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

Intervention / Treatment

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

  • Spain
      • Zaragoza, Spain
        • Universidad San Jorge

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.
Other: Manual therapy

6 treatments: 2 treatments for week

1 treatment = 30 minutes

Other: Home physical therapy
once a day: 15 minutes
Active Comparator: CONTROL
Manual therapy in cervical region Home physical therapy in cervical region
Other: Manual therapy in cervical region

6 treatments: 2 treatments for week

1 treatment = 30 minutes

Other: Home physical therapy in cervical region
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
Pittsburgh Sleep Quality Index
3 months
Pain threshold pressure
Time Frame: 3 months
Pressure algometer in masticatory muscle (area trigeminal) and control point in area extra-trigeminal
3 months
Pain catastrophizing scale (PCS)
Time Frame: 3 months
3 months
Craniofacial Pain and Disability Inventory (CF-PDI)
Time Frame: 3 months
3 months
Tampa scale of Kinesiophobia (TSK)
Time Frame: 3 months
3 months
Tampa scale of Kinesiophobia of cranio-mandibular disorder (TSK-TCM)
Time Frame: 3 months
3 months
Maximal Mouth Opening pain free
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Collaborators

Hospital Miguel Servet

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

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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