Back to resultsIntraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders
Primary Purpose
Temporomandibular Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intraoral manual therapy
Extraoral manual therapy
Exercise and counselling
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorder
Eligibility Criteria
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.
Sites / Locations
- University of AlcaláRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Intraoral Manual Therapy plus exercise and education.
Extraoral Manual Therapy plus exercise and education.
Exercise and education.
Arm Description
Six sessions of intraoral manual therapy plus exercise and counselling.
Six sessions of extraoral manual therapy plus exercise and counselling.
Exercise and counselling alone without any manual therapy treatment.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change in pain pressure threshold
Pain pressure threshold measured by a digital algometer at several locations of temporomandibular joint.
Change in range of movement of the temporomandibular joint
Active and passive range of movement measured by a digital caliper.
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).
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).
Change in anxiety
Anxiety measured with State-Trait Anxiety Inventory (STAI). STAI ranges from 20 (lower anxiety) to 80 (greater anxiety).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05167656
Brief Title
Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders
Official Title
Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intraoral Manual Therapy plus exercise and education.
Arm Type
Experimental
Arm Description
Six sessions of intraoral manual therapy plus exercise and counselling.
Arm Title
Extraoral Manual Therapy plus exercise and education.
Arm Type
Experimental
Arm Description
Six sessions of extraoral manual therapy plus exercise and counselling.
Arm Title
Exercise and education.
Arm Type
Active Comparator
Arm Description
Exercise and counselling alone without any manual therapy treatment.
Intervention Type
Other
Intervention Name(s)
Intraoral manual therapy
Intervention Description
Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.
Intervention Type
Other
Intervention Name(s)
Extraoral manual therapy
Intervention Description
Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.
Intervention Type
Other
Intervention Name(s)
Exercise and counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain intensity
Description
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 Outcome Measure Information:
Title
Change in pain pressure threshold
Description
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.
Title
Change in range of movement of the temporomandibular joint
Description
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.
Title
Change in quality of life
Description
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.
Title
Change in disability
Description
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.
Title
Change in anxiety
Description
Anxiety measured with State-Trait Anxiety Inventory (STAI). STAI ranges from 20 (lower anxiety) to 80 (greater anxiety).
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Ballesteros Frutos, PhD student
Phone
638332255
Email
jorgeballes10@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Ballesteros Frutos
Phone
+34 638 33 22 55
Email
jorgeballes10@gmail.com
Facility Information:
Facility Name
University of Alcalá
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Ballesteros, PhD Student
Phone
638332255
Email
jorgeballes10@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders
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