Evaluation of the effect of adding duloxetine to exercise therapy on pain and function of patients with knee osteoarthritis
Design
A semi-experimental clinical trial, with a control group, randomized by a numerical random selection, unblinded, phase 3 on 60 patients
Settings and conduct
The participants are selected from people who come to the sports medicine department of Imam Khomeini Hospital in Sari because of knee pain.
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.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients 40-80 years old
Knee pain during the 3-month period before the first visit more than 14 days per month with an average pain score of Visual Analogue score ≥ 4
Osteoarthritis grade 2 and 3 based on Kallgren-Lawrence
BMI ≤40
Stable knee
Exclusion Criteria:
Deformity of the knee
Spondylolisthesis
Radiculopathy
Inflammatory arthritis
Autoimmune disorder
Septic arthritis
Contraindications for duloxetine
Previous exposure or allergy to duloxetine
Simultaneous use of other drugs affecting the central nervous system
Metabolic diseases
Anticoagulation therapy
pregnancy
Aggressive knee treatments in the last 6 months
Any knee replacement or current infection
Intervention groups
Intervention group: administration of duloxetine (Abidi company) along with exercise therapy
Control group: exercise therapy
For both groups, 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.
Main outcome variables
Primary outcomes: Breif pain Inventory questionnaire, Western Ontario and McMaster Universities Arthritis Index questionnaire
Secondary outcomes include knee extension strength, Timed Up and Go test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230821059204N1
Registration date:2023-10-08, 1402/07/16
Registration timing:prospective
Last update:2023-10-08, 1402/07/16
Update count:0
Registration date
2023-10-08, 1402/07/16
Registrant information
Name
Hanieh Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 6552
Email address
h.ahmadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding duloxetine to exercise therapy on pain and function of patients with knee osteoarthritis
Public title
Effect of Duloxetine in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences, Imam Hospital
Street address
Serah Joibar, the beginning of Vali Asr Highway, the headquarters of Mazandaran University of Medical Sciences and Health Services
City
sari
Province
Mazandaran
Postal code
3397148157
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1402.14934
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
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.
2
Description
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 outcomes
1
Description
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.
2
Description
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.
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Sports Medicine, Mostafavian Clinic, Sari Imam Khomeini Hospital
Full name of responsible person
Hanieh Ahmadi
Street address
Sports Medicine Department, Mostafavian Clinic, Razi No. 3 Alley, Razi St.
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
h.ahmadi@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Department of pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4847193697
Phone
+98 11 3354 3081
Email
pebrahimnejad@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hanieh Ahmadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Mostafavian Clinic, Razi No. 3 Alley, Razi St.
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Fax
Email
H.ahmadi@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hanieh Ahmadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Mostafavian Clinic, Razi No. 3 Alley, Razi St.
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Fax
Email
H.ahmadi@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Elahe Sadat Mahdavian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Mostafavian Clinic, Razi No. 3 Alley, Razi St.
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
dr.e.mahdavian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available