Temporomandibular Disorders (TMDs)NCT07056725
Quality of Life and Sleep in Patients With Temporomandibular Disorders
A study testing Manual Therapy and Therapeutic Exercises Programs in people with Temporomandibular Disorders (TMDs), run by University of Jaén at 1 site in Spain.
Trial summary
The aim of this study is to evaluate and compare the effects of two physiotherapeutic intervention programs on the quality of life in patients with Temporomandibular Disorders (TMD). Study design: Randomized, longitudinal, and prospective clinical trial with two intervention groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Disorders (TMDs)
- What is being tested?
- Manual Therapy and Therapeutic Exercises Programs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2025to Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 18 and 65 years of age with subacute Temporomandibular Disorders (TMD).
- Diagnosis of TMD based on: The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). And The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- Willingness to participate in the study and signing of the informed consent form.
Who cannot join
- Individuals younger than 18 years or older than 65 years.
- Medical history or systemic conditions, including: Diagnosis of neurological or neuromuscular disorders (such as multiple sclerosis, facial paralysis, trigeminal neuralgia). Systemic or inflammatory joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia). Presence of severe psychiatric disorders. Previous diagnosis of cancer in the craniofacial or cervical region.
- Previous interventions (e.g., surgery involving the TMJ or the orofacial and cervical regions).
- History of trauma in the region, including mandibular trauma, whiplash injuries, or fractures in the area.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Quality of Life and Sleep in Patients With Temporomandibular Disorders. A Protocol for a Randomized Control Trial
The aim of this study is to evaluate and compare the effects of two physiotherapeutic intervention programs on the quality of life in patients with Temporomandibular Disorders (TMD).
Study design: Randomized, longitudinal, and prospective clinical trial with two intervention groups.
Population: Subjects aged 18-65 years with subacute temporomandibular disorders.
Read the detailed description
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 30 subjects with Temporomandibular Disorders (TMD) will be selected and randomly assigned into two intervention groups.
The first group will receive a physiotherapy treatment based on a Manual Therapy program targeting the orofacial region, combined with a Cervical Therapeutic Exercise program. In contrast, the second group will receive a physiotherapy treatment based on a Manual Therapy program for the orofacial region, combined with an Orofacial Therapeutic Exercise program.
Both groups will undergo a total of six treatment sessions over a period of six weeks (1 session per week). Each manual therapy session targeting the orofacial region will last 30 minutes. The manual therapy (MT) techniques will include a combination of neuromuscular and articular manual techniques.
The study will assess the following variables: quality of life, sleep quality, pressure pain threshold, maximum pain-free mouth opening, perceived pain, and treatment adherence.
Measurements will be taken pre-treatment, post-treatment and a follow-up at 8 weeks
- Conditions
- Temporomandibular Disorders (TMDs)
- Being tested
- Manual Therapy and Therapeutic Exercises Programs
- Keywords
- Manual Therapy, Therapeutic Exercise, Quality of life, Quality of Sleep
- Medical subject headings
- Temporomandibular Joint Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy and Therapeutic Exercises ProgramsOther
A treatment based on the combination of Manual Therapy targeting the orofacial region and a therapeutic exercise program focused on either the cervical or orofacial region
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects in this group will receive physiotherapy treatment consisting of a Manual Therapy program targeting the orofacial region, combined with a Cervical Therapeutic Exercise program. The Cervical Therapeutic Exercise program focuses on co-contraction exercises of the flexor and extensor muscles, progressively increasing difficulty and resistance through the use of a latex band (Theraband), along with neural tissue techniques. Receives: Other: Manual Therapy and Therapeutic Exercises Programs |
| Group 2 | Experimental | Subjects in this group will receive physiotherapy treatment consisting of a Manual Therapy program targeting the orofacial region, combined with an Orofacial Therapeutic Exercise program. The Orofacial Therapeutic Exercise program focuses on coordination exercises of the masseter muscles, progressively increasing difficulty and resistance, and is combined with neural tissue techniques. Receives: Other: Manual Therapy and Therapeutic Exercises Programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (SF-12)
The SF-12 consists of a subset of 12 items from the SF-36, covering physical functioning, social functioning, physical role, emotional role, mental health, vitality, bodily pain, and general health. The SF-12 is a shortened version of the SF-36 Health Survey. It is a self-administered questionnaire with a completion time of less than 2 minutes. The response options are based on Likert-type scales that assess intensity or frequency. The number of response options ranges from three to six, depending on the item.
