Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders

Not Applicable

Recruiting

• Conditions: Temporomandibular Disorder

• 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

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