Myofascial PainNCT03962556
Distribution of Trigger Points in Patient Who Have Myofascial Pain Disorder
An observational study of Myofascial Pain, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Myofascial pain alone covers 45.3% of the diagnosis of TMJ. It is defined as palpation sensitivity and regional muscle pain. Clinically muscle pain connects to myofascial trigger points.These trigger points are hypersensitive points located in a tense band of the skeletal muscle, which can be described, causing… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain
- What is being tested?
- bimanual palpation
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2018to 15 Apr 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Will be conducted in volunteers who applied to our clinic with complaint of TMJ
Who may be able to join
- Will be conducted in volunteers who applied to our clinic with complaint of TMJ
Who cannot join
- Diagnosed rheumatoid diseases and fibromyalgia.
- Psychiatric drug users.
- Patients who use muscle relaxants.
- TME pathology
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Necmettin Erbakan University/Dentistry Faculty
Konya
Kubilay Işık
About this study
Myofascial pain alone covers 45.3% of the diagnosis of TMJ. It is defined as palpation sensitivity and regional muscle pain. Clinically muscle pain connects to myofascial trigger points.These trigger points are hypersensitive points located in a tense band of the skeletal muscle, which can be described, causing provoked or spontaneous pain. They are divided into two as active and latent. Those who cause spontaneous pain are active, and those who provoke pain are considered latent.Spasm in the chewing muscles with myofascial pain reduces the patient's pain threshold and quality of life.
Therefore, patients with spasm and TMJ pain in the masticatory muscles should be examined for head and neck muscles, the presence of myofascial trigger points should be determined and the head and neck muscles should be included in physical therapy.
The aim of this study was to determine the presence of myofascial trigger points in patients presenting with pain in the masticatory muscles and TMJ region, and to determine the relationship between the presence of trigger point and the degree of pain.
- Conditions
- Myofascial Pain
- Being tested
- bimanual palpation
- Keywords
- trigger point,myofacial pain
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimanual palpationOther
bimanual palpation....i..
| Study group | Role | What they receive |
|---|---|---|
| Non-Trigger Point | Not described Receives: Other: bimanual palpation | |
| Trigger Point | Not described Receives: Other: bimanual palpation |
What is being measured
The primary outcome is the main question the study is designed to answer.
masticatory and cervical muscles examination for determining trigger points
detecting the trigger point (yes or no), determining the number of trigger points and determining the region on the muscle
Measured: first day visit
visual analog scale for pain (VAS)
scale to find pain amount , pain scores from 0 to 10 will be taken from patients and higher scores indicate worse pain,all of patient's mean pain score to be determined.
Measured: first day visit
Secondary outcomes (1)
prevalence of trigger points in facial pain disorder patients
to compare pain scores of patients with and without trigger point,the distribution of trigger points on the masticatory and cervical muscles
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start15 Dec 2018
- Primary completion15 Jan 2020 (estimated)
- Study completion15 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Bastürk, Necmettin Erbakan University
- Investigators
- Kubilay Işık, Study chair, Necmettin Erbakan University/Dentistry FacultyDilek Menziletoğlu, Study director, Necmettin Erbakan University/Dentistry FacultyFunda Basturk, Principal investigator, Necmettin Erbakan University/Dentistry Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962556
- Sponsor's protocol ID
- NecmettinEU1
- Status last verified
- Aug 2019
- First submitted
- 19 Feb 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Trigger Points in Patient Who Have Myofascial Pain Disorder
- ClinicalTrials.gov ID
- NCT03962556
- Acronym / sponsor ID
- NecmettinEU1
- Conditions
- Myofascial Pain
- Keywords
- trigger point,myofacial pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 15 Jan 2020 (estimated)
- Study completion
- 15 Apr 2020 (estimated)
- First posted
- 24 May 2019 (actual)
- 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.
Myofascial pain alone covers 45.3% of the diagnosis of TMJ. It is defined as palpation sensitivity and regional muscle pain. Clinically muscle pain connects to myofascial trigger points.These trigger points are hypersensitive points located in a tense band of the skeletal muscle, which can be described, causing provoked or spontaneous pain. They are divided into two as active and latent. Those who cause spontaneous pain are active, and those who provoke pain are considered latent.Spasm in the chewing muscles with myofascial pain reduces the patient's pain threshold and quality of life.
Therefore, patients with spasm and TMJ pain in the masticatory muscles should be examined for head and neck muscles, the presence of myofascial trigger points should be determined and the head and neck muscles should be included in physical therapy.
The aim of this study was to determine the presence of myofascial trigger points in patients presenting with pain in the masticatory muscles and TMJ region, and to determine the relationship between the presence of trigger point and the degree of pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Trigger Point | – | Other: bimanual palpation |
| Trigger Point | – | Other: bimanual palpation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Will be conducted in volunteers who applied to our clinic with complaint of TMJ
Key inclusion criteria (1 listed)
- Will be conducted in volunteers who applied to our clinic with complaint of TMJ
Key exclusion criteria (4 listed)
- Diagnosed rheumatoid diseases and fibromyalgia.
- Psychiatric drug users.
- Patients who use muscle relaxants.
- TME pathology
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 |
|---|---|---|
| bimanual palpationbimanual palpation....i.. | Other | Non-Trigger Point, Trigger Point |
Primary outcome
masticatory and cervical muscles examination for determining trigger points
Time frame: first day visit
detecting the trigger point (yes or no), determining the number of trigger points and determining the region on the muscle
visual analog scale for pain (VAS)
Time frame: first day visit
scale to find pain amount , pain scores from 0 to 10 will be taken from patients and higher scores indicate worse pain,all of patient's mean pain score to be determined.
1 secondary outcome
prevalence of trigger points in facial pain disorder patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Myofascial Pain
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Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
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Effects of Myofascial Techniques on Chronic Low Back Pain
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Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
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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.
Kubilay Işık study chair
Necmettin Erbakan University/Dentistry Faculty
Dilek Menziletoğlu study director
Necmettin Erbakan University/Dentistry Faculty
Funda Basturk principal investigator
Necmettin Erbakan University/Dentistry Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myofascial Pain, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Aug 2019. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Funda Basturk (+905531906023, dtfunda.basturk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
masticatory and cervical muscles examination for determining trigger points (time frame: first day visit). The study lists 2 primary outcomes in all. 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 20 Aug 2019.