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Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders

ConditionTemporomandibular Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Alcala

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraoral manual therapy

    Other intervention

    Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.

  • Extraoral manual therapy

    Other intervention

    Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.

  • Exercise and counselling

    Other intervention

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Intraoral Manual Therapy plus exercise and education.Experimental treatment 2 interventions
Group B: Extraoral Manual Therapy plus exercise and education.Experimental treatment 2 interventions
Group C: Exercise and education.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

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.

Secondary outcomes

1

Change in pain pressure threshold

Pain pressure threshold measured by a digital algometer at several locations of 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.
2

Change in range of movement of the temporomandibular joint

Active and passive range of movement measured by a digital caliper.

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.
3

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).

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.
4

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).

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alcala

Lead sponsor

Source ClinicalTrials.gov
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