Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000387729
Ethics application status
Approved
Date submitted
18/09/2021
Date registered
7/03/2022
Date last updated
7/03/2022
Date data sharing statement initially provided
7/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate and short term effects of an Osteopathic treatment protocol in patients with temporomandibular disorders (TMD).
Scientific title
Immediate and short term effects of an Osteopathic treatment protocol on mouth opening, trigger points sensivity and baropodometry in patients with temporomandibular disorders (TMD): A Double blind Controlled Longitudinal Clinical Trial.
Secondary ID [1] 304107 0
None
Universal Trial Number (UTN)
U1111-1266-8086
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myogenic Temporomandibular Disorder 321788 0
Condition category
Condition code
Musculoskeletal 319517 319517 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 319899 319899 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each patient will receive the 10 techniques that I describe below in each of the 2 sessions that the patient attends. Each session will last approximately 30 minutes. The second session will take place one week after the first session.
One of the examiners will monitor adherence to the intervention using a checklist.

ARM 1
1. Brief Name: Flexion-Extension Stretching
2. Why: the intervention reduces pain, increases PPT (pressure pain threshold) in masseters and temporalis muscles, and stimulates the central nervous system.
3. Materials: -
4. Procedures: The patient is in supine position with his cervical spine in neutral position. The therapist applies an anterior posterior upper cervical movilization on the 3 upper cervical segment (C0-C3). The movilization will be applied at a rate of 1 oscillation per 2s (0.5Hz). The caudal hand takes the occipital bone. The thumb and the index must touch the transverse atlas process. The other hand is placed over the frontal bone. This hand must push the occipital in the flexion way, while the other keep the atlas still.
5. Who will deliver the intervention: Every technique (both experimental and control) will be applied by a Physical Terapist (with more than 10-year expertise), C.O. (Certificado en Osteopatia with 4-year expertise). The professional has trained in the techniques during the period of development of project (starting in early 2020). Video records of the techniques being applied will be sent to the EOM (Escuela de Osteopatia de Madrid) Director for revision.
6. How: The treatment will be applied individually. This will be the same in every technique.
7. Where: The interventions will take place in an Osteopathic Center in Córdoba City, Argentina. This will be the same in every technique.
8. When and How Much: Both groups (experimental and control) will receive 2 sessions of the protocols. Session 2 will take place one week after Session 1. This will be the same in every technique.
9. Tailoring: - This will be the same in every technique.
10. Modifications: This technique was modified. Hand contact was changed to be as described by the EOM.
11. How Well: Planned: Techniques will be assessed by the Director or any PhD Osteophath from EOM. This will be the same in every technique.
12. Actual: - This will be the same in every technique.

ARM 2:
1. Brief Name: Suboccipital inhibition
2. Why: This technique increases the PPT (Pressure Pain Threshold) over the TrPs (Trigger Points) in the temporalis and masseter muscles.
3. Materials: -
4. Procedures: Patient is in supine position. The hands of the therapist are behind the head of the subject with the palms facing upwards and the finger flexed with the finger pads positioned on the posterior arch of the atlas. A force is applied on the atlas in the direction of the ceiling, with a slight traction in a cranial direction for 2 minutes.

ARM 3:
1. Brief Name: Bilateral OAA (Occipital Atlas Axis).
2. Why: the application of an atlantoaxial joint thrust manipulation results in an
increase in active mouth opening and PPT over a trigeminal nerve distribution area.
3. Materials: -
4. Procedures: the patient is supine and the head is rotated to one side. With the middle and the ring finger of one hand, the therapist contacts the mastoid process. With the palm of the other hand, the therapist contacts the patient's jaw line and cheek. A slight traction is cranially introduced with both hands. When joint tension is perceived by the therapist, a high-velocity low-amplitude thrust is performed in the direction of traction with a gentle rotary force. If no popping sound is heard on the first manipulation attempt, the therapist repositions the patient and performs a second manipulation. A maximum of 2 thrust attempts are performed on each patient. The manipulation is performed bilaterally in all patients in the experimental group.

ARM 4:
1. Brief Name: Muscle Energy Technique (MET).
2. Why: To produce an increase in range of motion in temporomandibular joint.
3. Materials: -.
4. Procedures: patient is in supine position and the therapist is seated with the cranial hand stabilizing the head contacting the frontal bone. The caudal hand contacts the chin of the patient. The therapist puts the TMJ in the maximun open passive range and asks to make an isometric contraction for 3 seconds and rest 3 seconds. This is repeated in 3 cycles of 3 contractions of 3 seconds. Between each cycle the therapist must win a new range barrier.

