Back to resultsEffect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders
Primary Purpose
Chronic Migraine, Temporomandibular Disorders
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual therapy
Home physical therapy
Manual therapy in cervical region
Home physical therapy in cervical region
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Migraine focused on measuring Chronic Migraine, Temporomandibular Disorders, Physical Therapy, Manual Therapy, Home physical Therapy
Eligibility Criteria
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
Sites / Locations
- Universidad San Jorge
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
INTERVENTION
CONTROL
Arm Description
Manual Therapy in temporomandibular joint and cervical region. Home physical therapy in temporomandibular joint and cervical region.
Manual therapy in cervical region Home physical therapy in cervical region
Outcomes
Primary Outcome Measures
Headache Impact Test (HIT-6)
Secondary Outcome Measures
Visual Analogue Scale (VAS)
Quality of life (SF-36)
Sleep Quality
Pittsburgh Sleep Quality Index
Pain threshold pressure
Pressure algometer in masticatory muscle (area trigeminal) and control point in area extra-trigeminal
Pain catastrophizing scale (PCS)
Craniofacial Pain and Disability Inventory (CF-PDI)
Tampa scale of Kinesiophobia (TSK)
Tampa scale of Kinesiophobia of cranio-mandibular disorder (TSK-TCM)
Maximal Mouth Opening pain free
Full Information
NCT ID
NCT02627014
First Posted
December 4, 2015
Last Updated
August 7, 2017
Sponsor
Cardenal Herrera University
Collaborators
Hospital Miguel Servet
1. Study Identification
Unique Protocol Identification Number
NCT02627014
Brief Title
Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders
Official Title
Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
Collaborators
Hospital Miguel Servet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Temporomandibular Disorders
Keywords
Chronic Migraine, Temporomandibular Disorders, Physical Therapy, Manual Therapy, Home physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INTERVENTION
Arm Type
Experimental
Arm Description
Manual Therapy in temporomandibular joint and cervical region. Home physical therapy in temporomandibular joint and cervical region.
Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
Manual therapy in cervical region Home physical therapy in cervical region
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
6 treatments: 2 treatments for week
1 treatment = 30 minutes
Intervention Type
Other
Intervention Name(s)
Home physical therapy
Intervention Description
once a day: 15 minutes
Intervention Type
Other
Intervention Name(s)
Manual therapy in cervical region
Intervention Description
6 treatments: 2 treatments for week
1 treatment = 30 minutes
Intervention Type
Other
Intervention Name(s)
Home physical therapy in cervical region
Intervention Description
once a day: 15 minutes
Primary Outcome Measure Information:
Title
Headache Impact Test (HIT-6)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Time Frame
3 months
Title
Quality of life (SF-36)
Time Frame
3 months
Title
Sleep Quality
Description
Pittsburgh Sleep Quality Index
Time Frame
3 months
Title
Pain threshold pressure
Description
Pressure algometer in masticatory muscle (area trigeminal) and control point in area extra-trigeminal
Time Frame
3 months
Title
Pain catastrophizing scale (PCS)
Time Frame
3 months
Title
Craniofacial Pain and Disability Inventory (CF-PDI)
Time Frame
3 months
Title
Tampa scale of Kinesiophobia (TSK)
Time Frame
3 months
Title
Tampa scale of Kinesiophobia of cranio-mandibular disorder (TSK-TCM)
Time Frame
3 months
Title
Maximal Mouth Opening pain free
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Garrigós
Organizational Affiliation
Universidad San Jorge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad San Jorge
City
Zaragoza
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders
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