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.: PACTR201909524416162 Date of Approval: 16/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Investigating the efficacy of some selected Physiotherapy Modalities in the Management of Achilles Tendinopathy and Associated Genetic Variance among Nigerian Footballers.
Official scientific title Investigating the efficacy of some selected Physiotherapy Modalities in the Management of Achilles Tendinopathy and Associated Genetic Variance among Nigerian Footballers.
Brief summary describing the background and objectives of the trial The Achilles tendon (AT) whose major function is to transmit the force produced by the calf muscles to the heel bone is the largest and strongest tendon and also the most frequently ruptured in the human body. Exposure of the tendon to excessive mechanical loadings during vigorous exercises such as running and jumping may easily result rupture and tendinopathy and cause up to 5% of professional athletes to end their careers. Physiotherapy is generally accepted as the first line approach for managing Achilles tendinopathy and the role of genetic variation in tendinopathy and its prognosis is typically less studied. The purpose of this study is to investigate the efficacy of therapeutic ultrasound, eccentric exercises and intrasound therapy in the management of Achilles tendinopathy and possible genetic variance associated with Achilles tendinopathy among Nigerian Footballers.
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 24/06/2019
Actual trial start date 27/08/2019
Anticipated date of last follow up 02/10/2019
Actual Last follow-up date 28/02/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 175
Recruitment status Completed
Publication URL Unavailable
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intrasound Therapy Intrasonic wave will be transmitted into the Achilles tendon for ten (10) minutes using the moderate intensity mode. This will be administered three (3) times a week Eight (8) weeks Participants will be asked to lie prone on a plinth with the ankle and the feet hanging over the edge of the plinth which is the zero angle position for the ankle joint. The intrasound therapy device will be plugged in and set at the most comfortable intensity and frequency for the participants. The intrasound probe will be moved over the affected part of the Achilles tendon in circular motion over the affected region of the Achilles tendon for (ten) 10 minutes with a water soluble coupling medium (or K-Y gel) to transmit the sound wave down into the achilles tendon. The Participants will report the feeling they have during the procedure and also monitored for any adverse reaction to the intrasound therapy treatment. 10
Experimental Group Therapeutic Ultrasound Ultrasonic waves will be transmitted to the Achilles tendon for ten (10) minutes, using the continuous mode and 5w/cm2 intensity. This is administered thrice a week. Eight (8) weeks Subjects will be asked to lie prone on a plinth with the ankle and feet hanging over the edge of the plinth which is a zero angle position for the ankle joint. The ultrasound machine will be plugged in, set at the most comfortable intensity and pulsed mode frequency for the subjects. The ultrasound probe will be moved over the affected part of the Achilles tendon in circular motion over the affected region of the Achilles tendon for 10 minutes with a water soluble coupling medium (ultrasound gel) to transmit the sound wave down into the Achilles tendon. The subjects will report the feeling they have during the procedure and also monitored for any adverse reaction to the ultrasound therapy treatment. 10
Experimental Group Eccentric Exercises Participants in this group will receive low to moderate intensity eccentric strengthening and stretching exercises of the triceps surae and free active exercises of the ankle three times a week. And it includes 3 sets of 15 slow repetitions Eight (8) weeks The gastrocnemius muscle will be eccentrically loaded with both knees straight, to maximize the activation of the soleus muscle, also with the knee bent. Each of the exercises will include fifteen (15) repetitions done in three sets. 10
Control Group Asymptomatic Matched Controls Negative to all clinical tests and Ultrasonograph of the Achilles tendon. No Intervention No intervention The participants in this group are matched controls. They were included in the study in order to obtain the normative data of the study population. 10 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Participants who have played football actively in the last 6 months. 2. Participants with diagnosis of Achilles tendinopathy with clinical tests and/ ultrasonography. 3. Participants currently engaged in full training and match responsibilities at the time of this study. 1. 1. Participants who have undergone surgical repair of the Achilles tendon. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 25/07/2019 College of Medicine University of Lagos Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
2nd floor, Biomedical Engineering Block, College of Medicine, University of Lagos Lagos 100254 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain of the Achilles Tendon Pre- Intervention and Post Intervention
Primary Outcome Severity of Achilles Tendinopathy Pre- Intervention and Post Intervention
Primary Outcome Ankle Function Pre- Intervention and Post Intervention
Primary Outcome Quality of Life Pre- Intervention and Post Intervention
Primary Outcome Genetic Variance associated with Achilles Tendinopathy Genetic Variance will be taken Pre- Intervention only
Secondary Outcome Tendon Structure Pre- Intervention and Post Intervention
Primary Outcome Ankle Range of Motion for Dorsiflexion and Planterflexion Pre- Intervention and Post Intervention
Secondary Outcome Prevalence of Achilles Tendinopathy Pre- Intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sport Centre University of Lagos Akoka Road, Yaba Lagos Lagos 100213 Nigeria
Lagos University Teaching Hospital Idi-araba, Ishaga Road Lagos Lagos 100254 Nigeria
National Stadium Surulere Avenue Street Lagos Lagos 101282 Nigeria
Itedo Playing Ground The dome, itedo, Lekki Lagos 105102 Nigeria
Yaba College of Technology Sport Centre Herbert Markaulay Road, Yaba Lagos 100001 Nigeria
Bishop Age Playing field Mushin Local Government Lagos 100253 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Owoeye Itunu Opeyemi Number 81, Apapa Road, Ebute Meta Lagos 101211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Owoeye Itunu Opeyemi Number 81, Apapa Road, Ebute-Meta West Lagos Lagos 101211 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr A.I Aiyegbusi Department of Physiotherapy, College of Medicine, University of Lagos Idi-araba, Ishaga Road Lagos 100254 Nigeria
Prodessor A. Akinloye Department of Clinical Chemistry and Molecular Diagnosis, College of Medicine, University of Lagos, Idi-araba, Ishaga Road Lagos 100254 Nigeria
Dr F.A Agboola Department of Radiology, College of Medicine, University of Lagos Idi-Araba. Ishaga Road Lagos 100254 Nigeria
Senlaja Abigail Motunrayo Department of Medical Laboratory Sciences, College of Medicine University of Lagos Lagos 100254 Nigeria
Umeadi Chidinma Department of Medical Laboratory Science, College of Medicine, University of Lagos Lagos 100254 Nigeria
Sodeke Seun Department of Genetics, University of Lagos Lagos 100213 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Itunu Owoeye owoeye.itunu012@gmail.com +2348154663827 Number 81, Apapa Road Ebute Meta West Lagos
City Postal code Country Position/Affiliation
Lagos 101211 Nigeria Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Ayoola Aiyegbusi aiaiyegbusi@unilag.edu.ng +2348023212513 Idi- araba, Ishaga Road
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Scientific Enquiries
Role Name Email Phone Street address
Public Enquiries Ashiyat Akodu akoduashiyat@gmail.com +2348034269053 Idi- araba, Ishaga Road
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Public Enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Excel spread sheet containing, participant's football league/club, age, gender, ethnicity, state of origin, parity, height, weight, blood pressure, random blood sugar, genotype and blood group. Also contained in the form are spaces to fill in the pre and post intervention outcomes Informed Consent Form,Study Protocol 1- 2 year post completion of study Open access, descriptive statistics of mean median and mode, frequencies and percentages, ANOVA, and Fisher's test. Process of requesting data and criteria for reviewing request of will be directly though the primary and secondary investigators.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Unavailable Yes 05/04/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 05/04/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information