Measured: Pre-intervention, post-intervention (6 weeks) and follow-up of 8 weeks after the end
Sleep Quality (Pittsburgh Sleep Quality Index)
The Pittsburgh Sleep Quality Index (PSQI) is a self-administered instrument designed to assess sleep quality in adults over the past month. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
Measured: Pre- intervation, post-intervention (6 weeks) and follow-up of 8 weeks after the end.
Secondary outcomes (4)
Pain Intensity (NRS)
The Numerical Rating Scale (NRS) is a widely used instrument for the subjective assessment of pain intensity.
It consists of a numerical scale from 0 to 10, where 0 indicates no pain and 10 represents the highest intensity. Patients select the number that best reflects the severity of their symptom.
Measured: Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end
Pressure Pain Threshold (PPT)
The tip of the algometer will be applied perpendicularly to the muscle (anterior portion of the temporalis muscle and the superficial belly of the masseter muscle), and pressure will be gradually increased at a rate of 1 kg/sec. Participants will be instructed to signal the moment they first perceive pain, in order to accurately record the pressure pain threshold.
Measured: Pre- intervention, post- interventio (6 weeks) and follow-up of 8 weeks after the end.
Maximum Pain-Free Mouth Opening (MPMO)
MPMO is a clinical measure used to assess mandibular function in patients with temporomandibular disorders (TMD). This variable evaluates the ability to open the mouth without experiencing pain, reflecting the functional status of the temporomandibular joint and the associated musculoskeletal structures.
Measured: Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end.
Treatment Adherence
A personalized diary will be provided for each participant in both groups. Each program will include an exercise log that patients will be required to complete.
Measured: Post- intervention (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMDs)Studies 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
- Model description
- An experimental study is proposed in the form of a Randomized Controlled Trial (RCT), longitudinal and prospective in design, with two intervention groups. Patients with Temporomandibular Disorders (TMD) will be randomly assigned to two intervention groups (G1 and G2), ensuring that participants in both groups present with similar baseline characteristics. The 25 requirements proposed by the CONSORT declaration will be followed
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Achalandabaso, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056725
- Sponsor's protocol ID
- CEIM/2025/3
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2025
- Last updated
- 9 Jul 2025
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Sleep in Patients With Temporomandibular Disorders. A Protocol for a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07056725
- Acronym / sponsor ID
- CEIM/2025/3
- Conditions
- Temporomandibular Disorders (TMDs)
- Keywords
- Manual Therapy, Therapeutic Exercise, Quality of life, Quality of Sleep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 9 Jul 2025 (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 study is to evaluate and compare the effects of two physiotherapeutic intervention programs on the quality of life in patients with Temporomandibular Disorders (TMD).
Study design: Randomized, longitudinal, and prospective clinical trial with two intervention groups.
Population: Subjects aged 18-65 years with subacute temporomandibular disorders.
Detailed description
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 30 subjects with Temporomandibular Disorders (TMD) will be selected and randomly assigned into two intervention groups.
The first group will receive a physiotherapy treatment based on a Manual Therapy program targeting the orofacial region, combined with a Cervical Therapeutic Exercise program. In contrast, the second group will receive a physiotherapy treatment based on a Manual Therapy program for the orofacial region, combined with an Orofacial Therapeutic Exercise program.
Both groups will undergo a total of six treatment sessions over a period of six weeks (1 session per week). Each manual therapy session targeting the orofacial region will last 30 minutes. The manual therapy (MT) techniques will include a combination of neuromuscular and articular manual techniques.
The study will assess the following variables: quality of life, sleep quality, pressure pain threshold, maximum pain-free mouth opening, perceived pain, and treatment adherence.
