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

Danish Headache Center46 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Tension-type Headache

Interventions

AmitriptylineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Danish Headache center

Glostrup Municipality, Denmark

Outcomes

Primary Outcomes

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.

Time frame: March 2016 to march 2018. Up to 4 months.

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.

Time frame: March 2016 to march 2018. Up to 4 months.

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.

Time frame: March 2016 to march 2018. Up to 4 months.

Data from ClinicalTrials.gov

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