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.: PACTR202105787963953 Date of Approval: 07/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Radial Shock Wave versus Instrument Assisted Soft Tissue Mobilization on Patellar Tendinopathy in Athletes
Official scientific title Effect of Radial Shock Wave versus Instrument Assisted Soft Tissue Mobilization on Patellar Tendinopathy in Athletes
Brief summary describing the background and objectives of the trial Patellar Tendinopathy is an overuse injury of the knee extensor mechanism due to repetitive mechanical stress from athletic activities requiring movements such as jumping, landing, acceleration, deceleration, and cutting. Micro-tearing of the knee extensor tendons can arise after constant repetition of these movements during a single exercise session or if there is insufficient rest between sessions. there is a wide range of people suffer from Patellar tendinopathy due to overuse of the patellar tendon The study will be done to answer the following question: Which is more effective in management of patellar tendinopathy, instrument assisted soft tissue mobilization or radial shock wave?
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 Rehabilitation
Anticipated trial start date 01/04/2020
Actual trial start date 01/04/2020
Anticipated date of last follow up 05/12/2020
Actual Last follow-up date 05/12/2020
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 60
Recruitment status Active, not 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
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
Control Group ice packs plus isometric exercises for knee extensors two sessions per week Six weeks Subjects received Ice packs for 15 minutes on the patellar tendon in addition to isometric exercises for knee extensors 20 Active-Treatment of Control Group
Experimental Group shockwave group One session per week Six weeks Subjects received one radial shock wave session per week for 5weeks in addition to ice packs and knee extensors isometric exercise. however, they received ice packs and knee extensors isometric exercise only in the sixth week. 20
Experimental Group Instrument assisted soft tissue mobilization group Two sessions per week Six weeks Subjects received Instrument assisted soft tissue mobilization in addition to ice packs and knee extensors isometric exercises. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1)Age range of 14-26 years. 2)Male and female 3)Subjects have anteriorly located knee pain, which is exacerbated by activity or sometimes by prolonged knee flexion 4) patients also experience pain at the beginning of specific activities or even throughout their sport activity. 5)Physical findings are straightforward in patellar tendinopathy. The most consistent finding is localized tenderness at the inferior patellar pole 1. Malignant tumor in the treatment area (not as underlying disease) 2.Fetus in the treatment area 3. Infection in the area to be treated 4. Over ischemic tissue in individuals with vascular disease 5. Patient has a coagulation disorder or if taking anti-coagulant medications 6. Patient has a prosthetic device in the area to be treated Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 14 Year(s) 26 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 22/03/2020 faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 ahmed el-zayat giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain pre and post treatment
Secondary Outcome functional activity pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy egyptian chinese university gesr elsuis cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Eslam mohammed mohammed Elkhalal 4 kolit elbanat building nasr city cairo 11865 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy cairo university 7 ahmed elzayat giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eslam Elkhalal eelkhalal@ecu.edu.eg 01092074925 eltouny
City Postal code Country Position/Affiliation
giza Egypt demonstrater at faculty of physical therapy egyptian chinese university
Role Name Email Phone Street address
Public Enquiries ragia mohamed ragiamohamed@yahoo.com 01222404923 7 ahmed elzayat
City Postal code Country Position/Affiliation
giza Egypt perfessor of basic science department faculty of physical therapy cairo university
Role Name Email Phone Street address
Scientific Enquiries yasser Aneis yasseraneis@pt.cu.edu 01011228823 7 ahmed elzayat
City Postal code Country Position/Affiliation
giza Egypt assistant perfessor of basic science department faculty of physical therapy cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual participant data collected during the trail, after de-identification Clinical Study Report,Study Protocol immediately following publication. no end date . anyone who wishes to access the date. for any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
URL will be added later 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