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IRCT20230821059204N1 IRCT 2023-10-08 Mazandaran University of Medical Sciences Effect of Duloxetine in knee osteoarthritis Evaluation of the effect of adding duloxetine to exercise therapy on pain and function of patients with knee osteoarthritis 2023-10-22 anticipated 60 Complete https://irct.ir/trial/72787 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: The intervention in the first group is the administration of duloxetine (Abidi company) along with exercise therapy. The intervention in the second group is exercise therapy alone, Randomization description: Participants are randomly divided into two groups by numerical random selection process, which are odd numbers for the first group (duloxetine combined with exercise therapy) and even numbers for the second group (exercise therapy). 3 Osteoarthritis of knee. Intervention 1: Intervention group: The prescription of Duloxetine (Abidi Company) is 20 mg per day for one week, then 30 mg per day for the next week, and finally 40 mg per day for the continuation of the study, which is done along with exercise therapy. After the end of 12 weeks of therapeutic intervention, in order to reduce the side effects of drug discontinuation, patients enter the drug tapering phase and receive duloxetine 20 mg for one week, and finally the drug is discontinued. Exercise therapy will be knee and hip isometric exercises and hamstring muscle stretching, and then progress to hip flexion and knee extension isotonic exercises in a sitting position with ankle weights at 50-70% of one repetition maximum . Exercise is home-based, where basic training will be given by the doctor in the clinic, and a booklet containing the form and explanation of how to do the exercises will be provided to the patients as a guide for doing the exercises at home. A phone number will also be provided to patients so that they can contact their doctor if they have any questions or problems about taking medicine or exercising. Exercises are for 4 weeks and 5 times a week. Each exercise is performed in three sets with 10 repetitions until exhaustion. Exercises include (1) seated isotonic exercise for the quadriceps, (2) isometric exercise for the quadriceps, (3) supine isotonic exercise for the hip extensors, (4) isometric seated exercise on the chair for the hip adductors, (5) side-lying isotonic exercise for the hip abductors, (6) low-distance squats, and (7) the seated hamstring stretch. Intervention 2: Control group: Exercise therapy will be knee and hip isometric exercises and hamstring muscle stretching, and then progress to hip flexion and knee extension isotonic exercises in a sitting position with ankle weights at 50-70% of one repetition maximum . Exercise is home-based, where basic training will be given by the doctor in the clinic, and a booklet containing the form and explanation of how to do the exercises will be provided to the patients as a guide for doing the exercises at home. A phone number will also be provided to patients so that they can contact their doctor if they have any questions or problems about taking medicine or exercising. Exercises are for 4 weeks and 5 times a week. Each exercise is performed in three sets with 10 repetitions until exhaustion. Exercises include (1) seated isotonic exercise for the quadriceps, (2) isometric exercise for the quadriceps, (3) supine isotonic exercise for the hip extensors, (4) isometric seated exercise on the chair for the hip adductors, (5) side-lying isotonic exercise for the hip abductors, (6) low-distance squats, and (7) the seated hamstring stretch. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hanieh Ahmadi
Sports Medicine Department, Mostafavian Clinic, Razi No. 3 Alley, Razi St.
Sari Iran (Islamic Republic of) 4816868890 +98 11 3336 6552 H.ahmadi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Hanieh Ahmadi
Sports Medicine Department, Mostafavian Clinic, Razi No. 3 Alley, Razi St.
