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A Clinical Observation on Neuropsychology and Electrophysiology in Headache Patinets With Myofascial Trigger Points

This study is currently recruiting participants.
Verified March 2017 by Qi Wan, The First Affiliated Hospital with Nanjing Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03082547
First Posted: March 17, 2017
Last Update Posted: March 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Qi Wan, The First Affiliated Hospital with Nanjing Medical University
  Purpose
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.

Condition
Myofascial Trigger Points

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Months
Official Title: A Clinical Observation on Neuropsychology and Electrophysiology in Headache Patinets With Myofascial Trigger Points

Resource links provided by NLM:


Further study details as provided by Qi Wan, The First Affiliated Hospital with Nanjing Medical University:

Primary Outcome Measures:
  • Electromyography [ Time Frame: 30 minutes ]
    The needle pole electromyography (EMG) inspection


Secondary Outcome Measures:
  • Hamilton Anxiety Rating Scale(HAMA) [ Time Frame: 20 minutes ]
    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

  • Mini-mental State Examination(MMSE) [ Time Frame: 20 minutes ]
    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.

  • Hamilton Depression Rating Scale (HMAD) [ Time Frame: 20 minutes ]
    Evaluating depression state:Normal score < 8 points, 8 ~ 20 points might be depression, 20 ~ 35 must have depression, > 35 severe depression.


Estimated Enrollment: 100
Actual Study Start Date: August 1, 2016
Estimated Study Completion Date: December 1, 2017
Estimated Primary Completion Date: December 1, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Headache Groub
Headache patients with myofascial trigger points.
Healthy Groub
No headache or other diseases can cause headaches of healthy people.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
To enroll headache patients with pericranial myofascial trigger points into the groups in our hospital outpatients and inpatients.
Criteria

Inclusion Criteria:

  • Primary headache patients with pericranial myofascial trigger points.

Exclusion Criteria:

  • Cranial weeks muscle infection or trauma, medical history, physical examination, laboratory and imaging studies suggest secondary headache patients except cervicalheadache.
  Contacts and Locations
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): NCT03082547


Contacts
Contact: Qi Wan, professor 13770316989 qi_wan@126.com
Contact: Xue Zhang, master 18360866176 qxzhangxue@126.com

Locations
China, Jiangsu
The needle pole electromyography Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Zhaochun Shi, master    13621590232    185789282@qq.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
  More Information

Responsible Party: Qi Wan, chief physician, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03082547     History of Changes
Other Study ID Numbers: myofascial trigger points
First Submitted: March 4, 2017
First Posted: March 17, 2017
Last Update Posted: March 17, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Qi Wan, The First Affiliated Hospital with Nanjing Medical University:
Headache
Neuropsychological tests
Myofascial trigger points
electrophysiology

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms