Temporomandibular DisorderNCT03556150
Effectiveness of a Manual Therapy Protocol in Patients With Masticatory Muscle Disorders
A study testing Manual Therapy protocol and Effleurage in people with Temporomandibular Disorder, run by University of Alcala at 1 site in Spain.
Trial summary
Comparing the efficiency between manual therapy protocol and effleurage in patients with temporomandibular disorders. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Manual Therapy protocol and Effleurage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2018to 3 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are between 18 and 60 years old.
- Patients who have myofascial pain or myofascial pain and restricted oral opening taking into account Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
- Patients who have pain in their masticatory muscles while they are doing functional activities with their temporomandibular joint for, at least, the last six months.
Who cannot join
- Patients who cannot receive manual therapy.
- Patients who took or have been taking pills in the last two months before they start in the trial like: antidepressants, antiepileptics, muscle relaxants or medications for metabolic diseases; because they affect the musculoskeletal system.
- Surgery intervention in the temporomandibular joint.
- Patients who have received physiotherapy sessions in the last six months.
- Red flags: malignant or inflammatory tumors, infectious diseases that contraindicate manual therapy, cervical surgery, previous history of whiplash, fibromyalgia, trigeminal neuralgia, osteoarthritis or rheumatoid arthritis.
- Patients who lost their teeth (excluding the third molar) or people using a total or partial dentures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Manual Therapy Protocol in Patients With Masticatory Muscle Disorders: A Randomized Controlled Trial
Comparing the efficiency between manual therapy protocol and effleurage in patients with temporomandibular disorders.
Read the detailed description
The investigators want to get better insights into the outcome of a manual therapy protocol compare with effleurage. The treatment is meant for people who has masticatory muscle disorders. Besides, if the trial can reduce the pain's intensity and the trial can improve range of motion in the dysfunction of temporomandibular joint. The results will be register on the short and long term.
- Conditions
- Temporomandibular Disorder
- Being tested
- Manual Therapy protocol, Effleurage
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy protocolOther
This protocol consists of:
- Six minutes of joint's mobilisation (two minutes of each technique).
- Nine minutes of ischemic pressure . Three minutes per muscle in this order: temporal muscle, masseter muscle and lateral pterygoid. Choosing the two most painful trigger points.
- Three minutes of trigemino's nerve stretching.
EffleurageOther
The protocol consists of:
- Five minutes in temporal muscle.
- Ten minutes superficial massage in the neck and cheek of the most painful joint.
- Five minutes of effleurage in the cheek, with the index finger inside the mouth and the thumb outside.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy protocol | Experimental | Massages, mobilisation and stretching techniques in the most painful joint Receives: Other: Manual Therapy protocol |
| Effleurage | Active comparator | Superficial massage in the most painful joint. Receives: Other: Effleurage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
It's an instrument to measure subjective pain intensity. It consists of a horizontal line of ten centimetres in length. On the left side appears the description of "no pain" and on the right side "the worst unimaginable pain". The patient is asked to draw a line at the point where he would place the intensity of his pain. Subsequently, it will be measured with a millimeter ruler from the left end to the point indicated by the patient. It will be the way to express in millimeters the intensity of pain. A minimum change of between 1.5 and 2.4 is required to be clinically significant, taking as reference the significant minimum change of subjects with nonspecific neck pain.
Measured: Measurements will be taken before the treatment starts, one hour after the last session, fifteen days after the last session and one month after the last session.
Oral opening
It will use a rule of fifteen centimetres (starting from 0), to measure the maximum painless opening and the maximum total opening. The opening will be the measurement that is between the lower part of the incisors of the upper jaw and the upper part of the incisors of the lower jaw, not counting the vertical overbite. The patient will be asked to open their mouth as much as possible without pain and also as much as possible until their pain tolerance. It will be analyzed taking three measurements with a rest's interval of 30 seconds. The three measurements will be added up and the average will be taken to obtain the final result. The minimum detectable change to be clinically significant is 5 to 9 mm.
Measured: Measurements will be taken before the treatment starts, one hour after the last session, fifteen days after the last session and one month after the last session.
Pressure algometry measurement
It measures the pain of the main masticatory muscles (temporal muscle, masseter muscle and lateral pterygoid muscle). The pain's pressure is analyzed three times at each point. The three measurements will be added up and the average will be taken to obtain the final result.
The patient is in supine, the investigators apply the tip of the algometer perpendicular to the muscle maintaining a pressure, which will progressively increase up to 1kg / cm2. Participants will be instructed to make a nonverbal signal at the time they start to experience pain, in order to obtain an accurate record. The minimum detectable change to be clinically significant is 1.13kg / cm2, taking as reference the nonspecific neck pain.
Measured: Measurements will be taken before the treatment starts, one hour after the last session, fifteen days after the last session and one month after the last session.
Secondary outcomes (1)
Self-perceived effect
The effect and the level of patients' satisfaction will be measured, through a scale of 11 points. Patients will draw a circle depending on the change they have experienced from -5 (much worse), passing through 0 (unchanged) to the +5 (full recovery).
