Overview

This trial is active, not recruiting.

Conditions chronic migraine, temporomandibular disorders
Treatments manual therapy, home physical therapy, manual therapy in cervical region, home physical therapy in cervical region
Sponsor Cardenal Herrera University
Collaborator Hospital Miguel Servet
Start date July 2015
End date January 2017
Trial size 45 participants
Trial identifier NCT02627014, CM_TMD_1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Manual Therapy in temporomandibular joint and cervical region. Home physical therapy in temporomandibular joint and cervical region.
manual therapy
6 treatments: 2 treatments for week 1 treatment = 30 minutes
home physical therapy
once a day: 15 minutes
(Active Comparator)
Manual therapy in cervical region Home physical therapy in cervical region
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

Primary Outcomes

Measure
Headache Impact Test (HIT-6)
time frame: 3 months

Secondary Outcomes

Measure
Visual Analogue Scale (VAS)
time frame: 3 months
Quality of life (SF-36)
time frame: 3 months
Sleep Quality
time frame: 3 months
Pain threshold pressure
time frame: 3 months
Pain catastrophizing scale (PCS)
time frame: 3 months
Craniofacial Pain and Disability Inventory (CF-PDI)
time frame: 3 months
Tampa scale of Kinesiophobia (TSK)
time frame: 3 months
Tampa scale of Kinesiophobia of cranio-mandibular disorder (TSK-TCM)
time frame: 3 months
Maximal Mouth Opening pain free
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders
Principal investigator Miriam Garrigós
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Cardenal Herrera University.