Myofascial Trigger PointsNCT03890393
A Clinical Observation on Electrophysiology in Headache Patients 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
Through an observational, cross-sectional study, muscle activity was compared among 21 subjects with episodic headache, 17 subjects with chronic headache and 17 age-matched healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Trigger Points
- What is being tested?
- Electromyography
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2018
- 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: All the patients were recruited from the headache clinic of Neurology in the first affiliated hospital of Nanjing Medical University from January/2018 to October/2018. Their diagnosis of headache were made according to the third edition of International Classification of Headache Disorders (ICHD-III).
Who may be able to join
- Have at least one onset of headache in the last week,
- Aged between 18-65 years,
- No special treatment or invasive test on pericranial muscles in the last month, and no painkillers or muscle relaxants in the last week.
Who cannot join
- History of surgery, trauma, tumor and spinal disease affecting the head and neck,
- Being unable to cooperate with inspection and questionnaires for any reason (severe systemic disease, bleeder, communication barriers and so on),
- People with definite mental disorders such as anxiety and depression.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
About this study
Official title: Muscle Activity of Pericranial Muscles in Patients With Episodic or Chronic Headache vs Asymptomatic Controls: a Cross-sectional Study
Through an observational, cross-sectional study, muscle activity was compared among 21 subjects with episodic headache, 17 subjects with chronic headache and 17 age-matched healthy controls. Muscle activity was bilaterally tested with needle electromyography at rest status, targeting at myofascial trigger points (MTrPs) in the frontal, temporal, sternocleidomastoid (SCM), splenius capitis, splenius cervicis and trapezius of each subject. Headache characteristics (intensity, frequency and duration), McGill Pain Questionnaire (MPQ) and Digital Span (DS) scales were secondary outcomes. The correlation between muscle activity and headache characteristics was also analyzed.
This study provides preliminary evidence of the relationship between muscle and the chronicity of headache.
- Conditions
- Myofascial Trigger Points
- Being tested
- Electromyography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectromyographyDevice
Muscle activity was bilaterally tested with needle electromyography at rest status, targeting at myofascial trigger points (MTrPs) in the frontal, temporal, sternocleidomastoid (SCM), splenius capitis, splenius cervicis and trapezius of each subject.
| Study group | Role | What they receive |
|---|---|---|
| patients with episodic headache | Not described Receives: Device: Electromyography | |
| patients with chronic headache | Not described Receives: Device: Electromyography | |
| healthy controls | Not described Receives: Device: Electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pericranial muscle activity
It was evaluated with EMG/EP equipment(9031A070 KEYPOINT Dantec) and the matching disposable needle electrode(Specification: 25mm*0.3mm, 30G) with a sampling frequency of 125 Hz and a measuring range of 0.2mv.The spontaneous electric activity of each pericranial muscle was recorded as 0 to 4 scores: 0 score= no repeatable spontaneous electric activity, 1 score=a single, repeatable string of spontaneous electric activity, 2 scores= obvious spontaneous electric activity in two or more areas of the muscle, 3 scores= obvious spontaneous electric activity in any area of the muscle, 4 scores= a lot of spontaneous electric activity over the whole record screen. The maximum scores of a participant was 48(6*2*4［insertion(frontal, temporal, sternocleidomastoid, splenius capitis, splenius cervicis and trapezius) *right or left* maximum scores of a muscle]).
Measured: On the day the participant was enrolled
Secondary outcomes (2)
Short Form of the McGill Pain Questionnaire(SF-MPQ)
This scale included three parts:Pain Rating Index (PRI), a 10cm-visual analogue scale(VAS) and Present Pain Intensity (PPI).PRI included 15 items to describe the characteristics of the pain(like nature and emotional problems) and each item was assessed with 0-3 scores.The higher scores respresented more serious condition.Total points of PRI was 0-15*3.VAS relefected their average intensity of the headache during the last month and was recorded as 0-10 scores according to the length.The higher scores respresented more serious average pain;PPI was recorded as 0-5 scores and the higher scores respresented more serious present pain(0 point=no pain;1 point=a little uncomfortable;2 points=uncomfortable;3 points=obvious headache;4 points=serious headache;5 points=unbearable headache).Total scores of SF-MPQ= PRI +VAS +PPI.
Measured: Immediately after the enrollment
Digital Span Test
Participants were requested to recite along and against two independent digits,seperately having 2-13 and 2-10 numbers.The highest number of the digits they recited was the score((2+2)-(13+10)) and the more scores they got, the wider memory they had.
Measured: Immediately after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Jan 2018
- Primary completion31 Oct 2018
- Study completion31 Dec 2018
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
- 55 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wan Qi, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890393
- Sponsor's protocol ID
- 2017-SR-037
- Status last verified
- Mar 2019
- First submitted
- 12 Feb 2019
- Last updated
- 26 Mar 2019
- 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 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Activity of Pericranial Muscles in Patients With Episodic or Chronic Headache vs Asymptomatic Controls: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03890393
- Acronym / sponsor ID
- 2017-SR-037
- Conditions
- Myofascial Trigger Points
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Mar 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.
Through an observational, cross-sectional study, muscle activity was compared among 21 subjects with episodic headache, 17 subjects with chronic headache and 17 age-matched healthy controls. Muscle activity was bilaterally tested with needle electromyography at rest status, targeting at myofascial trigger points (MTrPs) in the frontal, temporal, sternocleidomastoid (SCM), splenius capitis, splenius cervicis and trapezius of each subject. Headache characteristics (intensity, frequency and duration), McGill Pain Questionnaire (MPQ) and Digital Span (DS) scales were secondary outcomes. The correlation between muscle activity and headache characteristics was also analyzed.
This study provides preliminary evidence of the relationship between muscle and the chronicity of headache.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with episodic headache | – | Device: Electromyography |
| patients with chronic headache | – | Device: Electromyography |
| healthy controls | – | Device: Electromyography |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients were recruited from the headache clinic of Neurology in the first affiliated hospital of Nanjing Medical University from January/2018 to October/2018. Their diagnosis of headache were made according to the third edition of International Classification of Headache Disorders (ICHD-III).
Key inclusion criteria (3 listed)
- Have at least one onset of headache in the last week,
- Aged between 18-65 years,
- No special treatment or invasive test on pericranial muscles in the last month, and no painkillers or muscle relaxants in the last week.
Key exclusion criteria (3 listed)
- History of surgery, trauma, tumor and spinal disease affecting the head and neck,
- Being unable to cooperate with inspection and questionnaires for any reason (severe systemic disease, bleeder, communication barriers and so on),
- People with definite mental disorders such as anxiety and depression.
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 |
|---|---|---|
| ElectromyographyMuscle activity was bilaterally tested with needle electromyography at rest status, targeting at myofascial trigger points (MTrPs) in the frontal, temporal, sternocleidomastoid (SCM), splenius capitis, splenius cervicis and trapezius of each subject. | Device | healthy controls, patients with chronic headache, patients with episodic headache |
Primary outcome
Pericranial muscle activity
Time frame: On the day the participant was enrolled
It was evaluated with EMG/EP equipment(9031A070 KEYPOINT Dantec) and the matching disposable needle electrode(Specification: 25mm*0.3mm, 30G) with a sampling frequency of 125 Hz and a measuring range of 0.2mv.The spontaneous electric activity of each pericranial muscle was recorded as 0 to 4 scores: 0 score= no repeatable spontaneous electric activity, 1 score=a single, repeatable string of spontaneous electric activity, 2 scores= obvious spontaneous electric activity in two or more areas of the muscle, 3 scores= obvious spontaneous electric activity in any area of the muscle, 4 scores= a lot of spontaneous electric activity over the whole record screen. The maximum scores of a participant was 48(6*2*4［insertion(frontal, temporal, sternocleidomastoid, splenius capitis, splenius cervicis and trapezius) *right or left* maximum scores of a muscle]).
2 secondary outcomes
Short Form of the McGill Pain Questionnaire(SF-MPQ)
Time frame: Immediately after the enrollment
Digital Span Test
Time frame: Immediately after the enrollment
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 26 Mar 2019.
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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.
Wan Qi study chair
The First Affiliated Hospital with Nanjing Medical University
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 3 inclusion and 3 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 26 Mar 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 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?
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?
Pericranial muscle activity (time frame: On the day the participant was enrolled). 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 26 Mar 2019.