Comparison of dry needling and sham dry needling effectiveness on pain, range of motion and pressure pain threshold in patients with temporomandibular joint dysfunction after dental procedure
Determining the effectiveness of dry needling on myofascial pain of temporomandibular joint as well as range of motion in patients with mobility impairment after dentistry
Design
The randomized control trial has a control group with a parallel double-blind randomized group, on 56 patients that will use the block balanced randomization method.
Settings and conduct
The study in the Nafis physiotherapy clinic, after randomization and collection of initial information, will be performed by dry needling in the intervention group and sham dry needling in the control group in two sessions with an interval of one week.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Men and women 20-50 years old. One week or a months interval from the onset of symptoms and limited range of motion following a visit to the dentist with or without medication. Not performing physiotherapy on the head and neck for the past 12 months. No scar tissue, infection, wound or inflammation on trigger point area. Do not use addictive substances and alcohol due to rising pain threshold. Restriction of mouth opening less than 30 mm or pain with Numeric Rating Scale above 3.
Exclusion criteria:Both side pain. History of clenching while sleeping or night guard using. Temporomandibular joint (TMJ) degenerative disease. Inflammation in mouth, History of TMJ or dental surgery. History of systemic or metabolic disorders, such as metabolic syndrome Rheumatoid arthritis, atypical fascial pain, neuralgia and fibromyalgia. Instability in chewing structures. Orthodontic treatment. Anticoagulant therapy. Pregnancy
Intervention groups
The intervention group is treated with dry needling therapy by a second physiotherapist in the master, temporalis, internal and external pterygoids muscles. People in the placebo group are also subjected to sham dry needling.
Main outcome variables
Range of motion, pain, pressure pain threshold
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200927048859N1
Registration date:2021-11-23, 1400/09/02
Registration timing:registered_while_recruiting
Last update:2021-11-23, 1400/09/02
Update count:0
Registration date
2021-11-23, 1400/09/02
Registrant information
Name
Nafiseh Zekri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3355 5455
Email address
nafiseh_zekri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dry needling and sham dry needling effectiveness on pain, range of motion and pressure pain threshold in patients with temporomandibular joint dysfunction after dental procedure
Public title
Evaluation of dry needling effectiveness on temporomandibular joint pain and range of motion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women 20-50 years old.
Pain and range of motion limitation on one side of the temporomandibular joint who visit the dentist in the past month or a week.
One week interval from the onset of symptoms and limited range of motion following a visit to the dentist with or without medication.
Not performing physiotherapy on the head and neck for the past 12 months.
No scar tissue, infection, wound or inflammation on trigger point area.
Do not use addictive substances and alcohol due to rising pain threshold.
Restriction of mouth opening less than 30 mm or pain with Numeric Rating Scale above 3
Exclusion criteria:
Both side pain
History of clenching while sleeping or night guard using
Temporomandibular joint (TMJ) degenerative disease
Inflammation in mouth
History of TMJ or dental surgery
History of systemic or metabolic disorders, such as metabolic syndrome
Rheumatoid arthritis, atypical fascial pain, neuralgia and fibromyalgia
Instability in chewing structures
Orthodontic treatment
Anticoagulant therapy
Pregnancy
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process will be done through closed envelopes and block balanced randomization method. First of all, the first physiotherapist considers all possible aabb arrangements and using a random number table, randomly selects 10 blocks and writes their components one after the other. Each of these components will then be placed in a sealed envelope and numbers 1 to 52 will be recorded on the envelope. Since the therapist is not aware of how the groups are assigned until the intervention, the important feature of allocation concealment is observed in this study. On the day of the intervention, the first physiotherapist choose the envelopes one by one and based on that, places the patients in the intervention group and Placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
The first physiotherapist is blind to the grouping of patients and the second physiotherapist is blind to the data obtained from the assessments of each patient performed by the first physiotherapist. The patient is also blind to which group he or she belongs to. In the control group, a sharp needle-shaped plastic shield is used so that the patient can only feel the sharp object. It should be noted that the patient's eyes are covered in both groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Pain and temporomandibular dysfunction after dental procedure
ICD-10 code
M26.6
ICD-10 code description
Temporomandibular joint disorders
Primary outcomes
1
Description
Pain with Numeric Rating Scale
Timepoint
At the beginning of the study, one week and two weeks after the start of the intervention
Method of measurement
Numeric Rating Scale; The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. “no pain”) to '10' representing the other pain extreme (e.g. “pain as bad as you can imagine” or “worst pain imaginable”).
2
Description
Range of motion of temporomandibular joint
Timepoint
At the beginning of the study, one week and two weeks after the start of the intervention
Method of measurement
goniometer
3
Description
Evaluation of sensitivity of trigger points
Timepoint
At the beginning of the study, one week and two weeks after the start of the intervention
Method of measurement
Digital pressure algometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They are treated with dry needling on masseter, temporalis, internal and external pterygoid muscles. Initially, by touching and pressing the therapist's hand on each muscle, the most sensitive point to touch is found and targeted with a needle. In this way, the special needles enter this sensitive part of the muscle and remain in the muscle for 20 minutes with infrared heat. At first, the patient's eyes are covered with wet cotton so that the infrared light does not bother and the patient is also blind to the intervention.
Category
Treatment - Other
2
Description
Control group: This group is subjected to sham dry needling. Initially, by touching and pressing the therapist's hand in all four muscles of the masseter, temporal, internal and external pterygoid, the most sensitive point to touch is found and targeted by a sharp plastic needle guide to make the patient feel sharp. And infrared heat shines on the face for 20 minutes. Initially, the patient's eyes are covered with wet cotton so that the infrared light does not bother and the patient is also blind to the intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nafis Physiotherapy clinic
Full name of responsible person
Sepideh Paybast
Street address
No.11, Iran building, Akhlaghi St. Sepah Sq. Jomhouri St
City
Qom
Province
Ghoum
Postal code
3716699845
Phone
+98 25 3355 5455
Email
nafiseh_zekri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Sepideh Paybast
Street address
Shahid Lavasani (Saheli) St., Qom, I.R. Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3285 4011
Email
nafiseh_zekri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qom 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
Ghoum University of Medical Sciences
Full name of responsible person
Sepideh Paybast
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
NO.11, Iran building, Akhlaghi St, Sepah Sq, Jomhouri St
City
Qom
Province
Ghoum
Postal code
3716699845
Phone
+98 25 3355 5455
Email
nafiseh_zekri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Nafiseh Zekri
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 11 akhlaqi st. Jomhouri Blvd, sepah sq. Qom Iran
City
Qom
Province
Ghoum
Postal code
3716699845
Phone
+98 25 3355 5455
Fax
Email
Nafiseh_zekri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Nafiseh Zekri
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 11 akhlaqi st. Jomhouri Blvd, sepah sq. Qom Iran
City
Qom
Province
Ghoum
Postal code
3716699845
Phone
+98 25 3355 5455
Fax
Email
Nafiseh_zekri@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Measurement data and results obtained from each person can be shared.
When the data will become available and for how long
Upon completion of the study for 6 months
To whom data/document is available
Researchers on similar subjects
Under which criteria data/document could be used
To use the results of the study and citation for related studies
From where data/document is obtainable
Email researcher in charge.
Dr Sepideh Paybast, sepideh.paybast@yahoo.com
Physiotherapist Nafiseh Zekri, nafiseh_zekri@yahoo.com
What processes are involved for a request to access data/document
Your email will be read and answered within a week.