to use any special medicine and only take 325 mg of acetaminophen daily. In both groups, stretching exercises for the calf and hamstring muscles and strengthening the quadriceps muscles will be taught to the patients. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Zahra Rezasoltani
501 Hospital, Etemadzade Ave, Fatemi Street
Tehran Iran (Islamic Republic of) 1411718546 +98 21 4382 3476 z.rezasoltani@ajaums.ac.ir Artesh University of Medical Sciences scientific Zahra Rezasoltani
501 Hospital, Etemadzade Ave, Fatemi Street
Tehran Iran (Islamic Republic of) 1411718546 +98 21 4382 3476 z.rezasoltani@ajaums.ac.ir Artesh University of Medical Sciences Iran (Islamic Republic of) The presence of chondromalacia patella on the basis of patient's history The course of the disease more than 2 months Failure to improve with conservative treatment for at least one month 17 years 35 years Female History of lower limb surgery History of serious knee trauma in last 6 months or mild trauma in last 2 months The presence of any evidence of internal or external damage to the knee joint by examination or X-ray History of corticosteroid usage History of any systemic disease such as diabetes, rheumatoid arthritis Scar at the acupuncture site The presence of any deformity in the knee joint such as genovarum/genovalgum M22.4 Chondromalacia patellae Treatment - Other Treatment - Other Intervention group: In the electroacupuncture group, the patients lie on the bed and the treatment is performed at acupuncture points ST34, ST36, ST38, SP9, SP10, and GB34 with 30 x 0.3 mm needles. The needles are kept sterile and with a penetration depth of 10 mm for 20 minutes. Also, an electroacupuncture device made in China is will be used to deliver the current, with a frequency of 5 to 20 Hz and the intensity that is tolerated by the patient without significant muscle twitching. Patients will be prohibited to use any special medicine and only take 325 mg of acetaminophen daily. In both groups, stretching exercises for the calf and hamstring muscles and strengthening the quadriceps muscles will be taught to the patients. Control group: In the physiotherapy group, patients were treated with 10 sessions of routine physiotherapy with modalities such as infrared, ultrasound and electrical stimulation. Patients will be prohibited to use any special medicine and only take 325 mg of acetaminophen daily. In both groups, stretching exercises for the calf and hamstring muscles and strengthening the quadriceps muscles will be taught to the patients. Pain. Timepoint: Before the intervention, 3 months after the intervention. Method of measurement: The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 (‘no pain’) and 10 (‘pain as bad as it could possibly be’). Disability. Timepoint: Before the intervention, 3 months after the intervention. Method of measurement: The Visual Analogue Scale (VAS) measures disability intensity. The VAS consists of a 10cm line, with two end points representing 0 (‘no disability ’) and 10 (‘disability as bad as it could possibly be’). Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire. Timepoint: Before the intervention, 3 months after the intervention. Method of measurement: This questionnaire is designed to measure knee pain, symptoms, motor function problems in daily activities, sports, recreation and quality of life in the knee joint. It has 42 patient-centered questions, which examines 5 concepts related to the patient. The subjects used a 5-point Likert scale. There are five options for each question, and the answers are scored from 0 to 4, and the total points obtained in each sub-group are calculated from 0 to 100 points. The number zero indicates the maximum problem and the number 100 indicates the absence of the problem. Artesh University of Medical Sciences Approved 2023-07-17 Ethics Committees of AJA University of Medical Sciences Imam Reza hospital, Etemad zade street, Fatemi street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)