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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tension-type Headache

Intervention / Treatment
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* Drug: Amitriptyline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tension type headache<br>The investigator measures the muscle soreness and muscle stiffness before the patients starts their prescribed treatment with amitriptyline - and again after they have reached their optimal dosage of amitriptyline. | Drug: Amitriptyline<br>* 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.<br>* Other names: Tricyclic antidepressants;|
| No Intervention: Healthy controls<br>The investigator measures the muscle soreness and muscle stiffness once. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. |