Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Maximum Mouth Opening (MMO) after Orthognathic Surgery
Design
Two arm parallel group randomized clinical trial on 82 patients
Settings and conduct
This study takes place in Imam Hossein hospital .
Patients are divided into intervention and control groups by the use of accidental blocks classified by age and sex .
The intervention group goes is underwent Transcutaneous Electro Nerve Simulation (TENS) physiotherapy 3 sessions a week for a month starting the day after surgery.
other post operative protocols are the same in both intervention and control groups.
Maximum Mouth Opening (MMO) will be measured once before surgery as a baseline and then 1 and 6 month after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Skeletal Class III patients who are candidates for Lefort I maxillary advancement and Bilateral Sagittal Split Osteotomy mandibular set back with Dalpont method
exclusion criteria :
Pathologic lesions around surgical areas
History of limitation in jaw movements
Drug use due to psychological problems
History of jaw fractures
Previous jaw surgery
If maxillary advancement or mandibular setback is more than 6 millimeters
Surgeries longer than 6 hours
Bad split and on-the-job accidents
Simultaneous genioplasty performing
Patients who need other maxillofacial surgery after orthosurgy
Patients with cardiac pacemaker
Epilepsy patients
Patients with a history of Cerebro-Vascular Accident
Intervention groups
The intervention group takes TENS physiotherapy sessions.
This patients will have 12 physiotherapy sessions ; 3 times a week for one month which starts the day after surgery.
other post operative protocols are the same in both intervention and control group.
Main outcome variables
Maximum Mouth Opening (MMO) after Orthognathic Surgery following "TENS physiotherapy"
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211205053279N2
Registration date:2022-12-07, 1401/09/16
Registration timing:registered_while_recruiting
Last update:2022-12-07, 1401/09/16
Update count:0
Registration date
2022-12-07, 1401/09/16
Registrant information
Name
Mostafa Alam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4464 8012
Email address
mostafa_alam@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-03, 1400/12/12
Expected recruitment end date
2023-03-03, 1401/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Maximum Mouth Opening (MMO) after Orthognathic Surgery
Public title
Effect of Physiotherapy on Maximum Mouth Opening after Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Skeletal class III patients
candidates for lefort I osteotomy maxillary advancement and BSSO(Bilateral Sagittal Split Osteaotomy) mandibular setback with Dalpont method
Exclusion criteria:
Pathologic lesions around surgical areas
History of jaw movements limitation
Taking medicine due to mental problems
History of jaw fracture
Previous jaw surgery
If maxillary advancement or mandibular setback is more than 6 millimeters
Surgeries longer than 6 hours
Bad split and work related injuries
Simultaneous Genioplasty
Patients who need further maxillofacial surgery after Orthognathic surgery
Patients who have heart pacemaker
Patients with epilepsy
Patients with CVA history
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized blocks method classified by age and sex
The randomized block design takes account of known factors that affect outcome but are not of primary interest. The two steps in randomized block design are:
1. Collect together homogeneous experimental units (e.g.sex) into a block
2.Assign treatments at random to the experimental units within a block.
Homogeneous patients, for example 20-25 years old men are placed in a block of four.
For each block we will have 6 modes:(i:intervention c:control)
I I C C
I C I C
I C C I
C C I I
C I C I
C I I C
By throwing a dice for each block, it is determined how patients enter the intervention and control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Dental Sciences Shahid Beheshti University of Medical Sciences
Street address
10th Unit , No 6 , 36th Street , Usefabad Ave
City
Tehran
Province
Tehran
Postal code
6557 199143
Approval date
2022-02-12, 1400/11/23
Ethics committee reference number
IR.SBMU.DRC.REC.1400.174
Health conditions studied
1
Description of health condition studied
Maximum Mouth Opening (MMO) after Orthognathic Surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maximum mouth opening
Timepoint
Before surgery , 1 month after surgery ,6 months after surgery
Method of measurement
Digital caliper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: TENS physiotherapy.3 sessions a week for a month starting the day after surgery,12 sessions in total. TENS, or transcutaneous electrical nerve stimulation, is a category of electrical modalities that is used in physiotherapy to treat pain, inflammation, muscle spasms, weakness, and other neuromuscular disorders. The electrodes of the device are placed on the healthy skin in the surgical area bilaterally, high and low frequency stimulations start in standard parameters in terms of frequency, duration and pulsed width. Traditional TENS requirements: Frequency of 150Hz, pulse width of 20 microseconds, pulse intensity starts from 10-30 mA and will be adjusted exclusively for each individual to the maximum tolerance threshold (but to the extent that the patient is comfortable). The pulses are Quadratic Biphasic Symmetrical and the modulation of up to 50% of the frequency variation and time of each session will be 45 minutes. Maximum Mouth Opening (The distance between the edges of the upper and lower incisors) will be measured by a digital caliper once before surgery as a baseline and then 1 and 6 months after surgery, recording and evaluation will be performed.
Category
Rehabilitation
2
Description
Control group: no interventions. Maximum Mouth Opening (The distance between the edges of the upper and lower incisors) will be measured by a digital caliper once before surgery as a baseline and then 1 and 6months after surgery. Recording and evaluation will be performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Mostafa Alam
Street address
Madani Ave.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
info@ehmc.ir
Web page address
https://www.ehmc.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Tehran, Velenjak, Daneshjoo Blvd., Arabi St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Alam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Velenjak St. , Shahid Chamran Highway,
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
mostafa_alam1@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Alam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Velenjak St. , Shahid Chamran Highway,
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
mostafa_alam1@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Alam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Velenjak St. , Shahid Chamran Highway,
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
mostafa_alam1@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available