Temporomandibular Disorder
Conditions
Brief 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.
Interventions
OTHERIntraoral manual therapy
Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.
OTHERExtraoral manual therapy
Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.
OTHERExercise and counselling
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.
Sponsors
University of Alcala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Researchers involved in recording outcome measures will not be aware of treatment allocation. Patients will be encouraged to not tell the evaluators about the received treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain pressure threshold | 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 pressure threshold measured by a digital algometer at several locations of temporomandibular joint. |
| Change in range of movement of the temporomandibular joint | 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. | Active and passive range of movement measured by a digital caliper. |
| Change in quality of life | 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. | 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). |
| Change in disability | 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. | Disability measured with Craniofacial Pain and Disability Inventory (CF-PDI). CF-PDI ranges from 0 (better functional status) to 63 (worse disability). |
| Change in anxiety | 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. | Anxiety measured with State-Trait Anxiety Inventory (STAI). STAI ranges from 20 (lower anxiety) to 80 (greater anxiety). |
Countries
Spain
Contacts
Primary ContactJorge Ballesteros Frutos, PhD student
Backup ContactJorge Ballesteros Frutos
Outcome results
None listed