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

This study is currently recruiting participants.
Verified April 2016 by Lærke Tørring Kolding, Danish Headache Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02746250
First Posted: April 21, 2016
Last Update Posted: April 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lærke Tørring Kolding, Danish Headache Center
  Purpose
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.

Condition Intervention
Tension-type Headache Drug: Amitriptyline

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.

Resource links provided by NLM:


Further study details as provided by Lærke Tørring Kolding, Danish Headache Center:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.


Estimated Enrollment: 90
Study Start Date: March 2016
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: 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.
Other Names:
  • Saroten
  • Tricyclic antidepressants
No Intervention: Healthy controls
The investigator measures the muscle soreness and muscle stiffness once.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746250


Contacts
Contact: Lærke T Kolding 0045 38633746 laerke.toerring.kolding.01@regionh.dk

Locations
Denmark
Danish Headache center Recruiting
Glostrup, Denmark, 2600
Contact: Henrik Schytz, MD         
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Henrik W Schytz, MD, DMSc Danish Headache Center, Department of neurology, Rigshospitalet Glostrup
  More Information

Responsible Party: Lærke Tørring Kolding, Medical student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02746250     History of Changes
Other Study ID Numbers: H-16000619
First Submitted: April 13, 2016
First Posted: April 21, 2016
Last Update Posted: April 21, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Myalgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Neuromuscular Diseases
Amitriptyline
Antidepressive Agents, Tricyclic
Amitriptyline, perphenazine drug combination
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents