Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders

Chronic Migraine Clinical Trial

Official title:

Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627014
• Other study ID #: CM_TMD_1
• Status: Completed
• Phase: N/A
• First received: December 4, 2015
• Last updated: August 7, 2017
• Start date: July 2015
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Migraine
• Disease
• Migraine Disorders
• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• Manual therapy
6 treatments: 2 treatments for week 1 treatment = 30 minutes
• Home physical therapy
once a day: 15 minutes
• Manual therapy in cervical region
6 treatments: 2 treatments for week 1 treatment = 30 minutes
• Home physical therapy in cervical region
once a day: 15 minutes

Locations

Country	Name	City	State
Spain	Universidad San Jorge	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Cardenal Herrera University	Hospital Miguel Servet

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Impact Test (HIT-6)		3 months
Secondary	Visual Analogue Scale (VAS)		3 months
Secondary	Quality of life (SF-36)		3 months
Secondary	Sleep Quality	Pittsburgh Sleep Quality Index	3 months
Secondary	Pain threshold pressure	Pressure algometer in masticatory muscle (area trigeminal) and control point in area extra-trigeminal	3 months
Secondary	Pain catastrophizing scale (PCS)		3 months
Secondary	Craniofacial Pain and Disability Inventory (CF-PDI)		3 months
Secondary	Tampa scale of Kinesiophobia (TSK)		3 months
Secondary	Tampa scale of Kinesiophobia of cranio-mandibular disorder (TSK-TCM)		3 months
Secondary	Maximal Mouth Opening pain free		3 months