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OpenTrials
Completed

NCT Number: NCT02746250

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

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.

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Key information

Conditions

Tension-type Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache center

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amitriptyline

Drug

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.

Other names: Saroten, Tricyclic antidepressants

Primary outcomes

  1. Change in Total Tenderness Score

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

    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.

  2. Change in muscle stiffness

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

    The stiffness is measured in terms of the speed of the shear waves (meter/second) the higher the speed the stiffer the muscle.

  3. Change in Local Tenderness Score

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

    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.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2016
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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