ARM 5:
1. Brief Name: TMJ (Temporomandibular Joint) Movilization.
2. Why: To increase the limited range of motion. Contributes to the immediate improvement of postural control in TMD patients.
3. Materials: Latex gloves.
4. Procedures: The technique is performed with the patient in supine position. The osteopath stands at the other side of the patient. He holds the patient's head by the frontal bone and, with the other hand, mobilizes the mandible with his thumb contacting the 2nd and 3rd molars. The traction is made in a low range, for a minute. There are five repetitions. Between each mobilization the patient must open his mouth 10 times with the tongue contacting the incisive papilla. The side to be treated will be previously determined by the Diagnostic Criteria for Temoporomandibular Disorders (DC/TMD).

ARM 6:
1. Brief Name: Intra-oral Myofascial therapies (IMT).
2. Why: IMT alone or with the addition of self-care may be of some benefit in the management of chronic TMD over the short-medium term.
3. Materials: Latex Gloves.
4. Procedures: a) Intra-oral temporalis release. The therapist is positioned homolateral to the side being treated. A gloved index contact of the caudal hand is placed onto the coronoid process of the mandible, applying light posterior and caudal pressure within pain tolerance of the patient. The cephalad index and middle fingers apply superior pressure longitudinally along the fibres of the temporalis muscle moving gradually anteriorly to posteriorly. The patient is asked to incrementally open their mouth to its maximum range.
b) Intra-oral medial and lateral pterygoid (origin) technique. The practitioner is seated either homolateral or contralateral to the side being treated. A gloved index finger is inserted along the lateral wall of the pharynx, posterior to the last molar. Posterior and cephalad pressure is applied into the pharyngeal tissues overlying the pterygoid origins arising from the lateral pterygoid plate of the sphenoid. Contact is maintained for 5 seconds.

ARM 7:
1.Brief Name: Hyoid Bone functional technique.
2. Why: This technique was developed by Richard, from EOM. It reduces anterior neck fascia tension.
3: Materials: -.
4. Procedure: The patient rests in supine position and the therapist is seated next to the shoulder. 1st stage: Functional Phase: the mandibular hand makes a bilateral compression in the upside direction of 5grs in the temporomandibular joint and leaves the mandibula balanced with the temporal bones. Then, the hyoid hand balances the hyoid bone where there is less tension in 3 dimensions (upside down, front an back side and left-right side). Structural Phase: it reverses the order of the parameters while the patient breathes widely until the tissues get relaxed.

ARM 8:
1. Brief Name: Tongue technique.
2. Why: It reduces opening mouth pain.
3. Materials: Latex Gloves. Gauze.
4. Procedure:
1st technique: The tongue is held with one hand using a piece of gauze (in order not to release the hold), while the patient is in supine position. The other hand
with the palm open has to be placed behind the head of the patient, in an area that includes the cervical and occipital surface. The tongue must be gently pulled out, until the tension generated is perceived in the occipital–cervical area. This position has to be maintained until tension in the muscular tissue of the tongue and the posterior cervical and occipital
tract is reduced, and a sensation of looseness and lightness is perceived.
For the 2nd technique, with the patient always in supine position, the tongue is held with one hand as previously described, whereas the other hand gently grasps
the hyoid bone. In this position, the therapist waits until the suprahyoid tissue and the tongue reach a balanced tension, resulting in a perception of looseness and lightness.

ARM 9:
1. Brief Name: Myofascial Technique.
2. Why: It produces improvements for pain symptoms.
3. Materials: -.
4. Procedure:
Temporalis muscle: localize the central area of the muscle. The patient rests in supine position with their head turned toward the healthy side. The inferior hand makes index fascial creeping contact over the muscle, while the other hand stabilizes the head. The therapist must deep-massage the muscle until the pain is reduced and the tissues get relaxed.
Masseter muscle: localize the mandibular angle. Same position for the patient and therapist.
10. Modifications: The therapist must localize the trigger points and apply the technique in that area.

ARM 10:
1. Brief Name: Maxillopharynx Fascia Technique.
2. Why: It relaxes fascial tissue.
3. Materials: -.
4. Procedures:
Patient is in supine position. One hand is placed over the sternum, clavicle and the thorax superior part. The other hand contacts the lateral side of the patient's head with flex fingers in the horizontal branch of the mandible, contacting the fascia.
1st time: Fascial Test: the therapist must create tension in the fascial fibers with alternating flexing of the fingers.
2nd time: the thoracic hand follows the costal respiration, pushing the thorax to an exhale position during the patient's deep exhale until the therapist feels the repercussion in the mandibular fingers. This must be repeated until the tension is reduced.
Intervention code [1] 321129 0
Treatment: Other
Intervention code [2] 321130 0
Rehabilitation
Comparator / control treatment
Each patient will receive the 3 techniques that I describe below in each session. Each session will last approximately 30 minutes. The second session will take place one week after the first session. As for the mode of delivery, the therapist will apply the techniques on each patient (one-on-one).
One of the examiners will monitor adherence to the intervention using a checklist.

