Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202311507335269 Date of Approval: 09/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of metformin phonophoresis and exercise therapy on knee pain, range of motion, and function in knee osteoarthritis
Official scientific title Effects of metformin phonophoresis and exercise therapy on knee pain, range of motion, and function in knee osteoarthritis
Brief summary describing the background and objectives of the trial Osteoarthritis (OA) is a highly prevalent musculoskeletal disorder that affected 303 million people globally in 2017 (Kloppenburg and Berenbaum, 2020). It can affect any joint, but preferentially affects the knee, hands, hip, and spine (Kloppenburg and Berenbaum, 2020). The prevalence of OA ranges from 3.8 to 70% depending on different regions of the world, and it has been reported to affect 1 million people in Iraq. Beyond 50, women are more likely to have OA than men of the same age. The prevalence of KOA has been reported to be 12% in those over the age of 55 years (Amin et al., 2019). Up to date, there is no standard treatment or strict guidelines for the management of osteoarthritis. There is a need for a less invasive treatment modality with better effects on pain and the prevention of cartilage degradation. Recently, metformin has received increasing attention due to its potential anti-proliferative properties. Due to its properties, metformin has been tested for its efficacy in treating KOA in an in vitro trial (Siddiq et al., 2022). Up to our knowledge, no previous study assessed metformin phonophoresis and its possible effect on osteoarthritic patients as a new modality to treat OA patients, suggesting suppression of intra-knee MMP activity and alleviation of OA symptoms. Thus, the main objectives of this study are to evaluate the potential effects of metformin administration using phonophoresis on knee pain, knee range of motion (ROM), and functional performance in patients with knee osteoarthritis
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 10/11/2022
Actual trial start date 15/12/2022
Anticipated date of last follow up 22/07/2023
Actual Last follow-up date 20/09/2023
Anticipated target sample size (number of participants) 85
Actual target sample size (number of participants) 78
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Metformin phonophoresis US a treatment duration of 10 min per session for three sessions a continuous mode at a frequency of 1 MHz (deep injury) ; and an intensity of 1 W/cm²(Ahmed et al., 2019, Oktayoğlu et al., 2014, Luksurapan et al., 2013) up weekly for 4 weeks using (1.2% metformin gel) phonophoresis . 3 times per week for 4 weeks (1.2% metformin gel) phonophoresis was used on the medial tibiofemoral joint by using an a coupling medium in circular movements with the probe at right angles in to 5 cm depth. 26
Experimental Group metformin phonophoresis added to conventional exercise program 3 times per week for 4 week Phonophoresis using MF was applied to the medial tibiofemoral joint by using an a coupling medium in circular movements with the probe at right angles in to 5 cm depth and added to conventional exercise program for knee osteoarthritis 26
Control Group US with neutral non drug gel 3 sessions per week for 4 weeks US with neutral gel was applied to the medial tibiofemoral joint by using an a coupling medium in circular movements with the probe at right angles in to 5 cm depth . 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. unilateral moderate knee OA based on the American College of Rheumatology criteria (ACR) 2. Age of the subjects was between 40-60 years . 3. Body mass index (BMI) was 18.5-29.9 kg/m2. 1. Rheumatoid arthritis 2. Severe knee OA 3. Thrombosis of the lower limbs 4. Previous surgery on the knee joint 5. Previous fracture of the lower extremity with knee joint involvement 6. Any contraindications or precautions for the use of ultrasound (e.g., infection, heart problems, pacemaker, metal implants, open epiphysis, pregnancy 7. Thrombophlebitis Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/12/2022 Institutional Review Board Approval of Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
Giza Giza 11511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome knee pain , knee function before - after 2 weeks - after 4 weeks
Secondary Outcome knee flexion and extension ROM before , after 2 weeks , after 4 weeks
Secondary Outcome physical performance before , after 2 weeks , after 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Baghdad Medical City hospital in Iraq Str. 60 Near Al Imamain Al-Kadhimain Medical Baghdad City 10064 Iraq
FUNDING SOURCES
Name of source Street address City Postal code Country
non Iraq Baghdad City Iraq
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university Ahmed el zayad - Giza Giza 11511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MARWA ABED marihan_aziz@cu.edu.eg +9647703482730 Baghdat
City Postal code Country Position/Affiliation
Iraq Iraq Master student at department of musculoskeletal disorder and its surgery at faculty of physical therapy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Marihan Aziz marihan_aziz@cu.edu.eg +201201227971 Maadi
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Musculoskeletal System Disorders and their Surgeries Faculty of Physical at Cairo university. PhD.degree of orthopedic physical therapy
Role Name Email Phone Street address
Public Enquiries Elsadat Soliman sadatsaad@yahoo.com +2011128911820 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of Physical Therapy Department for Musculoskeletal System Disorders and their Surgeries Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after identification (text, tables, figures, and appendices), is available in the study protocol document. The data will be available from the beginning and ending of the article. Researchers who provide a methodologically sound proposal use the type of analysis in order to achieve the aims of the approved proposal. A proposal may be submitted up to 36 months following article publication. Study Protocol The data will be available from the beginning, after 12 months of study completion, till 5 years after publication ● Descriptive statistics was used to determine mean and SD of the Participants. Descriptive statistics and ANOVA were carried out for assessment of the mean age (years), weight (Kg), height (cm), and BMI (kg/m2) of the three groups. ● Test of Chi squared was performed for evaluation of allocation of sex among groups. ● In advance of analysis, test of Shapiro-Wilk was employed to check the data normality. Variance’s homogeneity test of Leaven was performed to evaluate among groups homogeneity which revealed normally distributed data with variance homogeneity. Boxplot showed no data outliers. ● MANOVA of mixed 3 x 3 design was carried out to examine the impact of treatment (between groups), time (pre versus after 2weeks and post after 4 weeks) besides the interaction impact on values of mean of knee ROM, function, physical performance ● Kruskal Wallis test (between groups) and Friedman test for time (pre versus after 2weeks and post after 4 weeks) were used for pain intensity ● The significance level for all statistical examinations appointed at p < 0.05.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information