Compare effectiveness of trans cutaneous electrical nerve stimulation(TENS) and low level laser therapy( LLLT) in temporomandibular joint disorder(TMD) patients who don't response to pharmacological therapy.
Design
Clinical trial with parallel group, single blind, Block randomized.
Settings and conduct
Patients referred to the Oral medicine Department of Shiraz Dental school, receive laser and TENS treatment by one person in block randomization method. The examiner who records the data, is blind.
Participants/Inclusion and exclusion criteria
"Inclusion criteria:Patients have pain in temporomandibular joint regions and muscles; with or without noise in joints ; with or without limitation in jaw movements"
"Exclusion criteria: patient with systemic disease and medicine usage"
Intervention groups
"Intervention group1:TENS. TENS (NEURDYN) is applied for 8 consecutive sessions for 2 weeks, 20 minutes on painful muscle."
"Intervention group 2: Laser. low-power laser (AZOR) is applied for 10 sessions, every other day, with a dose of 12 J / cm 2 on the muscle and joint."
Main outcome variables
Pain; Function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130521013406N4
Registration date:2019-04-10, 1398/01/21
Registration timing:retrospective
Last update:2019-04-10, 1398/01/21
Update count:0
Registration date
2019-04-10, 1398/01/21
Registrant information
Name
Fahimeh Rezazadeh
Name of organization / entity
Dental school of shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 1628 9917
Email address
rezazadehf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-01-06, 1397/10/16
Trial completion date
2019-02-20, 1397/12/01
Scientific title
Comparison between the effect of physiotherapy and Laser Therapy on the management of temporomandibular joint disorders
Public title
Comparison between the effect of physiotherapy and Laser on the treatment of temporomandibular joint disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients have pain in TMJ regions and muscles with or without noise in joints and with or without limitation in jaw movements
Exclusion criteria:
Missing of five or more posterior teeth ( except for third molars)
Systemic diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The method is Block randomization . Each block with 4 allocations, consisting 2 allocation for intervention and 2 for control group will be considered. Six possible sequence of treatment allocation in each block will be listed and each one will be written on a card. Each time a block will be selected and the sequence of treatment will be registered until the treatment allocations become completed for all 30 participants (8 blocks). The randomization was performed by a methodologist. Allocation concealment will be done by the main researcher. On each 30 cards a sequence will be written and sealed. Pockets will be put in a box. A pocket will be allocated for each participant based on order of enrollment.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the examiner is blind. In this way, the examiner or data collector, during pain and joint function examination, is not aware of the type of treatment that patients receive when assessing pain and function. But the patient and the main investigator who applies the treatment, are not blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Medical Science Building,Zand Street,Namazee Square,Shiraz
City
Shiraz
Province
Fars
Postal code
71345-54213
Approval date
2015-11-11, 1394/08/20
Ethics committee reference number
93-01-03-8636
Health conditions studied
1
Description of health condition studied
Temporomandibular joint disorder
ICD-10 code
M25.8
ICD-10 code description
Other specified joint disorders
Primary outcomes
1
Description
Pain
Timepoint
Each treatment session
Method of measurement
Visual analogue scale
2
Description
Function
Timepoint
Before and After the intervention
Method of measurement
Helkimo index
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group1: TENS" Physiotherapy with TENS (NEURDYN) equipment is performed for 8 sessions(4 consecutive days per week) within 2 weeks. Carbon electrodes (6.5×4.5cm) are placed on the tender and painful muscles with 75 HZ frequency and 0.75 millisecond pulse width for 20 minutes per session.
Category
Treatment - Devices
2
Description
"Intervention group2: Low level laser"Low-power lasers with Azore device apply every other day for 10 sessions, with a dose of 12 J / cm 2 on a temporal joint.