ARM 1
1. Brief Name: Ultrasound Therapy
2. Why: Therapeutic ultrasound produces an inmediate increase in pressure pain thresholds (PPT) for the masseter and improves mouth opening.
3. Materials: 1 MHz ultrasound. Neutral Gel.
4. Procedures: the patient is in supine position. The therapist spreads neutral gel over the masseter area. The utrasound parameters are: "Muscle relax" modality, continuous frequency and 1.6W/cm2 intensity. 10 minutes on each masseter.
5. Who will deliver the intervention: Every technique (both experimental and control) will be applied by a Physical Terapist (with more than 10-year expertise), C.O. (Certificado en Osteopatia with 4-year expertise). The professional has trained in the techniques during the period of development of project (starting in early 2020). Video records of the techniques being applied will be sent to the EOM (Escuela de Osteopatia de Madrid) Director for revision.

ARM 2
1. Brief Name: Active Mouth Opening.
2. Why: It is recommended to add active exercises after ultrasound therapy.
3. Materials: -.
4. Procedures: The patient must make 3 series of 10 repetitions of 6 seconds of maximun mouth opening. 1 minute rest between each series.

ARM 3
1. Brief Name: Active Lateral Mouth movement.
2. Why: It is recommended to add active exercises after ultrasound therapy.
3. Materials: -.
4. Procedures: The patient must make 3 series of 10 repetitions each side of 6 seconds of lateral movement. 1 minute rest between each series.
Control group
Active

Outcomes
Primary outcome [1] 328229 0
Maximum Mouth Opening (MMO). This will be measured according to DC/TMD. With the patient sitting upright, a caliper will be used to measure the interincisive distance between the reference upper and lower teeth. The patient will be asked to open their mouth as much as possible, regardless of any pain they may feel.
Timepoint [1] 328229 0
Immediately after 1st and 2nd session of treatment and 1 month (4 weeks) after the 1st session.
Primary outcome [2] 328230 0
Pressure Pain Threshold (PPT) in masseter and temporalis muscle. This will be assessed using a dynamometer.
Bilateral. This measure will be conducted making sure the examiner is unable to see the display in order to avoid any conditioning on the part of said examiner. The PEAK feature will be on, so that the maximum pressure value can be registered, at which point the trigger point will be released and the measure logged (temporalis muscle, 3 points: anterior, middle and posterior fibres; and masseters, 3 points: origin, insertion and middle area).

The therapist starts with a palpation applying the DC/TMD protocol in order to localize the compromised muscles. The palpation will be conducted applying a 1-KG pressure; the examiner having been previously trained for better sensitivity. The following instructions will be given to the patient:
"Now I will apply pressure on different areas of your head, face and mandible, and I will ask you about pain, family pain, and family headache. I will also ask whether the pain was restricted to where my finger was, or whether you felt it elsewhere. I will apply and maintain pressure for 5 seconds each time."

The affected muscles will be identified, and then an dynamometer will be used to measure the intensity of pain with a patient sitting on a chair as farthest behind as possible and with the back on the backrest.
Timepoint [2] 328230 0
Immediately after 1st and 2nd session of treatment and 1 month (4 weeks) after the 1st session
Secondary outcome [1] 398184 0
Visual Analog Scale (VAS).
The patient will be told:
"Please rate your facial pain at this precise moment, spontaneously. Use a scale ranging from 0 to 10, where 0 means NO PAIN and 10 means THE WORST PAIN I COULD FEEL."
Timepoint [1] 398184 0
Immediately after 1st and 2nd session of treatment and 1 month (4 weeks) after the 1st session
Secondary outcome [2] 398185 0
Baropodometric Values (composite secondary outcome):
* Gravity objective centre.
* Pressure ratio.
* Movement Area.
* Postural Score.

The patient will be asked as follows:
"Please stand on the platform making sure you are standing comfortably, with arms relaxed on either side of the body, your eyes open, and looking at the wall (without fixing your view at any specific point)".

