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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890393
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Brief 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.


Condition or disease Intervention/treatment
Myofascial Trigger Points Device: Electromyography

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Muscle Activity of Pericranial Muscles in Patients With Episodic or Chronic Headache vs Asymptomatic Controls: a Cross-sectional Study
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Group/Cohort Intervention/treatment
patients with episodic headache Device: Electromyography
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.

patients with chronic headache Device: Electromyography
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.

healthy controls Device: Electromyography
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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).
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890393


Locations
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China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Study Chair: Wan Qi The First Affiliated Hospital with Nanjing Medical University
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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03890393    
Other Study ID Numbers: 2017-SR-037
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations