Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001323112
Ethics application status
Approved
Date submitted
19/07/2019
Date registered
27/09/2019
Date last updated
27/09/2019
Date data sharing statement initially provided
27/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of neuromuscular and Jones techniques on patients with bruxism and associated episodic and chronic tension headaches.
Scientific title
Effect of neuromuscular and Jones techniques on patients with bruxism and associated episodic and chronic tension headaches.
Secondary ID [1] 298783 0
None
Universal Trial Number (UTN)
U1111-1236-3881
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bruxism 313733 0
chronic tension headaches 313734 0
episodic tension headaches 314167 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312137 312137 0 0
Physiotherapy
Oral and Gastrointestinal 312536 312536 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 312537 312537 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention name: It is a non-drug intervention: „Effect of neuromuscular and Jones techniques in patients with bruxism and associated episodic and chronic tension headaches.“

Intervention Description:

The study will include approximately 50 patients, which are going to be put by random
allocation into two groups, the intervention group and control group. The control group
will receive a sham treatment.

Intervention applied to experimental group A:

The researcher will identify the side that has the more sensitive temporal muscle to palpation and will deliver the interventions to that side.

The neuromuscular technique, with the aim of inhibiting the spasms of the temporal muscles, is exercised with the patient in the supine position and the therapist seated at the head of the table. One hand of the therapist applies a pressure to the insertion of the temporal muscle. The other hand comes in contact with the belly of the temporal muscle with the tip of the thumb extended. Next a deep, slow massage is performed in longitudinal sliding the thumb along the temporal muscle. Three strokes are passed over the muscle.

Once the neuromuscular technique is applied, the Jones technique is performed on the same temporal muscle.

The Jones technique, with the objective of suppressing the gamma hyperactivity of the temporal muscle, is performed with the patient in the supine position and the therapist seated at the head of the table. For the left temporal muscle, for example, the left hand of the therapist locates with the index finger the trigger point of the left temporal muscle. The right hand is placed on the right side of the patient's face and grasps the chin with the fingers.
To begin, the middle finger of the left hand will apply pressure on the sensitive point of the left temporal muscle, which in turn triggers pain. Secondly, the right hand holds on to the anterior aspect of the mandible, opens the mouth and creates a lateral stretch of the mandible to the right until the pain of the trigger point disappears. This position is maintained for 90 seconds. Then the jaw is brought slowly to the neutral position. For the right temporal muscle the procedure would be mirrored.

Evaluation applied to experimental group A:
- Location and signaling of the trigger point on the side of the more sensitive temporal muscle
to palpation by the researcher
- The blinded external evaluator takes the pre-intervention measures:
o Craniocervical extension using the goniometer: The patient is sitting in an upright posture. The evaluator is standing next to the patient. The goniometer is placed at 90° with the axis on the external auditory canal. The fixed arm is aligned with the vertical midline of the head. The mobile arm is aligned with the nostrils. The patient is asked for a cervical extension. The measurement of the extension to be taken with fixed arm kept in place and mobile arm staying in line with the nostrils.
o The opening of the mouth by the caliber: The measurement is taken with the patient in the supine position, the head in neutral position, the evaluator on the right side of the patient. The patient is asked to open his mouth to the fullest. The caliber is placed between the central and lower incisors to take the measurement.
o The threshold of pain at the temporal area will be measured by the algometer: The patient is lying in the supine position and the assessor is seated at the head of the patient. The flat circular probe is pushed against the trigger point of the temporal muscle until the pain threshold is reached and measurement taken.

All measurements are taken three times with the average of the three recorded.

o The researcher will perform the neuromuscular technique on the affected muscle and the Jones technique for the affected temporal muscles as described above.
o The blinded external evaluator will take the post-intervention measurements 1, immediately after performing the techniques: craniocervical extension, opening of the mouth and pain threshold to pressure
o The blinded external evaluator will take the post-intervention measurements 2, three days after performing the technique: craniocervical extension, the opening of the mouth and the pain threshold to pressure

Each patient will receive a single session of the intervention lasting approximately 5 minutes.
The blinded external evaluator will enter the pre/post-intervention measurements in an excel spreadsheet. I, the researcher, will perform an audit of the results entered by the external evaluator.
Intervention code [1] 315053 0
Rehabilitation
Intervention code [2] 315385 0
Treatment: Other
Comparator / control treatment
Intervention and evaluation applied to control group B:
For the control group the same steps were followed as in the experimental group, only that the researcher applies a sham treatment by holding the occipital bone for two minutes whilst sitting at the head of table, estimated equivalent time for performing the techniques neuromuscular and Jones.

