Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders

Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders. A Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Disorder
• Intervention / Treatment: Other: Intraoral manual therapy; Other: Exercise and counselling; Other: Extraoral manual therapy

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge Ballesteros Frutos, PhD student; Phone Number: 638332255; Email: jorgeballes10@gmail.com
• Study Contact Backup: Name: Jorge Ballesteros Frutos; Phone Number: +34 638 33 22 55; Email: jorgeballes10@gmail.com

Study Locations

• Spain
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28805
      • Recruiting
      • University of Alcala
      • Contact: Jorge Ballesteros, PhD Student; Phone Number: 638332255; Email: jorgeballes10@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoral Manual Therapy plus exercise and education.; Six sessions of intraoral manual therapy plus exercise and counselling.	Other: Intraoral manual therapy; Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.; Other: Exercise 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.
Experimental: Extraoral Manual Therapy plus exercise and education.; Six sessions of extraoral manual therapy plus exercise and counselling.	Other: Exercise 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.; Other: Extraoral manual therapy; Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.
Active Comparator: Exercise and education.; Exercise and counselling alone without any manual therapy treatment.	Other: Exercise 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain pressure threshold	Pain pressure threshold measured by a digital algometer at several locations of 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.
Change in range of movement of the temporomandibular joint	Active and passive range of movement measured by a digital caliper.	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.
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).	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.
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).	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.
Change in anxiety	Anxiety measured with State-Trait Anxiety Inventory (STAI). STAI ranges from 20 (lower anxiety) to 80 (greater 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.

Collaborators and Investigators

• Sponsor: University of Alcala

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: CEID/2021/4/087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No