Myofascial Trigger PointsNCT03082547
A Clinical Observation on Neuropsychology and Electrophysiology in Headache Patinets With Myofascial Trigger Points
An observational study of Myofascial Trigger Points, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
To study the clinical characteristics of headache patients with pericranial myofascial trigger points(MTrPs),and to explore the possible pathogenesis of MTrPs,investigators hope to find the possible electrical biomarkers for clinical diagnosis and treatment, and to improve the effect of headache treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myofascial Trigger Points
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to 1 Dec 2017
- How long will I take part?
- 3 Months
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: To enroll headache patients with pericranial myofascial trigger points into the groups in our hospital outpatients and inpatients.
Who may be able to join
- Primary headache patients with pericranial myofascial trigger points.
Who cannot join
- Cranial weeks muscle infection or trauma, medical history, physical examination, laboratory and imaging studies suggest secondary headache patients except cervicalheadache.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The needle pole electromyography
Nanjing, Jiangsu, 210029
Zhaochun Shi, master, 13621590232, 185789282@qq.com
About this study
To study the clinical characteristics of headache patients with pericranial myofascial trigger points(MTrPs),and to explore the possible pathogenesis of MTrPs,investigators hope to find the possible electrical biomarkers for clinical diagnosis and treatment, and to improve the effect of headache treatment.
Read the detailed description
A series of neuropsychological test scale including Mini-mental State Examination(MMSE),Hamilton Anxiety Rating Scale(HAMA) and Hamilton Depression Rating Scale (HMAD) were evaluated among all patients.The needle pole electromyography (EMG) inspection were practiced on subjects with myofascial trigger points ,for analysing those electrophysiological characteristics.
- Conditions
- Myofascial Trigger Points
- Keywords
- Headache, Neuropsychological tests, Myofascial trigger points, electrophysiology
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Headache Groub | Headache patients with myofascial trigger points. | |
| Healthy Groub | No headache or other diseases can cause headaches of healthy people. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography
The needle pole electromyography (EMG) inspection
Measured: 30 minutes
Secondary outcomes (3)
Hamilton Anxiety Rating Scale(HAMA)
Evaluating Anxiety state: Total score without anxiety symptoms less than 7 ,> 7 points might be anxious, > 14 points must be anxious, > 21 points obvious anxiety, 29 > serious anxiety
Measured: 20 minutes
Mini-mental State Examination(MMSE)
Evaluating cognitive State, MMSE boundary between normal and abnormal value related to the degree of education, literacy (not education) group of 17 points or less, primary school (education duration of 6 years or less) group of 20 or less, secondary or above (education duration of > 6 years) group of 24 points or less, the following boundary value for cognitive function defect, above normal.
Measured: 20 minutes
Hamilton Depression Rating Scale (HMAD)
Evaluating depression state:Normal score < 8 points, 8 ~ 20 points might be depression, 20 ~ 35 must have depression, > 35 severe depression.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Aug 2016
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Trigger PointsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Wan, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082547
- Sponsor's protocol ID
- myofascial trigger points
- Status last verified
- Mar 2017
- First submitted
- 4 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Observation on Neuropsychology and Electrophysiology in Headache Patinets With Myofascial Trigger Points
- ClinicalTrials.gov ID
- NCT03082547
- Acronym / sponsor ID
- myofascial trigger points
- Conditions
- Myofascial Trigger Points
- Keywords
- Headache, Neuropsychological tests, Myofascial trigger points, electrophysiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 17 Mar 2017 (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.
To study the clinical characteristics of headache patients with pericranial myofascial trigger points(MTrPs),and to explore the possible pathogenesis of MTrPs,investigators hope to find the possible electrical biomarkers for clinical diagnosis and treatment, and to improve the effect of headache treatment.
Detailed description
A series of neuropsychological test scale including Mini-mental State Examination(MMSE),Hamilton Anxiety Rating Scale(HAMA) and Hamilton Depression Rating Scale (HMAD) were evaluated among all patients.The needle pole electromyography (EMG) inspection were practiced on subjects with myofascial trigger points ,for analysing those electrophysiological characteristics.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Headache Groub | – | –Headache patients with myofascial trigger points. |
| Healthy Groub | – | –No headache or other diseases can cause headaches of healthy people. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- To enroll headache patients with pericranial myofascial trigger points into the groups in our hospital outpatients and inpatients.
Key inclusion criteria (1 listed)
- Primary headache patients with pericranial myofascial trigger points.
Key exclusion criteria (1 listed)
- Cranial weeks muscle infection or trauma, medical history, physical examination, laboratory and imaging studies suggest secondary headache patients except cervicalheadache.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Electromyography
Time frame: 30 minutes
The needle pole electromyography (EMG) inspection
3 secondary outcomes
Hamilton Anxiety Rating Scale(HAMA)
Time frame: 20 minutes
Mini-mental State Examination(MMSE)
Time frame: 20 minutes
Hamilton Depression Rating Scale (HMAD)
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 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.
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 Trigger Points, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 1 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 17 Mar 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 China. 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 Qi Wan, professor (13770316989, qi_wan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (time frame: 30 minutes). 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 17 Mar 2017.