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

Sponsor

Danish Headache Center (Other)

Overall Status

Completed

CT.gov ID

NCT02746250

Collaborator

(none)

Enrollment

Location

Arms

10.1

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Tension-type Headache	Drug: Amitriptyline	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

46 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 :

Mar 1, 2016

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

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