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.: PACTR201511001330380 Date of Approval: 31/10/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title THE EFFECT OF LOW LEVEL LASER THERAPY ON PAIN, FUNCTION AND QUALITY OF LIFE IN PATIENTS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION
Official scientific title THE EFFECT OF LOW LEVEL LASER THERAPY ON PAIN, FUNCTION AND QUALITY OF LIFE IN PATIENTS WITH TEMPOROMANDIBULAR JOINT DYSFUNCTION
Brief summary describing the background and objectives of the trial Temporomandibular dysfunction (TMD) is one of the problems that affect the quality of life style through presence of pain around the joint radiated in the face, neck, or shoulders muscles and decreasing in function of TMJ that lead to difficult in mastication, swallowing and even in talking. Other symptoms such as headaches, earaches, dizziness, and hearing problems may sometimes be associated with TMD. The initial management of TMD includes supportive patient education, pharmacologic pain control, and physical therapy. Low-level laser therapy (LLLT) seems to be one of the approaches used with TMD¿s treatment philosophy, because it represents a noninvasive, reversible therapy without any known side effects. LILT makes use of the electromagnetic radiation of a single wavelength, usually in the red or infrared regions. LLLT provides treatment for several pathologies, including impaired wound healing, pain conditions, and inflammatory situations. Delimitation This study will be delimited to the following 1-The sample size will be determined according to power analysis. 2-Patient from both gender 3-Age ranging from 20 ¿ 60. Limitation This study will be limited by the following 1-Infrequent attendance of patient in the treatment session or during the evaluation procedure. 2-Personal and individual differences between subjects.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Temporomandibular dysfunction
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2015
Actual trial start date 03/01/2016
Anticipated date of last follow up 10/05/2016
Actual Last follow-up date 01/06/2016
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants) 54
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
Randomised by random allocation software Numbered containers Masking/blinding used
Randomised by random allocation software Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TMJ myofascial pain syndrome group 3 times aweek 4 weeks a) conventional physical therapy treatment. b) LLLT. 14
Control Group TMJ myofascial pain syndrome control group 3 times aweek 4 weeks Conventional physical therapy treatment. 14 Active-Treatment of Control Group
Experimental Group TMJ osteoathritis group 3 times aweek 4 weeks a) conventional physical therapy treatment. b) LLLT. 14
Control Group TMJ osteoathritis control group 3 times aweek 4 weeks conventional physical therapy treatment. 14 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-All participants diagnoses with myofascial pain or osteoarthritis of TMJ. 1-Presence of systematic musculo-articular pathologies. 2- Pregnant women. 3- History of facial trauma. 4- Facial palsy. 5- Fractures of the facial bones. 20 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
No 10/11/2015 physical therapy committee
Ethics Committee Address
Street address City Postal code Country
eldoky cairo 8763 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain algometry. before and after treatment program
Primary Outcome Functional questionnaire (Jaw functional Questionnaire). before and after treatment program
Primary Outcome Quality of life questionnaire (McGIL Quality of life Questionnaire). before and after treatment program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
october 6 university elhai elsabe october city 5234 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal funding elhai elsabe october city 5234 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor walled saber eltawheed we elnoor shoubra 1234 Egypt University
COLLABORATORS
Name Street address City Postal code Country
emad eldin mohamed elhai elsabe october city 5234 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator rehab El-Saeed rehablovely@gmail.com 01001529774 elhai elsabe
City Postal code Country Position/Affiliation
october 5 city 1234 Egypt physical therapist
Role Name Email Phone Street address
Public Enquiries rehab El-Saeed rehablovely@gmail.com 01001529774 elhai elsabe
City Postal code Country Position/Affiliation
october 5 city 1234 Egypt physical therapist
Role Name Email Phone Street address
Scientific Enquiries rehab El-Saeed rehablovely@gmail.com 01001529774 elhai elsabe
City Postal code Country Position/Affiliation
october 5 city 1234 Egypt physical therapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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