Measurements will be taken pre-treatment, post-treatment and a follow-up at 8 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An experimental study is proposed in the form of a Randomized Controlled Trial (RCT), longitudinal and prospective in design, with two intervention groups. Patients with Temporomandibular Disorders (TMD) will be randomly assigned to two intervention groups (G1 and G2), ensuring that participants in both groups present with similar baseline characteristics. The 25 requirements proposed by the CONSORT declaration will be followed
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Manual Therapy and Therapeutic Exercises ProgramsSubjects in this group will receive physiotherapy treatment consisting of a Manual Therapy program targeting the orofacial region, combined with a Cervical Therapeutic Exercise program. The Cervical Therapeutic Exercise program focuses on co-contraction exercises of the flexor and extensor muscles, progressively increasing difficulty and resistance through the use of a latex band (Theraband), along with neural tissue techniques. |
| Group 2 | Experimental | Other: Manual Therapy and Therapeutic Exercises ProgramsSubjects in this group will receive physiotherapy treatment consisting of a Manual Therapy program targeting the orofacial region, combined with an Orofacial Therapeutic Exercise program. The Orofacial Therapeutic Exercise program focuses on coordination exercises of the masseter muscles, progressively increasing difficulty and resistance, and is combined with neural tissue techniques. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults between 18 and 65 years of age with subacute Temporomandibular Disorders (TMD).
- Diagnosis of TMD based on: The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). And The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- Willingness to participate in the study and signing of the informed consent form.
Key exclusion criteria (5 listed)
- Individuals younger than 18 years or older than 65 years.
- Medical history or systemic conditions, including: Diagnosis of neurological or neuromuscular disorders (such as multiple sclerosis, facial paralysis, trigeminal neuralgia). Systemic or inflammatory joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia). Presence of severe psychiatric disorders. Previous diagnosis of cancer in the craniofacial or cervical region.
- Previous interventions (e.g., surgery involving the TMJ or the orofacial and cervical regions).
- History of trauma in the region, including mandibular trauma, whiplash injuries, or fractures in the area.
- Pregnant or breastfeeding women.
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 and Therapeutic Exercises ProgramsA treatment based on the combination of Manual Therapy targeting the orofacial region and a therapeutic exercise program focused on either the cervical or orofacial region | Other | Group 1, Group 2 |
Primary outcome
Quality of Life (SF-12)
Time frame: Pre-intervention, post-intervention (6 weeks) and follow-up of 8 weeks after the end
The SF-12 consists of a subset of 12 items from the SF-36, covering physical functioning, social functioning, physical role, emotional role, mental health, vitality, bodily pain, and general health. The SF-12 is a shortened version of the SF-36 Health Survey. It is a self-administered questionnaire with a completion time of less than 2 minutes. The response options are based on Likert-type scales that assess intensity or frequency. The number of response options ranges from three to six, depending on the item.
Sleep Quality (Pittsburgh Sleep Quality Index)
Time frame: Pre- intervation, post-intervention (6 weeks) and follow-up of 8 weeks after the end.
The Pittsburgh Sleep Quality Index (PSQI) is a self-administered instrument designed to assess sleep quality in adults over the past month. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
4 secondary outcomes
Pain Intensity (NRS)
Time frame: Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end
Pressure Pain Threshold (PPT)
Time frame: Pre- intervention, post- interventio (6 weeks) and follow-up of 8 weeks after the end.
Maximum Pain-Free Mouth Opening (MPMO)
Time frame: Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end.
Treatment Adherence
Time frame: Post- intervention (6 weeks)
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 9 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Disorders (TMDs)
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
RecruitingObservational study
Spinal Mobility, Rigidity, and Kinesiophobia in PD and TMD
PARKINSON DISEASE (Disorder), Rigidity
Not yet recruiting
Effects of Orofascial Myofunctional Therapy and Cervical Stabilization Exercises on Temporomandibular Dysfunction
Temporomandibular Disorders (TMDs), Temporo-mandibular Dysfunction
Not yet recruiting
Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
Temporomandibular Disorders (TMDs), Myofascial Pain - Dysfunction Syndrome of TMJ
Not yet recruitingObservational study
The Italian Version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)
Temporomandibular Disorders (TMDs), Kinesiophobia
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 Manual Therapy and Therapeutic Exercises Programs in people with Temporomandibular Disorders (TMDs), run by University of Jaén 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 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: opening soon, as of the sponsor's last update on 9 Jul 2025. 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 Jaime Martínez Barros (+ 34 686052159, fisiojmb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (SF-12) (time frame: Pre-intervention, post-intervention (6 weeks) and follow-up of 8 weeks after the end). The study lists 2 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 9 Jul 2025.