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

NCT02746250 | Completed DMC

• 1 other identifier: H-16000619
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Tension-type Headache

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Tension type headache

ACTIVE COMPARATOR

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

Healthy controls

NO INTERVENTION

The investigator measures the muscle soreness and muscle stiffness once.

Interventions

Amitriptyline 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.

Also known as: Saroten, Tricyclic antidepressants

Tension type headache

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache center

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Amitriptyline; Antidepressive Agents, Tricyclic

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Antidepressive Agents; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Henrik W Schytz, MD, DMSc

  Danish Headache Center, Department of neurology, Rigshospitalet Glostrup

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical student

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 21, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)