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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03082547
Other study ID # myofascial trigger points
Secondary ID
Status Recruiting
Phase N/A
First received March 4, 2017
Last updated March 12, 2017
Start date August 1, 2016
Est. completion date December 1, 2017

Study information

Verified date March 2017
Source The First Affiliated Hospital with Nanjing Medical University
Contact Qi Wan, professor
Phone 13770316989
Email qi_wan@126.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2017
Est. primary completion date December 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The needle pole electromyography Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Electromyography The needle pole electromyography (EMG) inspection 30 minutes
Secondary 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
Secondary 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
Secondary 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
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Completed NCT03890393 - A Clinical Observation on Electrophysiology in Headache Patients With Myofascial Trigger Points