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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230821059204N1
Enrollment
60
Registered
2023-10-08
Start date
2023-10-22
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of knee. Osteoarthritis of knee

Interventions

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 o

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHanieh Ahmadi

Mazandaran University of Medical Sciences

H.ahmadi@mazums.ac.ir+98 11 3336 6552

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026