Measured: Measurements will be taken one hour after the last session and one month after the last session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start15 Jun 2018
- Primary completion3 Sep 2018
- Study completion3 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Martín Bravo, University of Alcala
- Investigators
- Beatriz M. Bravo, Physiotherapy, Principal investigator, InvestigatorInmaculada T. Tejada, Physiotherapy, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556150
- Sponsor's protocol ID
- CEIM/HU/2018/05
- Status last verified
- Sep 2018
- First submitted
- 2 Jun 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Manual Therapy Protocol in Patients With Masticatory Muscle Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03556150
- Acronym / sponsor ID
- CEIM/HU/2018/05
- Conditions
- Temporomandibular Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 3 Sep 2018 (actual)
- Study completion
- 3 Sep 2018 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing the efficiency between manual therapy protocol and effleurage in patients with temporomandibular disorders.
Detailed description
The investigators want to get better insights into the outcome of a manual therapy protocol compare with effleurage. The treatment is meant for people who has masticatory muscle disorders. Besides, if the trial can reduce the pain's intensity and the trial can improve range of motion in the dysfunction of temporomandibular joint. The results will be register on the short and long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy protocol | Experimental | Other: Manual Therapy protocolMassages, mobilisation and stretching techniques in the most painful joint |
| Effleurage | Active comparator | Other: EffleurageSuperficial massage in the most painful joint. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who are between 18 and 60 years old.
- Patients who have myofascial pain or myofascial pain and restricted oral opening taking into account Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
- Patients who have pain in their masticatory muscles while they are doing functional activities with their temporomandibular joint for, at least, the last six months.
Key exclusion criteria (6 listed)
- Patients who cannot receive manual therapy.
- Patients who took or have been taking pills in the last two months before they start in the trial like: antidepressants, antiepileptics, muscle relaxants or medications for metabolic diseases; because they affect the musculoskeletal system.
- Surgery intervention in the temporomandibular joint.
- Patients who have received physiotherapy sessions in the last six months.
- Red flags: malignant or inflammatory tumors, infectious diseases that contraindicate manual therapy, cervical surgery, previous history of whiplash, fibromyalgia, trigeminal neuralgia, osteoarthritis or rheumatoid arthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Therapy protocolThis protocol consists of: * Six minutes of joint's mobilisation (two minutes of each technique). * Nine minutes of ischemic pressure . Three minutes per muscle in this order: temporal muscle, masseter muscle and lateral pterygoid. Choosing the two most painful trigger points. * Three minutes of trigemino's nerve stretching. | Other | Manual Therapy protocol |
| EffleurageThe protocol consists of: * Five minutes in temporal muscle. * Ten minutes superficial massage in the neck and cheek of the most painful joint. * Five minutes of effleurage in the cheek, with the index finger inside the mouth and the thumb outside. | Other | Effleurage |
Primary outcome
Visual Analogue Scale
Time frame: Measurements will be taken before the treatment starts, one hour after the last session, fifteen days after the last session and one month after the last session.
It's an instrument to measure subjective pain intensity. It consists of a horizontal line of ten centimetres in length. On the left side appears the description of "no pain" and on the right side "the worst unimaginable pain". The patient is asked to draw a line at the point where he would place the intensity of his pain. Subsequently, it will be measured with a millimeter ruler from the left end to the point indicated by the patient. It will be the way to express in millimeters the intensity of pain. A minimum change of between 1.5 and 2.4 is required to be clinically significant, taking as reference the significant minimum change of subjects with nonspecific neck pain.
Oral opening
Time frame: Measurements will be taken before the treatment starts, one hour after the last session, fifteen days after the last session and one month after the last session.
It will use a rule of fifteen centimetres (starting from 0), to measure the maximum painless opening and the maximum total opening. The opening will be the measurement that is between the lower part of the incisors of the upper jaw and the upper part of the incisors of the lower jaw, not counting the vertical overbite. The patient will be asked to open their mouth as much as possible without pain and also as much as possible until their pain tolerance. It will be analyzed taking three measurements with a rest's interval of 30 seconds. The three measurements will be added up and the average will be taken to obtain the final result. The minimum detectable change to be clinically significant is 5 to 9 mm.
Pressure algometry measurement
Time frame: Measurements will be taken before the treatment starts, one hour after the last session, fifteen days after the last session and one month after the last session.
It measures the pain of the main masticatory muscles (temporal muscle, masseter muscle and lateral pterygoid muscle). The pain's pressure is analyzed three times at each point. The three measurements will be added up and the average will be taken to obtain the final result. The patient is in supine, the investigators apply the tip of the algometer perpendicular to the muscle maintaining a pressure, which will progressively increase up to 1kg / cm2. Participants will be instructed to make a nonverbal signal at the time they start to experience pain, in order to obtain an accurate record. The minimum detectable change to be clinically significant is 1.13kg / cm2, taking as reference the nonspecific neck pain.
1 secondary outcome
Self-perceived effect
Time frame: Measurements will be taken one hour after the last session and one month after the last session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz M. Bravo, Physiotherapy principal investigator
Investigator
Inmaculada T. Tejada, Physiotherapy principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy protocol and Effleurage in people with Temporomandibular Disorder, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Measurements will be taken before the treatment starts, one hour after the last session, fifteen days after the last session and one month after the last session.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.