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

NCT ID: NCT02746250

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-01-31

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.

Conditions

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Tension-type Headache

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tension type headache

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.

Group Type ACTIVE_COMPARATOR

Amitriptyline

Intervention Type 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.

Healthy controls

The investigator measures the muscle soreness and muscle stiffness once.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Saroten Tricyclic antidepressants

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Lærke Tørring Kolding

Medical student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henrik W Schytz, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center, Department of neurology, Rigshospitalet Glostrup

Locations

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Danish Headache center

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-16000619

Identifier Type: -

Identifier Source: org_study_id

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