Temporomandibular DisorderNCT05167656
Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders
A study testing Intraoral manual therapy, Extraoral manual therapy and Exercise and counselling in people with Temporomandibular Disorder, run by University of Alcala at 1 site in Spain.
Trial summary
The aim of this randomized controlled trial is to evaluate the effects of intraoral manual therapy versus extraoral manual therapy and compare them with a control group, in the management of patients with temporomandibular disorders regarding pain, strength, quality of life, disability and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Intraoral manual therapy, Extraoral manual therapy and Exercise and counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 12 Apr 2022to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral temporomandibular pain for more than one month.
- Older than eighteen.
- No previous treatment to temporomandibular pain in the last 3 months.
- Diagnosed based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
Who cannot join
- Patients with cervical or cranial trauma or whiplash.
- Diagnosed with systemic disease, like rheumatoid arthritis or fibromyalgia.
- Diagnosed of any vascular or metabolic disease.
- Previous cervical or temporomandibular surgery.
- Dental, medicine or any physical therapy treatment in the last 3 months before the beginning of the interventions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Alcalá
Alcalá de Henares, Madrid, 28805
Jorge Ballesteros, PhD Student, 638332255, jorgeballes10@gmail.com
About this study
Official title: Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders. A Randomized Controlled Trial
The aim of this randomized controlled trial is to evaluate the effects of intraoral manual therapy versus extraoral manual therapy and compare them with a control group, in the management of patients with temporomandibular disorders regarding pain, strength, quality of life, disability and anxiety.
- Conditions
- Temporomandibular Disorder
- Being tested
- Intraoral manual therapy, Extraoral manual therapy, Exercise and counselling
- 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.
Intraoral manual therapyOther
Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.
Extraoral manual therapyOther
Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.
Exercise and counsellingOther
Information about etiology, contributing and related factors, natural history and prognostic of the pathology of temporomandibular disorders.
Counselling based on: diet, habits like tabacism, stress and anxiety control, physical activity and awareness of dental clenching.
Exercise daily program based on active and passive mobility of the temporomandibular joint, stretching exercises and self massage.
| Study group | Role | What they receive |
|---|---|---|
| Intraoral Manual Therapy plus exercise and education. | Experimental | Six sessions of intraoral manual therapy plus exercise and counselling. Receives: Other: Intraoral manual therapy; Other: Exercise and counselling |
| Extraoral Manual Therapy plus exercise and education. | Experimental | Six sessions of extraoral manual therapy plus exercise and counselling. Receives: Other: Extraoral manual therapy; Other: Exercise and counselling |
| Exercise and education. | Active comparator | Exercise and counselling alone without any manual therapy treatment. Receives: Other: Exercise and counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
Pain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain)
Measured: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Secondary outcomes (5)
Change in pain pressure threshold
Pain pressure threshold measured by a digital algometer at several locations of temporomandibular joint.
Measured: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Change in range of movement of the temporomandibular joint
Active and passive range of movement measured by a digital caliper.
Measured: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Change in quality of life
Quality of life measured with Short Form Health Survey (SF-12). SF-12 ranges from 0 (poor quality of life) to 100 (great quality of life).
Measured: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Change in disability
Disability measured with Craniofacial Pain and Disability Inventory (CF-PDI). CF-PDI ranges from 0 (better functional status) to 63 (worse disability).
Measured: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Change in anxiety
Anxiety measured with State-Trait Anxiety Inventory (STAI). STAI ranges from 20 (lower anxiety) to 80 (greater anxiety).
Measured: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start12 Apr 2022
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Ballesteros Frutos, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167656
- Sponsor's protocol ID
- CEID/2021/4/087
- Status last verified
- May 2024
- First submitted
- 22 Nov 2021
- Last updated
- 14 May 2024
- Results posted
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05167656
- Acronym / sponsor ID
- CEID/2021/4/087
- Conditions
- Temporomandibular Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Dec 2021 (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.
The aim of this randomized controlled trial is to evaluate the effects of intraoral manual therapy versus extraoral manual therapy and compare them with a control group, in the management of patients with temporomandibular disorders regarding pain, strength, quality of life, disability and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intraoral Manual Therapy plus exercise and education. | Experimental | Other: Intraoral manual therapy, Other: Exercise and counsellingSix sessions of intraoral manual therapy plus exercise and counselling. |
| Extraoral Manual Therapy plus exercise and education. | Experimental | Other: Extraoral manual therapy, Other: Exercise and counsellingSix sessions of extraoral manual therapy plus exercise and counselling. |
| Exercise and education. | Active comparator | Other: Exercise and counsellingExercise and counselling alone without any manual therapy treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral temporomandibular pain for more than one month.
- Older than eighteen.
- No previous treatment to temporomandibular pain in the last 3 months.
- Diagnosed based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
Key exclusion criteria (5 listed)
- Patients with cervical or cranial trauma or whiplash.
- Diagnosed with systemic disease, like rheumatoid arthritis or fibromyalgia.
- Diagnosed of any vascular or metabolic disease.
- Previous cervical or temporomandibular surgery.
- Dental, medicine or any physical therapy treatment in the last 3 months before the beginning of the interventions.
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 |
|---|---|---|
| Intraoral manual therapySix intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral. | Other | Intraoral Manual Therapy plus exercise and education. |
| Extraoral manual therapySix extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral. | Other | Extraoral Manual Therapy plus exercise and education. |
| Exercise and counsellingInformation about etiology, contributing and related factors, natural history and prognostic of the pathology of temporomandibular disorders. Counselling based on: diet, habits like tabacism, stress and anxiety control, physical activity and awareness of dental clenching. Exercise daily program based on active and passive mobility of the temporomandibular joint, stretching exercises and self massage. | Other | Exercise and education., Extraoral Manual Therapy plus exercise and education., Intraoral Manual Therapy plus exercise and education. |
Primary outcome
Change in pain intensity
Time frame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Pain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain)
5 secondary outcomes
Change in pain pressure threshold
Time frame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Change in range of movement of the temporomandibular joint
Time frame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Change in quality of life
Time frame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Change in disability
Time frame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Change in anxiety
Time frame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoral manual therapy, Extraoral manual therapy and Exercise and counselling 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 14 May 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge Ballesteros Frutos, PhD student (638332255, jorgeballes10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (time frame: Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.). 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 14 May 2024.