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

Sponsor

Cardenal Herrera University (Other)

Overall Status

Completed

CT.gov ID

NCT02627014

Collaborator

Hospital Miguel Servet (Other)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Migraine Temporomandibular Disorders	Other: Manual therapy Other: Home physical therapy Other: Manual therapy in cervical region Other: Home physical therapy in cervical region	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Headache Impact Test (HIT-6) [3 months]

Secondary Outcome Measures

Visual Analogue Scale (VAS) [3 months]
Quality of life (SF-36) [3 months]
Sleep Quality [3 months]
Pittsburgh Sleep Quality Index
Pain threshold pressure [3 months]
Pressure algometer in masticatory muscle (area trigeminal) and control point in area extra-trigeminal
Pain catastrophizing scale (PCS) [3 months]
Craniofacial Pain and Disability Inventory (CF-PDI) [3 months]
Tampa scale of Kinesiophobia (TSK) [3 months]
Tampa scale of Kinesiophobia of cranio-mandibular disorder (TSK-TCM) [3 months]
Maximal Mouth Opening pain free [3 months]