Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders

Not Applicable

Recruiting

• Conditions: Temporomandibular Disorder
• Interventions: Other: Intraoral manual therapy; Other: Exercise and counselling; Other: Extraoral manual therapy

• Registration Number: NCT05167656
• Lead Sponsor: University of Alcala

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-22
• Study Start: 2022-04-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2026-09
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraoral Manual Therapy plus exercise and education.	Intraoral manual therapy	Six sessions of intraoral manual therapy plus exercise and counselling.
Exercise and education.	Exercise and counselling	Exercise and counselling alone without any manual therapy treatment.
Extraoral Manual Therapy plus exercise and education.	Extraoral manual therapy	Six sessions of extraoral manual therapy plus exercise and counselling.
Intraoral Manual Therapy plus exercise and education.	Exercise and counselling	Six sessions of intraoral manual therapy plus exercise and counselling.
Extraoral Manual Therapy plus exercise and education.	Exercise and counselling	Six sessions of extraoral manual therapy plus exercise and counselling.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

University of Alcalá; 🇪🇸 Alcalá De Henares, Madrid, Spain