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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Therapy and Therapeutic Exercises Programs | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Pre- intervation, post-intervention (6 weeks) and follow-up of 8 weeks after the end. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaime MartÃnez Barros | Contact | + 34 686052159 | fisiojmb@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Alcalá De Henares | Madrid | Alcalá de Henares | 28801 | Spain |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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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
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| 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. | 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. | 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. | Post- intervention (6 weeks) |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |