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CompletedNCT03890393Updated Mar 26, 2019

A Clinical Observation on Electrophysiology in Headache Patients With Myofascial Trigger Points

An observational study in Myofascial Trigger Points, sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-26.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
55
Ages
18 Years to 65 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Myofascial Trigger Points

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In context

Headache

1,226 studies on the registry are indexed under Headache; 202 are open to participants now.

This study's enrollment of 55 is below the median of 120 across 257 observational studies indexed under Headache.

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Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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).

Inclusion criteria

  1. Have at least one onset of headache in the last week,
  2. Aged between 18-65 years,
  3. No special treatment or invasive test on pericranial muscles in the last month, and no painkillers or muscle relaxants in the last week.

Exclusion criteria

Exclusion Criteria:

  1. History of surgery, trauma, tumor and spinal disease affecting the head and neck,
  2. Being unable to cooperate with inspection and questionnaires for any reason (severe systemic disease, bleeder, communication barriers and so on),
  3. People with definite mental disorders such as anxiety and depression.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
55 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with episodic headache

    Device: Electromyography

  • patients with chronic headache

    Device: Electromyography

  • healthy controls

    Device: Electromyography

Interventions

  • DeviceElectromyography

    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.

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What researchers measure

Primary outcomes

  1. 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\]).

    Time frame: On the day the participant was enrolled

Secondary outcomes

  1. 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.

    Time frame: Immediately after the enrollment

  2. 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.

    Time frame: Immediately after the enrollment

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Study locations

1 site
  • The First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210000, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03890393
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Mar 26, 2019
Start date
Jan 1, 2018
Primary completion
Oct 31, 2018
Completion
Dec 31, 2018
Last update
Mar 26, 2019

Study contacts

Wan Qi
study chair · The First Affiliated Hospital with Nanjing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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