NCT03082547

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

March 4, 2017

Last Update Submit

March 12, 2017

Conditions

Myofascial Trigger Points

Keywords

HeadacheNeuropsychological testsMyofascial trigger pointselectrophysiology

Outcome Measures

Primary Outcomes (1)

  • Electromyography

    The needle pole electromyography (EMG) inspection

    30 minutes

Secondary Outcomes (3)

  • Hamilton Anxiety Rating Scale(HAMA)

    20 minutes

  • Mini-mental State Examination(MMSE)

    20 minutes

  • Hamilton Depression Rating Scale (HMAD)

    20 minutes

Study Arms (2)

Headache Groub

Headache patients with myofascial trigger points.

Healthy Groub

No headache or other diseases can cause headaches of healthy people.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Primary headache patients with pericranial myofascial trigger points.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The needle pole electromyography

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Qi Wan, professor

CONTACT

13770316989qi_wan@126.com

Xue Zhang, master

CONTACT

18360866176qxzhangxue@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

March 4, 2017

First Posted

March 17, 2017

Study Start

August 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 17, 2017

Record last verified: 2017-03

Locations

CN(1)