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.: PACTR202007859291241 Date of Approval: 30/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mechanical Traction from Different Knee Joint Positions in Patients with Knee Osteoarthritis
Official scientific title The most effective position for mechanical traction in patients with knee OA: Randomized controlled trial
Brief summary describing the background and objectives of the trial Traction is a physical therapy modality used commonly in spinal pain (Chiu et al., 2011). However, experience in traction treatment for knee osteoarthritis is limited (Özdolap et al., 2006; Birtane et al., 2001), and the most effective position of traction application for knee osteoarthritis is unclear. so this study will be conducted to investigate the most effective position for mechanical traction in patients with knee OA
Type of trial RCT
Acronym (If the trial has an acronym then please provide) OA
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 25/07/2020
Actual trial start date 25/07/2020
Anticipated date of last follow up 25/01/2021
Actual Last follow-up date 25/01/2021
Anticipated target sample size (number of participants) 112
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Exercise therapy TENS Ultrasound 12 sessions for 1 month Patients in a control group will be received standard physiotherapy treatment include: 1-Exercise therapy which will be a supervised program, included active range of motion, muscle strengthening and muscle stretching exercises and consist of: - Hamstring Stretching - Gastrocnemius Stretching - Static (Isometric) Quad Sets Exercise - Straight Leg Raising (SLR) Exercise - Flexion to Extension Exercise - Terminal Knee Extension Exercise - Hip Abduction Exercise 2- Transcutaneous electrical nerve stimulation: TENS has beneficial effects on relieving pain and improving physical function which are applied directly to the skin and surrounding the knee 3- Ultrasound: ultrasound reduces pain and improves the aerobic condition 28 Active-Treatment of Control Group
Experimental Group Mechanical traction and Exercise therapy . TENS .Ultrasound 12 sessions for 1 month Patients will be received standard physiotherapy treatment and Continuous traction while knee extended with a weight of 15 kg will be used, for 15 minutes, 28
Experimental Group Mechanical traction and Exercise therapy . TENS .Ultrasound 12 sessions for 1 month Patients will be received standard physiotherapy treatment and Continuous traction while knee flexed 20 to 30 degree with a weight of 15 kg will be used, for 15 minutes 28
Experimental Group Mechanical traction and Exercise therapy . TENS .Ultrasound 12 sessions for 1 month Patients will be received standard physiotherapy treatment and Continuous traction while knee and hip in 90 degree with a weight of 15 kg will be used, for 15 minutes, 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- age will be between 45 to 60 years, from both genders - unilateral (grade 2 and 3) knee OA according to the Kellgren–Lawrence radiological rating scale - BMI less than 30 - Patients with any knee deformities (e.g. fixed flexion deformity, genu valgum) - inflammatory joint disease and joint infections - injections or physical therapy on the knee within the last three months, - use of steroid or non-steroidal anti-inflammatory drug within the last 15 days, - other causes of pain in the lower extremity (e.g. polyneuropathy, restless leg syndrome, fibromyal¬gia, hip pathologies, spinal root compressions, cen¬tral nervous system diseases), - mental status disorders, and poor medical condition - previous ligament or meniscal injuries - bone tumors Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 60 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 05/05/2019 Faulty of physical therapy ethics committee
Ethics Committee Address
Street address City Postal code Country
7th elzayat street Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The visual analogue scale(VAS): VAS is commonly used as the outcome measure for those with rheumatic diseases .It is usually presented as a 100-mm horizontal line on which the patient’s pain intensity is represented by a point between the extremes of “no pain at all” and “worst pain imaginable.” before and after completion of study
Primary Outcome Arabic version of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be used to assess functional level.It was developed to assess and quantify pain, joint stiffness and disability related to osteoarthritis of the knee and hip. The Index contains 24 questions, 5 related to pain, 2 to stiffness and 17 to physical function. before and after completion of study
Secondary Outcome Knee joint range of motion (ROM) will be measured using a smartphone application (the Knee Goniometer App (Ockendon(©))) (KGA) before and after completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Assiut Hospital Al-Ghoub Square Assiut Egypt
Assiut university hospital Al Fath, Assiut Governorate Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alaa Abdelraheem Mohammed El Weledya, Sea Street Assuit Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alaa Abdelraheem Mohammed El Weledya, Sea Street Assuit Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amal Hassan Mohamed Faulty of physical therapy. 7th elzayat street Giza Egypt
Nabil Mahmoud Ismail Faulty of physical therapy. 7th elzayat street Giza Egypt
Mohammed Qutb Hassan Faulty of Medicine.Al Fath, Assiut Governorate Assuit Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Abdelraheem Mohammed dralaa650@gmail.com 00201006896552 El Weledya, Sea Street
City Postal code Country Position/Affiliation
Assuit Egypt Doctor Of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries Amal Hassan Mohamed Info@pt.cu.edu.eg 00237617691 Faulty of physical therapy. 7th elzayat street
City Postal code Country Position/Affiliation
Giza Egypt professor of physical therapy
Role Name Email Phone Street address
Public Enquiries Nabil Mahmoud Ismail Nabil.mahmoud@cu.edu.eg 00201200133613 Faulty of physical therapy. 7th elzayat street
City Postal code Country Position/Affiliation
Giza Egypt lecturer of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the result of the trial 1-pain 2-functional 3-range of motion (ROM) to investigate the most effective position for mechanical traction in patients with knee OA Clinical Study Report,Statistical Analysis Plan,Study Protocol 6 months The criteria will be accessed by the publication of trials 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