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.: PACTR202407817168154 Date of Approval: 17/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Short term efficacy of shockwave therapy on pain and function of patients with severe knee
Official scientific title Short term efficacy of shockwave therapy on pain and function of patients with severe knee
Brief summary describing the background and objectives of the trial Knee osteoarthritis (KOA) is a chronic joint disorder affecting the elderly, causing knee pain, physical declines, and reduced daily activities. Arthroplasty is a cost-effective treatment for moderate or severe KOA. Researchers have investigated the use of Electroshockwave Therapy (ESWT) in treating KOA. ESWT enhances tissue repair, promotes local microcirculation, and stimulates cells to release anti-inflammatory cytokines. It also disrupts fibrotic tissue, disintegrates calcifications, and increases synovial fluid, alleviating pain and inflammation. This study aims to measure the short-term efficacy of ESWT on pain and function in patients with severe KOA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) no
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 05/08/2024
Actual trial start date
Anticipated date of last follow up 11/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Not yet 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
Experimental Group Group 1 6 weeks receive 12 sessions of shockwave therapy and traditional physical therapy 30
Experimental Group Group 2 6 weeks receive traditional physical therapy 30
Control Group Group 3 6 weeks receive physician follow up 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) 90 patients with severe knee OA. 2) The age of patients will range from 60-85 years old. 3) Patients had already enrolled for total knee replacement surgery. 1) mild and moderate KOA, 2) history of surgery in the lower limbs, spine, or pelvis Aged: 65+ Year(s) 65 Year(s) 85 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 05/03/2024 research ethical committee faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS (Visual Analogue Scale) for pain, WOMAC (The Western Ontario and McMaster Universities Arthritis Index) for functional assesment after 6 weeks of treatment
Secondary Outcome TUG (time up and go test) for fuctional assesment after 6 weeks of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical thrapy cairo university outpatient clinic El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi Al Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self 4 sherif st giza giza 12551 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor joseph wageeh 4 sherif st giza 12551 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ehab ali eabdallah@horus.edu.eg +201223674916 Quesna
City Postal code Country Position/Affiliation
Monufia Egypt lecturer of orthopedic faculty of physical therapy horus university
Role Name Email Phone Street address
Scientific Enquiries joseph wageeh saweres josephwageeh83@gmail.com +201226568632 4 sherif st
City Postal code Country Position/Affiliation
giza Egypt lecturer of basic science faculty of phyical therapy suez canal university
Role Name Email Phone Street address
Public Enquiries moustafa mahmoud mmahmoud345@yahoo.com +235678024 saida zainab
City Postal code Country Position/Affiliation
cairo Egypt head of ethical department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share the deidentified IPD that makes our summarised results of the trial after finishing the study by uploading the raw data. Informed Consent Form,Statistical Analysis Plan One year the criteria will be accessed by the puplication of the trial in international journal
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