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.: PACTR201806003365317 Date of Approval: 03/05/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title effects of ultrasound, laser and exercises on temporomandibular joint pain and trismus following head and neck cancer
Official scientific title A comparative study on the effects of ultrasound, laser and exercises on temporomandibular joint pain and trismus following head and neck cancer
Brief summary describing the background and objectives of the trial Head and neck malignancies including tumors of the nose, oral cavity, pharynx, and larynx denote the sixth type of cancer worldwide. Cancer-related trismus takes place as a result of the tumor or due to its treatment. This randomized controlled study aimed to compare the effects of low intensity ultrasound (LIUS) plus traditional exercise therapy (TET), low level laser therapy (LLLT) and TET on temporomandibular joint (TMJ) pain and trismus following head and neck cancer (HNC).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Ear, Nose and Throat,Oral Health,Trismus, Pain, head and neck cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/03/2016
Actual trial start date 15/04/2016
Anticipated date of last follow up 15/02/2017
Actual Last follow-up date 20/05/2017
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
P.T . REC/012/001868 Hany Mohamed Ibrahim Elgohary
P.T . REC/012/001868 Hany Mohamed Ibrahim Elgohary
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 Concealed envelope randomization was used and the participant was then offered the allocated treatment sealed opaque envelops Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Concealed envelope randomization was used and the participant was then offered the allocated treatment sealed opaque envelops Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Laser 4.3 j/cm2 6 min LLLT was conducted by laser equipment (Electro Medical supplies manufactured by Greenham Ltd. Wantage, Oxford shire, England). After preparation of the patient, protective goggles were provided to both patient and therapist to protect eyes, the laser was given as (infrared laser), wavelength (950 nm), output power 15 mw, pulsed 80% , at a dose of 4.3 j/cm2, Max energy density (7.6 j/cm2 ) for 6 mi 20
Experimental Group ultrasound 1 MHz, pulsed mode 60% and a dose of 1.0 w/cm2 5 min LIUS therapy was conducted by a therapeutic ultrasound machine (Sonicator 740, output of AC: 230 volt, 50/60 Hz, Max power consumption: 73W and frequency: 1 MH/3; manufactured in UK). LIUS therapy was applied to the patient while sitting in a comfortable position at frequency of 1 MHz, pulsed mode 60% and a dose of 1.0 w/cm2 for 5 min. over the masseter muscle extra orally, 5 times a week for 3 co 20
Control Group exercises 10 seconds each 3 times daily The traditional exercise therapy was given to the three groups of the study as a form of passive and active range of motion, stretching exercises, and resistive mouth exercises, each type of exercise was performed for 6 seconds duration and repeated for 10 times. The exercises were performed twice daily for 5 times a week for 4 consecutive weeks 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
They were recruited in the study if their clinical assessment revealed that they suffered from trismus and pain following HNC. The criteria of exclusion included patients who had any medical conditions or health problems that may affect the results of the study as implants, Pregnancy, sensitivity to phototherapy, or any neurological condition impacting the facial nerve as Bell¿s palsy 50 Year(s) 70 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 15/01/2017 Faculty of Physical Therapy; Cairo University
Ethics Committee Address
Street address City Postal code Country
Ahmed elzayyat street, Dokki Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measurement of maximum mouth opening by using VCS at baseline and after 3 weeks
Primary Outcome Measurement of pain intensity using VAS at baseline and after 3 weeks
Secondary Outcome (UW-QOL) questionnaire The UW-QOL questionnaire of version 4 composed of 12 sole question fields; (pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood, and anxiety). These requiring between 3 and 6 answer options that are scored consistently from 0 (worst) to 100 (best) according to the grading of response
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Cancer Institute in Cairo kase elaini street Cairo 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
infrastructure support Ahmed Elzayyat street Cairo 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Ahmed Elzayyat street Cairo 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hadaya Mosaad Ahmed Elzayyat street Cairo 11432 Egypt
Ashraf Saleh Ahmed Elzayyat street Cairo 11432 Egypt
Elsadat Saad Soliman Ahmed Elzayyat street Cairo 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Elgohary gohary75pt@hotmail.com 00201001123384 Ahmed Elzayyat street- Dokki, Cairo
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Hany Elgohary gohary75pt@hotmail.com 00201001123384 Ahmed Elzayyat street- Dokki, Cairo
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Hadaya Mosaad Eladl hd_mos@yahoo.com 01001123384 Ahmed Elzayyat street
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Ashraf hassan Saleh ashsaleh1976@hotmail.com 01001123384 Ahmed Elzayyat street
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Elsadat Soliman sadatsaad@yahoo.com 00201129893636 Ahmed Elzayat street
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Lecturer
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