A Clinical Observation on Electrophysiology in Headache Patients With Myofascial Trigger Points

NCT03890393 | Completed

• 1 other identifier: 2017-SR-037
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Through an observational, cross-sectional study, muscle activity was compared among 21 subjects with episodic headache, 17 subjects with chronic headache and 17 age-matched healthy controls. Muscle activity was bilaterally tested with needle electromyography at rest status, targeting at myofascial trigger points (MTrPs) in the frontal, temporal, sternocleidomastoid (SCM), splenius capitis, splenius cervicis and trapezius of each subject. Headache characteristics (intensity, frequency and duration), McGill Pain Questionnaire (MPQ) and Digital Span (DS) scales were secondary outcomes. The correlation between muscle activity and headache characteristics was also analyzed. This study provides preliminary evidence of the relationship between muscle and the chronicity of headache.

Conditions

Myofascial Trigger Points

Outcome Measures

Primary Outcomes (1)

• Pericranial muscle activity

  It was evaluated with EMG/EP equipment(9031A070 KEYPOINT Dantec) and the matching disposable needle electrode(Specification: 25mm\*0.3mm, 30G) with a sampling frequency of 125 Hz and a measuring range of 0.2mv.The spontaneous electric activity of each pericranial muscle was recorded as 0 to 4 scores: 0 score= no repeatable spontaneous electric activity, 1 score=a single, repeatable string of spontaneous electric activity, 2 scores= obvious spontaneous electric activity in two or more areas of the muscle, 3 scores= obvious spontaneous electric activity in any area of the muscle, 4 scores= a lot of spontaneous electric activity over the whole record screen. The maximum scores of a participant was 48(6\*2\*4［insertion(frontal, temporal, sternocleidomastoid, splenius capitis, splenius cervicis and trapezius) \*right or left\* maximum scores of a muscle\]).

  On the day the participant was enrolled

Secondary Outcomes (2)

• Short Form of the McGill Pain Questionnaire(SF-MPQ)

  Immediately after the enrollment

• Digital Span Test

  Immediately after the enrollment

Study Arms (3)

patients with episodic headache

Device: Electromyography

patients with chronic headache

Device: Electromyography

healthy controls

Device: Electromyography

Interventions

Electromyography DEVICE

Muscle activity was bilaterally tested with needle electromyography at rest status, targeting at myofascial trigger points (MTrPs) in the frontal, temporal, sternocleidomastoid (SCM), splenius capitis, splenius cervicis and trapezius of each subject.

healthy controls; patients with chronic headache; patients with episodic headache

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients were recruited from the headache clinic of Neurology in the first affiliated hospital of Nanjing Medical University from January/2018 to October/2018. Their diagnosis of headache were made according to the third edition of International Classification of Headache Disorders (ICHD-III).

You may qualify if:

• Have at least one onset of headache in the last week,
• Aged between 18-65 years,
• No special treatment or invasive test on pericranial muscles in the last month, and no painkillers or muscle relaxants in the last week.

You may not qualify if:

• History of surgery, trauma, tumor and spinal disease affecting the head and neck,
• Being unable to cooperate with inspection and questionnaires for any reason (severe systemic disease, bleeder, communication barriers and so on),
• People with definite mental disorders such as anxiety and depression.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Interventions

Electromyography

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Officials

• Wan Qi

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: March 26, 2019
• Study Start: January 1, 2018
• Primary Completion: October 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

CN (1)