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Completed

NCT Number: NCT03890393

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Electromyography

Device

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.

Primary outcomes

  1. 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]).

Secondary outcomes

  1. Short Form of the McGill Pain Questionnaire(SF-MPQ)

    Time frame: Immediately after the enrollment

    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.

  2. Digital Span Test

    Time frame: Immediately after the enrollment

    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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Muscle Activity of Pericranial Muscles in Patients With Episodic or Chronic Headache vs Asymptomatic Controls: a Cross-sectional Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2019
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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