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.: PACTR201707002386207 Date of Approval: 27/06/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Graston Technique versus Muscle Energy Technique on Hamstring Flexibility in Knee Osteoarthritis Patients
Official scientific title Graston Technique versus Muscle Energy Technique on Hamstring Flexibility in Knee Osteoarthritis Patients
Brief summary describing the background and objectives of the trial Osteoarthritis (OA) is one of the most prevalent articular disorders affecting humankind and a major cause of disability and socioeconomic burden. It can be defined as a chronic degenerative disorder that is characterized by multifactorial etiology, including acute and/or chronic insults from normal wear and tear, age, obesity, and joint injury. Functional disability is a typical characteristic in people with knee osteoarthritis. Over the years, numerous factors have been proposed as possible explanations for the level of functional disability in people with knee OA. Among these factors is reduced knee joint range of motion. One of the factors that compromise knee joint range of motion is hamstring tightness. Several studies have indicated that flexibility of the hamstrings is improved by stretching. Indeed, many stretching techniques are used in clinical practice, including ballistic stretching, static stretching, and muscle energy technique. Recently, Graston instrumented soft tissue mobilization has been reported to be effective in promoting the extensibility of the shortened hamstring. The purpose of this study is to compare the effect of Graston Technique and Muscle Energy Technique on hamstring flexibility in in knee osteoarthritis patients.Subjects with moderate unilateral OA of the knee on the dominant side (Kellgren & Lawrence grade 3' moderate') from both sexes will be selected by simple random method aged between 38 and 50 years, their BMI below 30 kg/m2. They will be randomly divided into 3 equal groups I, II and III. We will assess knee ROM by Electrogoniometer, hamstring flexibility by Sit and Reach Flexibility Test, stability index by Biodex Balance System and functional performance by WOMAC scale.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) OA GT MET WOMAC
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Knee osteoarthritis,Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2017
Actual trial start date
Anticipated date of last follow up 01/06/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling. Allocation was determined by the holder of the sequence who is situated off site. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Muscle energy technique Twelve sessions Four weeks The participant provides a moderate knee flexion isometric contraction (approximately 50% of maximal contraction)for 7¿10 s. This is followed by 2¿3 s of relaxation, and then the leg is passively stretched by the researcher to the palpated barrier and/or tolerance to stretch and held for 30 seconds. 15
Control Group Traditional treatment Twelve sessions Four weeks Strengthening exercises of the quadriceps muscle and stretching exercises of the hamstrings muscle and hot packs. 15 Active-Treatment of Control Group
Experimental Group Graston technique Twelve sessions Four weeks The subject lies prone and bends the knee joint to around 30° to 60°. After applying massage cream on the hamstring muscle, the Graston instrument is rubbed on each subject 30 times for 60 seconds from the gluteal line to the popliteal fossa. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Moderate knee OA (Grade 3 according to Kellgren & Lawrence) from both sexes. Age between 38 to 50 years. BMI below 30 kg/m2. Any of the criteria of the American college of rheumatology which include: 1.Knee pain and crepitus with active motion and morning stiffness less than 30 min and age more than 38 years. 2.Knee pain and crepitus with active motion and morning stiffness more than 30 min and bony enlargement. 3.Knee pain and no crepitus and bony enlargement. The patients have any systemic illness, dermatological problems, skin allergy, local ischemic problems, atrophic or scarred skin or bleeding. The patients have received any physiotherapy program or intra-articular injection or acupuncture treatment in the preceding year. The patients have symptoms and signs of acute knee synovitis, psychiatric disorders, having hearing aids or pacemaker, inability to understand instructions or give consent. The patients are taking any medications known to affect pain level. The patients have any neurological disorders or have active neoplasm or any hemorrhagic condition affecting the lower limbs. 38 Year(s) 50 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 11/09/2017 Faculty of Physical Therapy Research Ethics
Ethics Committee Address
Street address City Postal code Country
Ahmad al-Zayyat St. Giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knee extension Before treatment After completion of treatment sessions
Primary Outcome Hamstring flexibility Before treatment After completion of treatment sessions
Primary Outcome Functional performance Before treatment After completion of treatment sessions
Secondary Outcome Stability index Before treatment After completion of treatment sessions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of Faculty of Physical Therapy Ahmad al-Zayyat St. Giza Egypt
Outpatient clinic of Manshiat Al-Bakry hospital Gesr al-Suez St. Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Ahmad al-Zayyat St. Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amal Hassan Muhammad Ahmad al-Zayyat St. Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amal Ibrahim aebrahim123@hotmail.com +20120086577697 Ahmad al-Zayyat St.
City Postal code Country Position/Affiliation
Giza Egypt
Role Name Email Phone Street address
Public Enquiries Amal Ibrahim aebrahim123@hotmail.com +20120086577697 Ahmad al-Zayyat St.
City Postal code Country Position/Affiliation
Giza Egypt
Role Name Email Phone Street address
Scientific Enquiries Amal Ibrahim aebrahim123@hotmail.com +20120086577697 Ahmad al-Zayyat St.
City Postal code Country Position/Affiliation
Giza Egypt
REPORTING
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