Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.

Tension-type Headache Clinical Trial

Official title:

Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746250
• Other study ID #: H-16000619
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: January 2017

Study information

• Verified date: February 2019
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to investigate muscle soreness and stiffness in patients with Chronic or Frequent Episodic Tension Type Headache before and after treatment with amitriptyline - and to compare the results with healthy individuals.

Description:

The muscle stiffness is measured with ultrasonic shear wave elastography in m. masseter, m. sternocleidomastoid and m. Trapezius.

The muscle soreness is measured by palpation of the muscles aided by a so called palpometer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Chronic Tension type headache or frequent episodic tension type headache with at least ten episodes or more per month throughout three months or more.

• Pericranial muscle tenderness

Exclusion Criteria:

• Other primary headache disorder (with the exception of episodic migraine.)

• Pregnancy or ongoing breastfeeding

• Heart disease that contradicts treatment with amitriptyline

• Drug or substance abuse

Related Conditions & MeSH terms

• Headache
• Myalgia
• Tension-type Headache

Intervention

Drug:
• Amitriptyline
The investigator recruits patients who have already discussed and agreed to the amitriptyline treatment with their physician. The patients start the treatment after the investigator have measured them once.

Locations

Country	Name	City	State
Denmark	Danish Headache center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Tenderness Score	The soreness of the muscle is reported by the patient on a scale from 0-3 (0= no pain, 1= mild pain, 2= moderate pain and 3= severe pain) when pressure is applied at eight different locations on both sides of the face and neck (m. masseter, m. frontalis, m. pterygoideus lateralis, m. temporalis, m. sternocleidomastoid, pros. mastoideus, m. trapezius and the insertions of the neck muscles at the base of the scull.) The sum of the individual scores make up the total tenderness.	March 2016 to march 2018. Up to 4 months.
Primary	Change in muscle stiffness	The stiffness is measured in terms of the speed of the shear waves (meter/second) the higher the speed the stiffer the muscle.	March 2016 to march 2018. Up to 4 months.
Primary	Change in Local Tenderness Score	Aided by a palpometer a pressure of 160 U is applied to four different locations (m. masseter, m. sternocleidomastoid, the lateral part of m. trapezius and the medial part of the m. trapezius.) At each location the patient report the pain intensity on a scale from 0-10.	March 2016 to march 2018. Up to 4 months.