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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202105910356758 Date of Registration: 21/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Ultrasound Therapy on Serum Levels of Cartilage Oligomeric Matrix Protein inSymptomatic Knee Osteoarthritis patients.
Official scientific title Effects of Six Weeks Ultrasound Therapy on Serum Levels of Cartilage Oligomeric Matrix Protein in Symptomatic Knee Osteoarthritis patients in a Nigerian population.
Brief summary describing the background and objectives of the trial Knee Osteoarthritis (OA) is one of the most common musculoskeletal disorders seen in the outpatient orthopaedic and physiotherapy clinics. Clinical symptoms of knee OA include pain and activity limitation. Cartilage Oligomeric Matrix Protein (COMP) and Hyaluronic Acid (HA) are documented biomarkers of knee OA and their serum levels are increased in affected persons. There is paucity of data on the efficacy of physiotherapy interventions in reducing serum levels of COMP and HA in knee OA.The aim of the study is to determine the effect of 6 weeks ultrasound (US) therapy on serum COMP (sCOMP) level in knee OA patients. The specific objectives are to determine: (i) the effect of six weeks ultrasound therapy on knee pain intensity, knee stiffness and physical function and (iii) the relationship between COMP, and knee pain intensity in knee OA patients after six weeks of US therapy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SWUST
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 20/05/2021
Actual trial start date 20/05/2021
Anticipated date of last follow up 20/08/2021
Actual Last follow-up date 06/07/2021
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Exercise therapy Each patient in the control group had isometric and isotonic quadriceps Strengthening Exercises 4times weekly Six consecutive weeks for each patient Quadriceps Strengthening Exercises: All the subjects in this group will have isometric and isotonic quadriceps strengthening exercises. The isometric quadriceps strengtheningprotocol (Miyaguchi, 2003) will be adopted for this study. The isotonic quadriceps strengthening exercises adopted for this study will be the oxford technique. The subjects will wear light t- shirts and shorts that will expose their thighs for the exercise therapy. 1. Quadriceps strengthening (isometric). The subjects will perform this exercise in lying. With the other knee slightly flexed, and supported with pillows, the subjects will be instructed to hold the limb to be exercised in full extension and the foot lifted 20cm off the exercise plinth with the ankle in dorsiflexion. The subjects will then told to hold the limb in that straight position for a slow 100 Active-Treatment of Control Group
Experimental Group Pulsed Ultrasound therapy 15 minutes of pulsed ultrasound therapy four times a week Six consecutive weeks Each subject in the ultrasound group will be asked to lie supine on a treatment couch and made comfortable. The knee to be treated will be slightly flexed with a soft pillow and positioned closer to the researcher. The researcher will clean the knee properly with alcohol based swab to minimize the potential transmission of microbial agents between the subjects (Schabrun et al, 2006).The researcher will then put some aquasonic coupling gel on the knee to be treated and then presses the ultrasound head (also known as transducer) against the knee, moving the transducer head in small circular directions over the antero- medial and antero-lateral sides of knee. The subjects will also be asked to report any discomfort felt during the treatment session. At the end of each treatment session, the gel on the subjects’ knee will wiped off and the transducer will also cleaned too and placed in the transducer pouch. Each subject will received ultrasound therapy four times a week for six weeks. [ ] Quadriceps Strengthening Exercises: All the subjects in both groups will have isometric and isotonic quadriceps strengthening exercises. The isometric quadriceps strengtheningprotocol (Miyaguchi, 2003) will be adopted for this study. The isotonic quadriceps strengthening exercises adopted for this study will be the oxford technique. The subjects will wear light t- shirts and shorts that will expose their thighs for the exercise therapy. 1. Quadriceps strengthening (isometric). The subjects will perform this exercise in lying. With the other knee slightly flexed, and supported with pillows, the subjects will be instructed to hold the limb to be exercised in full extension and the foot lifted 20cm off the exercise plinth with the ankle in dorsiflexion. The subjects will then told to hold the limb in that straight position for a slow count of 5 to 10 and gently lowered on the plinth. The procedure will be repeated ten times for each session. The same will be done for the ot 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following categories of individuals were included in the study: 1. Patients referred to the researcher by the attending orthopaedic surgeons at Nnamdi Azikiwe University Teaching Hospital Trauma Centre Oba. 2. Patients of either sex aged 46 -65 years old (The American College of Rheumatology). 3. Patients with at least six months history of knee osteoarthritis. 4. Patients who were able to give verbal information (Ericsson, Anders, Simon and Herbert, 1993). 5. Patients who were living in Nnewi and its environs (Ichi, Ojoto, Oba, Orifite, Amichi, Ukpor, Ozubulu, Nnobi, Nnokwa, Awka-etiti). This was for proximity and easy access for the patients to the study hospital (Ahmed and Samir et al, 2008). 6. Patients who could walk without the assistance of a walking aid. 7. Patients with at least grade 2 tibio-femoral OA on the kellegren/Lawrence grading scale Excluded from this study were patients: (Nevitt et al, 2006). 1. With knee injuries six months prior to the research 2. With total or partial endo-prosthesis or osteotomy of the knee joint 3. Who had Arthroscopy of knee joint 4. Who received corticosteroids or chondro-protective substance intra-articularly over the period of four weeks prior to the research 5. Who were currently participating in another clinical trial/study 6. Unwilling to sign informed consent 7. Unlikely to reside in the clinic area during period of study Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 65 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
No 30/06/2021 Nnamdi Azikiwe University Teaching Hospital ethical Committee
Ethics Committee Address
Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi Nnewi 1234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum cartilage oligomeric matrix protein and Hyaluronic Acid Two weekly
Secondary Outcome WOMAC INDICES Two weekly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Owerri Road Nnewi Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self. Dr Ebere Ihegihu Department of Medical Rehabilitation, NNAMDI AZIKIWE University Nnewi 1234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ebere Ihegihu Nnamdi Azikiwe University Nnewi Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Chima Ihegihu Department of Surgery, Nnamdi Azikiwe University Nnewi Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ebere Ihegihu yn.ihegihu@unizik.edu.ng +2349094296868 Nnamdi Azikiwe University. Owerri Road
City Postal code Country Position/Affiliation
Nnewi Nigeria Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Chima Ihegihu chimaihegihu@gmail.com +2348037125588 Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Nnewi Nigeria Reader
Role Name Email Phone Street address
Public Enquiries Prosper Okonkwo up.okonkwo@unizik.edu.ng +2348033611851 Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Nnewi Nigeria Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Not available now because I have not concluded study Informed Consent Form Not available now because I have not concluded study Not available because I have not concluded study
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information