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

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. Identifier: NCT02746250
Recruitment Status : Recruiting
First Posted : April 21, 2016
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Lærke Tørring Kolding, 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.

Condition or disease Intervention/treatment
Tension-type Headache Drug: Amitriptyline

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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.
Study Start Date : March 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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.

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

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

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 identifier (NCT number): NCT02746250

Contact: Lærke T Kolding 0045 38633746

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

Responsible Party: Lærke Tørring Kolding, Medical student, Danish Headache Center Identifier: NCT02746250     History of Changes
Other Study ID Numbers: H-16000619
First Posted: April 21, 2016    Key Record Dates
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:
Tension-Type Headache
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
Antidepressive Agents, Tricyclic
Amitriptyline, perphenazine drug combination
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
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