Sari Iran (Islamic Republic of) 4816868890 +98 11 3336 6552 H.ahmadi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients aged 40-80 years Knee pain more than 14 days per month and the average pain score Visual Analogue score (VAS) ≥ 4 during the 3-month period before the first visit The grade of knee osteoarthritis is 2 and 3 based on the Kallgren-Lawrence classification BMI ≤40 The knee should be stable Good cognitive status The ability to understand the study protocol and the mental ability to answer the questions of the questionnaires Willingness to participate in the study 40 years 80 years Both Deformity of the knee Spondylolisthesis Lumbar radiculopathy Inflammatory arthritis Autoimmune disorder Septic arthritis Any other concomitant disease such as liver and kidney disease Contraindications for duloxetine (current use of monoamine oxidase inhibitors or poorly controlled angle-closure glaucoma) Previous exposure to duloxetine Concomitant use of other drugs that affect the central nervous system (such as benzodiazepines) History of allergy to duloxetine Metabolic diseases Anticoagulation therapy pregnancy History of aggressive knee treatments in the last 6 months Knee joint replacement at any time Current infection in the affected limb M17 Osteoarthritis of knee Treatment - Drugs Treatment - Other Intervention group: The prescription of Duloxetine (Abidi Company) is 20 mg per day for one week, then 30 mg per day for the next week, and finally 40 mg per day for the continuation of the study, which is done along with exercise therapy. After the end of 12 weeks of therapeutic intervention, in order to reduce the side effects of drug discontinuation, patients enter the drug tapering phase and receive duloxetine 20 mg for one week, and finally the drug is discontinued. Exercise therapy will be knee and hip isometric exercises and hamstring muscle stretching, and then progress to hip flexion and knee extension isotonic exercises in a sitting position with ankle weights at 50-70% of one repetition maximum . Exercise is home-based, where basic training will be given by the doctor in the clinic, and a booklet containing the form and explanation of how to do the exercises will be provided to the patients as a guide for doing the exercises at home. A phone number will also be provided to patients so that they can contact their doctor if they have any questions or problems about taking medicine or exercising. Exercises are for 4 weeks and 5 times a week. Each exercise is performed in three sets with 10 repetitions until exhaustion. Exercises include (1) seated isotonic exercise for the quadriceps, (2) isometric exercise for the quadriceps, (3) supine isotonic exercise for the hip extensors, (4) isometric seated exercise on the chair for the hip adductors, (5) side-lying isotonic exercise for the hip abductors, (6) low-distance squats, and (7) the seated hamstring stretch. Control group: Exercise therapy will be knee and hip isometric exercises and hamstring muscle stretching, and then progress to hip flexion and knee extension isotonic exercises in a sitting position with ankle weights at 50-70% of one repetition maximum . Exercise is home-based, where basic training will be given by the doctor in the clinic, and a booklet containing the form and explanation of how to do the exercises will be provided to the patients as a guide for doing the exercises at home. A phone number will also be provided to patients so that they can contact their doctor if they have any questions or problems about taking medicine or exercising. Exercises are for 4 weeks and 5 times a week. Each exercise is performed in three sets with 10 repetitions until exhaustion. Exercises include (1) seated isotonic exercise for the quadriceps, (2) isometric exercise for the quadriceps, (3) supine isotonic exercise for the hip extensors, (4) isometric seated exercise on the chair for the hip adductors, (5) side-lying isotonic exercise for the hip abductors, (6) low-distance squats, and (7) the seated hamstring stretch. The patient's pain level is based on the BPI (Brief Pain Inventory) short pain questionnaire, in the range of 0 to 10. Timepoint: At the beginning of the study before the start of the intervention and at the end of the fourth week and then at the end of the study at the end of the 12th week of the intervention. Method of measurement: The patient will be asked about her/his pain level using the BPI (Brief Pain Inventory) short pain questionnaire in the range of 0 to 10. Estimating pain, stiffness and physical activity in patients with knee osteoarthritis using the WOMAC (The Western Ontario and McMaster Universities Arthritis Index) questionnaire. Timepoint: At the beginning of the study before the start of the intervention and at the end of the fourth week and then at the end of the study at the end of the 12th week of the intervention. Method of measurement: The performance of the patient will be measured using the WOMAC (The Western Ontario and McMaster Universities Arthritis Index) questionnaire, the level of the patient's performance will be measured in the range of 0 to 96. Knee extension strength based on 1-RM (one-repetition maximum). Timepoint: At the beginning of the study before the start of the intervention and at the end of the fourth week and then at the end of the study at the end of the 12th week of the intervention. Method of measurement: Using the knee extension machine, we obtain the maximum weight that a person can lift in the range of 4 to 10 repetitions, then by the formula one-repetition maximum = weight/1- (0.02*repetition) the amount of one-repetition maximum; where weight is the amount of the last weight that the person was able to lift and repetition is the number of repetitions of the lifted weight. Evaluation of patients' functional mobility during daily activities using the Timed Up and Go (TUG) test. Timepoint: At the beginning of the study before the start of the intervention and at the end of the fourth week and then at the end of the study at the end of the 12th week of the intervention. Method of measurement: In the Timed Up and Go test, after familiarizing the person with how to do it, the patient first gets up from a standard chair (the chair does not have handles and the height from the seat of the chair to the floor is 50 cm), then walks 3 meters, then turns and goes back to the chair with the same speed as usual and sits on the chair. The time spent for this movement sequence will be recorded in seconds using a stopwatch. The best time will be recorded after three times of testing. Mazandaran University of Medical Sciences Approved 2023-04-19 Ethics Committee of Mazandaran University of Medical Sciences, Imam Hospital Serah Joibar, the beginning of Vali Asr Highway, the headquarters of Mazandaran University of Medical Sciences and Health Services sari Mazandaran Iran (Islamic Republic of)