The measurements and application of the techniques in group A and B will be carried out in the same environment to maintain the sonorous, visual, luminous and temperature characteristics in a stable manner.
Control group
Active

Outcomes
Primary outcome [1] 320779 0
The effectiveness of the neuromuscular and Jones techniques on the temporal muscles in the vertical opening of the mouth. To measure the effectiveness I will use a digital caliber.
Timepoint [1] 320779 0
The results are taken before and after the techniques are applied on the same day. Then three days after performing the technique the results are taken again.
Primary outcome [2] 320780 0
The variation of the pressure pain threshold by using the algometer over the selected point of the temporal muscle after the application of neuromuscular and Jones techniques.
Timepoint [2] 320780 0
The results are taken before and after the techniques are applied on the same day. Then three days after performing the technique the results are taken again.
Primary outcome [3] 320781 0
The effectiveness of neuromuscular and Jones techniques in craniocervical extension. To measure the effectiveness I will use a goniometer.
Timepoint [3] 320781 0
The results are taken before and after the techniques are applied on the same day. Then three days after performing the technique the results are taken again.
Secondary outcome [1] 372836 0
Nil
Timepoint [1] 372836 0
Nil

Eligibility
Key inclusion criteria
- Study pathology: bruxism and chronic or episodic tension headaches
- Sign the informed consent form
- The patient has not received osteopathic treatment at least 1 month before the study.
- The patient has not received medical treatment at least 2 weeks before the study.


Patients suffering from bruxism or dental tightening that meet at least three of the following points:
• Denture wear.
• Irregularities in the opening and / or closing movement.
• Muscle pain on palpation.
• Clicks or crack in opening and / or closing.
• Limitation in the opening of the mouth (less than 40 mm).
• Pain in the temporomandibular joint.

Prior knowledge of suffering from episodic or chronic tension headache, which meets the following symptoms:
• Sensitivity of the pericranial musculature (frontal, temporal, masseter, pterygoid,
sternocleidomastoid, splenius and trapezius) to manual palpation.
• Bilateral location.
• Oppressive or tensive quality (non-pulsating).
• Mild or moderate intensity.
• Does not get worse with regular physical activity.
• Headache lasting 30 minutes to 7 days.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Injuries and / or fractures of the skull, facial mass or the jaw (in the year prior to the study)
- Surgeries of the skull, facial mass or the jaw (less than six months old)
- Rheumatic injuries.
- Osteitis.
- Tumors and metastasis.
- Central or peripheral neurological pathologies.
- Acute inflammatory or infectious diseases.
- Central or local alterations of sensitivity.

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)
Allocation concealment: The random assignment of patients to the intervention group and control group will be carried out by means of sealed white envelopes containing a paper with the letter A or B. The patient will choose an envelope, which only the researcher will open to verify which group the individual will be included. The group will be hidden from the patient and the evaluator in order to minimize possible information biases.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Method of allocation: randomized
Simple randomisation using procedures like coin-tossing and dice-rolling.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2020
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] 21693 0
Spain
State/province [1] 21693 0
ALICANTE

Funding & Sponsors
Funding source category [1] 303339 0
Self funded/Unfunded
Name [1] 303339 0
Denise Klockzin
Country [1] 303339 0
Spain
Primary sponsor type
Individual
Name
Denise Klockzin
Address
Clinica QO
Calle Capitán Segarra 33, bajo izquierda
03004 Alicante
Spain
Country
Spain
Secondary sponsor category [1] 303365 0
None
Name [1] 303365 0
Address [1] 303365 0
Country [1] 303365 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303868 0
FISABIO
Ethics committee address [1] 303868 0
Ethics committee country [1] 303868 0
Spain
Date submitted for ethics approval [1] 303868 0
18/07/2019
Approval date [1] 303868 0
02/08/2019
Ethics approval number [1] 303868 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95082 0
Ms Denise Klockzin
Address 95082 0
Clinica QO
Calle Capitán Segarra 33, bajo izquierda
03004 Alicante
Spain
Country 95082 0
Spain
Phone 95082 0
+34656337831
Fax 95082 0
Email 95082 0
[email protected]
Contact person for public queries
Name 95083 0
Denise Klockzin
Address 95083 0
Clinica QO
Calle Capitán Segarra 33, bajo izquierda
03004 Alicante
Spain
Country 95083 0
Spain
Phone 95083 0
+34656337831
Fax 95083 0
Email 95083 0
[email protected]
Contact person for scientific queries
Name 95084 0
Denise Klockzin
Address 95084 0
Clinica QO
Calle Capitán Segarra 33, bajo izquierda
03004 Alicante
Spain
Country 95084 0
Spain
Phone 95084 0
+34656337831
Fax 95084 0
Email 95084 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
to ensure and reassure each participant of participant privacy


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3252Ethical approval  [email protected]
3253Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.