No indications for the patient to remain in an upright position will be given, nor will be any instructions regarding occlusal contact or tongue position, given that said changes will alter the baropodometric values. The intent is to achieve a spontaneous position in accordance with the adjustments used by the patient, and the conduct the post-test in the same manner. The platform will be 150 cm away from and facing the wall. Data will be collected during 30 seconds. The patient will have been previously asked not to have taken any alcohol or engaged in physical activities during the 24 hours immediately preceding the assessment.
Timepoint [2] 398185 0
Immediately after 1st and 2nd session of treatment and 1 month (4 weeks) after the 1st session

Eligibility
Key inclusion criteria
Myogenic Temporomandibular Disorders (TMD)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Head or neck surgery history.
* Cancer in the last 5 years.
* Having received osteopathic treatment in the last month.
* Crossbite, open bite, underbite or overbite.
* Having consumed analgesic, anti-inflammatory or any muscle relax medication in the last 72 hours.
* Psychiatric or neurological conditions.
* Inflammatory systemic disease.
* Malformations.
* Cervicocephalic historical trauma or whiplash.
* Lacking teeth (except 18, 28, 38, 48 dental pieces).
* Articular TMD origin (meniscal, joint lock, arthritis).
* Muscular TMD origin out of myalgia sub-classification.
* Traumatic foot history in the last month.
* Blindness.
* Non-myogenic headache.
* Cervical instability.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/04/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 24018 0
Argentina
State/province [1] 24018 0
Córdoba

Funding & Sponsors
Funding source category [1] 308490 0
Self funded/Unfunded
Name [1] 308490 0
Juan Ignacio Lapilli
Country [1] 308490 0
Argentina
Primary sponsor type
Individual
Name
Juan Ignacio Lapilli
Address
Name: Consultorios Kimé
Address: Almirante Guillermo Brown 130 PB B, Córdoba Capital, Argentina, CP: 5003
Country
Argentina
Secondary sponsor category [1] 309338 0
None
Name [1] 309338 0
Address [1] 309338 0
Country [1] 309338 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308443 0
Tribunal de Ética y Disciplina Colegio Profesional de Kinesiólogos y Fisioterapeutas de la Provincia de Córdoba
Ethics committee address [1] 308443 0
Calle Gral. Juan B. Bustos 470,
Bº Cofico, X5000GQJ, Córdoba.
Ethics committee country [1] 308443 0
Argentina
Date submitted for ethics approval [1] 308443 0
27/08/2021
Approval date [1] 308443 0
17/09/2021
Ethics approval number [1] 308443 0
Resolución N.º 024/2021

Summary
Brief summary
Introduction: Myogenic Temporomandibular Disorders (TMD) are disorders in the Temporomandibular Joint (TMJ) which are characterized by a pain, a limited range of motion and pressure pain sensitivity in the masticatory muscles. Research is currently being conducted on different kinds of treatments like physiotherapy, massage, acupuncture, drugs and others techniques with limited efficacy in this problem.

Objectives: The objective of this trial is to study the efficacy (both immediate and in the short term) of an osteopathic treatment protocol, the possible relation between opening mouth range, trigger points sensitivity and baropodometry in myogenic TMD patients, as well as measurable effects, compared with a physiotherapy conventional treatment.

Materials & methods: The population will be calculated to be representative. It will be comprised of patients of either sex, aged 18 to 50. Patients will be randomly assigned into one of two groups, as follows: an experimental group will participate in two sessions; in each of them, the therapist will deliver the osteopathic treatment protocol. The relevant variables will be measured by a physical therapist before the treatment. The physical therapist must have experience or will be trained for assessment for baropodometry, maximum active open mouth and pressure pain thresholds (PPTs). The evaluator will be blinded about whether patients have received the intervention or control treatment. The second group — the control group — will receive conventional physiotherapy treatment.
Our hypothesis is that the Osteopathic treatment is more effective than the conventional physiotherapy treatment to treat myogenic TMDs.

Key words: temporomandibular joint (TMJ), temporomandibular joint disorder (TMD), musculoskeletal manipulations, myofascial pain Syndromes, neck pain, posture, protocol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110730 0
Mr Juan Ignacio Lapilli
Address 110730 0
Almirante Brown 130 PB B CP 5003, Córdoba Capital, Córdoba, "Consultorios KIME"
Country 110730 0
Argentina
Phone 110730 0
+54 0351 153271961
Fax 110730 0
Email 110730 0
[email protected]
Contact person for public queries
Name 110731 0
Mr Juan Ignacio Lapilli
Address 110731 0
Almirante Brown 130 PB B CP 5003, Córdoba Capital, Córdoba, "Consultorios KIME"
Country 110731 0
Argentina
Phone 110731 0
+54 0351 153271961
Fax 110731 0
Email 110731 0
[email protected]
Contact person for scientific queries
Name 110732 0
Mr Juan Ignacio Lapilli
Address 110732 0
Almirante Brown 130 PB B CP 5003, Córdoba Capital, Córdoba, "Consultorios KIME"
Country 110732 0
Argentina
Phone 110732 0
+54 0351 153271961
Fax 110732 0
Email 110732 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The following outcome measurements for individual patients (both pre- and post-treatment) will be available on request:
Visual Analogic Scale (VAS)
Pressure Pain Threshold (PPT)
Maximum Mouth Opening (MMO)
Baropodometric values
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Case-by-case basis at the discretion of Principal Investigator.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.
Contact: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



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