This study has been designed to assess the effect of botulinium toxin A in compare to isotonic normal saline on relieving myofascial pain due to temporomandibular disorder. The inclusion criteria include being diagnosed with myofascial type of temporomandibular disorder and the pain score equal or more than 30 based on visual analogue scale. Exclusion criteria include history of allergic reaction to botulinium toxin A and history of neurologic pains and the pain score being less than 30 based on visual analogue scale. 34 patients who fulfill inclusion and exclusion criteria will enter the study and will be randomly divided into two groups of 17 named intervention and placebo. All patients will receive both botulinium toxin A and placebo in crossover method. Patients in intervention group will receive 150 units of botulinium toxin A (diluted in 1 cc normal saline) which will be injected in several points on massetter and temporalis muscles based on level of tenderness of said points and they will be followed 1 and 4 months after intervention, then at the fifth month after the first injection they will receive 1 cc of normal saline which will be injected in the same sites, then they are again followed at first and fourth months after placebo treatment. The patients in placebo group will receive the same treatment but in reverse order. The main outcome was pain which measured based on visual analogue scale. The secondary outcome is psychosocial status based on McGill and SCL-90R questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051527894N2
Registration date:2017-04-26, 1396/02/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-26, 1396/02/06
Registrant information
Name
Mahdis Masoudrad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 6692
Email address
masoudrad.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of botulinum toxin type A injection for reducing the pain in patients with myofascial pain
Public title
comparison of the effect of botulinium toxin A injection with placebo in reducing the pain of patients with myofacial pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: minimum patient's age of 18 years; the disease being diagnosed as myofascial type of temporomandibular disorder; the pain score equal or more than 30 based on visual analogue scale.
Exclusion criteria: presence of connective tissue inflammatory diseases such as rheumatoid arthritis; temporomandibular disorder other than myofascial type; neuropathic pain or neurologic disorders; history of allergic reaction to botulinium toxin A; pregnancy;
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blv.
City
Ahvaz
Postal code
6193673166
Approval date
2016-03-15, 1394/12/25
Ethics committee reference number
IR.AJUMS.REC.1394.717
Health conditions studied
1
Description of health condition studied
temporomandibular disorder
ICD-10 code
K07.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
patient's pain
Timepoint
before intervention, one month after intervention, 4 months after intervention
Method of measurement
Measurement based on visual analogue scale
Secondary outcomes
1
Description
Patient's Psychosocial status
Timepoint
Before intervention, 1 month after, 4 months after
Method of measurement
MCGill and SCL-90R questionnaires
Intervention groups
1
Description
Intervention: Patients in intervention group will receive 150 units of botulinium toxin A (diluted in 1 cc normal saline) which will be injected in several points on masseter and temporalis muscles and they will be followed up at the first and fourth months after intervention, then at the fifth month after intervention they receive 1 cc normal saline which will be injected in the same sites, then they are again followed up at the first and fourth months after placebo treatment.
Category
Treatment - Drugs
2
Description
Control: The patients in placebo group firstly will receive 1 cc of normal saline which will be injected in several points on masseter and temporalis muscles, then they are followed up at the first and fourth months after placebo treatment then at the fifth month after receiving normal saline, they will receive 150 units of botulinium toxin A (diluted in 1 cc of normal saline) at the same sites and again are followed up at the first and fourth months after injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Maxillofacial Operating Room of Imam Khomeini Hospital
Full name of responsible person
Mahdis Masoudrad
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Behzad Sharif Makhmalzadeh
Street address
Golestan Boulevared
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahdis Masoudrad
Position
Resident of oral and maxillofacial surgery
Other areas of specialty/work
Street address
Maxillofacial operating room, Imam Khomeini Hospital, Azadegan Boulevard, Research Deputy of Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 3221 6504
Fax
Email
mahdis.mr@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahdis Masoudrad
Position
Resident of oral and maxillofacial surgery
Other areas of specialty/work
Street address
Azadegan Avn.
City
Ahvaz
Postal code
Phone
+98 61 3221 6504
Fax
Email
mahdis.mr@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahdis Masoudrad
Position
Resident of oral and maxillofacial surgery
Other areas of specialty/work
Street address
Maxillofacial operating room, Imam Khomeini Hospital, Azadegan Boulevard, Research Deputy of Imam Khomeini Hospital
City
Ahvaz
Postal code
6193673166
Phone
+98 61 3221 6504
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)