A Clinical Observation on Neuropsychology and Electrophys... | NCT03082547

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

NCT03082547

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Status

Unknown status

Last Update Posted

Mar 17, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Myofascial Trigger Points

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2016Actual

Primary Completion Date

Dec 1, 2017Estimated

Completion Date

Dec 1, 2017Estimated

First Submitted Date

Mar 4, 2017

First Submission Date that Met QC Criteria

Mar 12, 2017

First Posted Date

Mar 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2017

Last Update Posted Date

Mar 17, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Qi Wan, chief physician, The First Affiliated Hospital with Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital with Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Headache Groub		Headache patients with myofascial trigger points.
Healthy Groub		No headache or other diseases can cause headaches of healthy people.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

To enroll headache patients with pericranial myofascial trigger points into the groups in our hospital outpatients and inpatients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qi Wan, professor	Contact	13770316989		qi_wan@126.com
Xue Zhang, master	Contact	18360866176		qxzhangxue@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The needle pole electromyography	Recruiting	Nanjing	Jiangsu	210029	China

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided