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

Not Applicable

Completed

• Conditions: Tension-type Headache
• Interventions: Drug: Amitriptyline

• Registration Number: NCT02746250
• Lead Sponsor: Danish Headache Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tension type headache	Amitriptyline	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.

Primary Outcome Measures

Name	Time	Method
Change in Total Tenderness Score	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.
Change in muscle stiffness	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.
Change in Local Tenderness Score	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.

Trial Locations

Locations (1)

Danish Headache center; 🇩🇰 Glostrup, Denmark