Chronic MigraineNCT02627014
Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders
A study testing Manual therapy, Home physical therapy and Manual therapy in cervical region in people with Chronic Migraine and Temporomandibular Disorders, run by Cardenal Herrera University at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine, Temporomandibular Disorders
- What is being tested?
- Manual therapy, Home physical therapy and Manual therapy in cervical region
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic migraine (ICHD_III beta, 2013)
- Temporomandibular disorders (RDC/TMD)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Migraine, Temporomandibular Disorders
- Being tested
- Manual therapy, Home physical therapy, Manual therapy in cervical region, Home physical therapy in cervical region
- Keywords
- Chronic Migraine, Temporomandibular Disorders, Physical Therapy, Manual Therapy, Home physical Therapy
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
6 treatments: 2 treatments for week
1 treatment = 30 minutes
Home physical therapyOther
once a day: 15 minutes
Manual therapy in cervical regionOther
6 treatments: 2 treatments for week
1 treatment = 30 minutes
Home physical therapy in cervical regionOther
once a day: 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION | Experimental | Manual Therapy in temporomandibular joint and cervical region. Home physical therapy in temporomandibular joint and cervical region. Receives: Other: Manual therapy; Other: Home physical therapy |
| CONTROL | Active comparator | Manual therapy in cervical region Home physical therapy in cervical region Receives: Other: Manual therapy in cervical region; Other: Home physical therapy in cervical region |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Impact Test (HIT-6)
Measured: 3 months
Secondary outcomes (9)
Visual Analogue Scale (VAS)
Measured: 3 months
Quality of life (SF-36)
Measured: 3 months
Sleep Quality
Pittsburgh Sleep Quality Index
Measured: 3 months
Pain threshold pressure
Pressure algometer in masticatory muscle (area trigeminal) and control point in area extra-trigeminal
Measured: 3 months
Pain catastrophizing scale (PCS)
Measured: 3 months
Craniofacial Pain and Disability Inventory (CF-PDI)
Measured: 3 months
Tampa scale of Kinesiophobia (TSK)
Measured: 3 months
Tampa scale of Kinesiophobia of cranio-mandibular disorder (TSK-TCM)
Measured: 3 months
Maximal Mouth Opening pain free
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Miguel Servet
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Miriam Garrigós, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627014
- Sponsor's protocol ID
- CM_TMD_1
- Status last verified
- Aug 2017
- First submitted
- 4 Dec 2015
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment of Temporomandibular Joint in Patients With Chronic Migraine and Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT02627014
- Acronym / sponsor ID
- CM_TMD_1
- Conditions
- Chronic Migraine, Temporomandibular Disorders
- Keywords
- Chronic Migraine, Temporomandibular Disorders, Physical Therapy, Manual Therapy, Home physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Hospital Miguel Servet
- Study start
- Jul 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION | Experimental | Other: Manual therapy, Other: Home physical therapyManual Therapy in temporomandibular joint and cervical region. Home physical therapy in temporomandibular joint and cervical region. |
| CONTROL | Active comparator | Other: Manual therapy in cervical region, Other: Home physical therapy in cervical regionManual therapy in cervical region Home physical therapy in cervical region |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic migraine (ICHD_III beta, 2013)
- Temporomandibular disorders (RDC/TMD)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapy6 treatments: 2 treatments for week 1 treatment = 30 minutes | Other | INTERVENTION |
| Home physical therapyonce a day: 15 minutes | Other | INTERVENTION |
| Manual therapy in cervical region6 treatments: 2 treatments for week 1 treatment = 30 minutes | Other | CONTROL |
| Home physical therapy in cervical regiononce a day: 15 minutes | Other | CONTROL |
Primary outcome
Headache Impact Test (HIT-6)
Time frame: 3 months
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Garrigós principal investigator
Universidad San Jorge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy, Home physical therapy and Manual therapy in cervical region in people with Chronic Migraine and Temporomandibular Disorders, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Impact Test (HIT-6) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.