- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02627014
Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders
August 7, 2017 updated by: Eva Segura Ortí, Cardenal Herrera University
The aim of this study is to determine whether treatment of temporomandibular joint is more effective than usual care in patients with chronic migraine and temporomandibular disorders to reduce pain.
Study Overview
Status
Completed
Conditions
Detailed Description
The aim of this study is to determine whether treatment of temporomandibular joint added to the control group treatment and drug therapy patient base is more effective than just using the control group treatment and drug therapy in patients with chronic migraine and temporomandibular disorders to reduce pain and improve the quality of life related to health of patients.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zaragoza, Spain
- Universidad San Jorge
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic migraine (ICHD_III beta, 2013)
- Temporomandibular disorders (RDC/TMD)
Exclusion Criteria:
- other neurological disease
- psychiatric diseases
- Physical therapy treatment in the last 6 months
- dental treatment in the last 6 months
- surgery or trauma in the orofacial region
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: INTERVENTION
Manual Therapy in temporomandibular joint and cervical region.
Home physical therapy in temporomandibular joint and cervical region.
|
6 treatments: 2 treatments for week 1 treatment = 30 minutes
once a day: 15 minutes
|
Active Comparator: CONTROL
Manual therapy in cervical region Home physical therapy in cervical region
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6 treatments: 2 treatments for week 1 treatment = 30 minutes
once a day: 15 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Headache Impact Test (HIT-6)
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: 3 months
|
3 months
|
|
Quality of life (SF-36)
Time Frame: 3 months
|
3 months
|
|
Sleep Quality
Time Frame: 3 months
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Pittsburgh Sleep Quality Index
|
3 months
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Pain threshold pressure
Time Frame: 3 months
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Pressure algometer in masticatory muscle (area trigeminal) and control point in area extra-trigeminal
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3 months
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Pain catastrophizing scale (PCS)
Time Frame: 3 months
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3 months
|
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Craniofacial Pain and Disability Inventory (CF-PDI)
Time Frame: 3 months
|
3 months
|
|
Tampa scale of Kinesiophobia (TSK)
Time Frame: 3 months
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3 months
|
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Tampa scale of Kinesiophobia of cranio-mandibular disorder (TSK-TCM)
Time Frame: 3 months
|
3 months
|
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Maximal Mouth Opening pain free
Time Frame: 3 months
|
3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Miriam Garrigós, Universidad San Jorge
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
December 4, 2015
First Submitted That Met QC Criteria
December 9, 2015
First Posted (Estimate)
December 10, 2015
Study Record Updates
Last Update Posted (Actual)
August 8, 2017
Last Update Submitted That Met QC Criteria
August 7, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Headache Disorders, Primary
- Headache Disorders
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Disease
- Migraine Disorders
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
Other Study ID Numbers
- CM_TMD_1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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