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.: PACTR202111486684050 Date of Approval: 16/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Global Postural Exercise Versus Muscle Energy Technique
Official scientific title Global Postural Exercise Program Versus Muscle Energy Technique on Management of Temporomandibular joint Disorders
Brief summary describing the background and objectives of the trial lack of comparative studies between Global Postural Exercise Program Versus Muscle Energy Technique on Management of Temporomandibular joint Disorders
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 20/11/2021
Actual trial start date
Anticipated date of last follow up 05/02/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Global Postural Exercise Program 8 exercises will last for six weeks. Exercises will be performed twice weekly for six weeks and each session with a duration of 45 min. for six weeks 8 exercises will last for six weeks. Exercises will be performed twice weekly for six weeks and each session with a duration of 45 min. With the conventional modalities LASER, hot applications, and massage 20
Experimental Group Muscle Energy Technique 3 Times/ week for six weeks the duration of each contraction 10 sec repeated for 5 times for six weeks Muscle Energy Technique 3 Times/ week for six weeks the duration of each contraction 10 sec repeated for 5 times plus conventional modalities LASER, hot applications, massage. 20
Control Group conventional modalities six weeks LASER, hot applications, and massage 3 times per week for six weeks 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Patients' age ranges from 20 to 40years old. 2-Patients are from both genders. 3-Patients will be diagnosed with a temporomandibular joint disorder. 4-Pain in the region of TMJ with limitation in mouth opening. 5-Symptoms are about three months. 6-All patients are medically stable Degenerative TMJ arthritis. Inflammatory TMJ arthritis. Infective TMJ arthritis. History of TMJ dislocation. History of fracture of Jaw. Previous mandibular surgery. Recent jaw trauma. Ankylosis of TMJ. Hypermobility of TMJ. Malignant tumor of face and jaw. Neurological disease and pregnancy. Cognitively impaired patients. Patients with a history of epilepsy. Patients with cardiac pacemakers. Adult: 19 Year-44 Year 20 Year(s) 40 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 10/11/2020 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzyat street Cairo 11411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pressure pain threshold pre and post intervention
Secondary Outcome TMJ range of motion pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahmed Maher teaching hospital Ahmed Maher street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nagwa Sayed Abd elwahed Ahmed Maher Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Maher teaching hospital Ahmed Maher Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nagwa Sayed Abd elwahed drnagwa15@yahoo.com 01115586156 7 Ahmed elzyat street
City Postal code Country Position/Affiliation
Giza Egypt Physical therapist at Ahmed Maher Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Amal Hasan Mohamed aebrahim123@yahoo.com 01200861702 Naser city
City Postal code Country Position/Affiliation
Cairo Egypt Professor of physical therapy Basic science department
Role Name Email Phone Street address
Scientific Enquiries Rania Nagi Karkosha rania.nagy@pt.cu.edu.eg 01227244630 Port said
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of physical therapy Basic science department
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) Clinical Study Report,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