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

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.

Study Overview

• Status: Unknown
• Conditions: Myofascial Trigger Points

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The needle pole electromyography
      • Contact: Zhaochun Shi, master; Phone Number: 13621590232; Email: 185789282@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Headache Groub; Headache patients with myofascial trigger points.
Healthy Groub; No headache or other diseases can cause headaches of healthy people.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyography	The needle pole electromyography (EMG) inspection	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Anxiety Rating Scale(HAMA)	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	20 minutes
Mini-mental State Examination(MMSE)	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.	20 minutes
Hamilton Depression Rating Scale (HMAD)	Evaluating depression state:Normal score < 8 points, 8 ~ 20 points might be depression, 20 ~ 35 must have depression, > 35 severe depression.	20 minutes

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 4, 2017
• First Submitted That Met QC Criteria: March 12, 2017
• First Posted (Actual): March 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 12, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Headache; electrophysiology; Myofascial trigger points; Neuropsychological tests
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: myofascial trigger points

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No