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.: PACTR202103548001169 Date of Approval: 16/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title MYOFASCIAL RELEASE ON PAIN AND FUNCTION POST TOTAL KNEE REPLACEMENT
Official scientific title Impacts of Soft tissue Release on Pain and Function Post Total Knee Replacement
Brief summary describing the background and objectives of the trial Total Knee Replacement (TKR) is one of the most successful orthopedic procedures. However, approximately 10 percent of patients complain of pain similar to or worse than initial pre-operative complaints. Myofascial release (MFR) restores optimal length, decreases tone & pain, and improves function, vascular and lymphatic circulation. Despite this theoretical basis, no study has evaluated effects of MFR on pain and function post TKR. Objective: To investigate effects of MFR on pain and function in patients post TKR.
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 30/03/2021
Actual trial start date
Anticipated date of last follow up 15/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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 Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Myofascial release and exercises 3 days per week for 4 weeks 4 weeks Myofascial release added between 10-40 min to the session duration depending on the number of TrPs targeted and exercises 25
Control Group Exercises group 3 days per week for 4 weeks 4 weeks intensive functional rehabilitation include warm-up, specific strengthening exercises, functional task-oriented exercises, endurance exercises, and cool-down 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Pain for at least one month after TKR not relieved by oral medications and/or conventional physical therapy techniques (excluding the first 2 weeks postoperative). • Age between 50-80 years. • Patients post TKR due to Osteoarthritis. • Cemented TKR. • Patients who undergone conventional cemented TKR through a medial parapatellar approach & a midline skin incision at least 1 month ago. • Persistent pain despite conventional physical therapy techniques and analgesic drugs. • Any other surgical procedure of the lower limbs in the previous 6 months. • Rheumatoid arthritis. • Initiation of opioid analgesia or corticosteroid or analgesic injection intervention for hip or knee pain within the previous 30 days (excluding the first 2 weeks postoperative). • Physical impairments unrelated to the hip or knee preventing safe participation in exercise and/or manual therapy, such as body weight greater than 120 kg and neurogenic disorder. • Orthopedic evaluation revealed instability and/or mechanical dysfunction of the arthroplasty. • Infection. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 75 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 10/02/2021 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzyat street bin srayat Giza . Egypt Giza 11411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain assessment by the Arabic Numeric Pain Rating Scale (ANPRS) before and after intervention
Secondary Outcome knee function by the Arabic Knee injury and Osteoarthritis Outcome Score (AKOOS) before and after intervention
Secondary Outcome A pressure algometer is a method of quantifying soft tissue tenderness before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of EL Sheikh Zayed Specialized Hospital 122 EL-Sheikh Zayed street 6 October Giza 11511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed serag eldein mahgoub 77 shalhoub street ain shams Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor physiotherapy outpatient clinic of EL Sheikh Zayed Specialized Hospital 122 EL-Sheikh Zayed street 6 October Giza 11511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Fayioum General Hospital 6 Fayioum street Fayioum Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mostafa drsergany_79@hotmail.com 00201140974442 77 shalhoub street ain shams
City Postal code Country Position/Affiliation
Cairo Egypt Associate Professor Department of Physical Therapy for Basic Sciences Faculty of Physical Therapy Cairo University and Heliopolis university Egypt
Role Name Email Phone Street address
Public Enquiries Samah Saad Zahran Zahransamah77@yahoo.com 00201001187729 30 Feisal street haram
City Postal code Country Position/Affiliation
Giza Egypt lecturer of physical Therapy department for musculoskeletal disorders and their Surgery Faculty of Physical Therapy Cairo University.
Role Name Email Phone Street address
Scientific Enquiries Enas Mohammed Atyia Enasmatyia892@gmail.com 00201001861781 91 Ellebbine street, haram
City Postal code Country Position/Affiliation
Giza Egypt Physical Therapist specialist at General Faiyoum Hospital
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 deidentification (text, tables, figures, and appendices) Statistical Analysis Plan,Study Protocol 12 months period time after publication Controlling access to data
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