MUST-MITH: Muscle Function and Strength Training of the Neck and Shoulder in Migraine and Tension-type Headache Patients. A Singel Arm Open Label Trial

Sponsor

Danish Headache Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06112587

Collaborator

(none)

Enrollment

Location

Arm

7.3

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Single-Arm Open-Label Trial was performed at the Danish Headache Center (DHC), Department of Neurology, Rigshospitalet - Glostrup as part of the clinic.

Purpose:

To examine the effects of supervised group strength training and posture correction on headache frequency and muscle function around the neck and shoulders in patients with migraine and tension-type headaches.

Hypothesis:

Strength training of the neck and shoulders results in improved muscle function, which leads to a reduction in headache.

Condition or Disease	Intervention/Treatment	Phase
Migraine Tension-Type Headache Neck Pain	Behavioral: strength training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

A Single-Arm Open-Label TrialA Single-Arm Open-Label Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Muscle Function and Strength Training of the Neck and Shoulder in Migraine and Tension-type Headache Patients.

Actual Study Start Date :

Oct 6, 2023

Anticipated Primary Completion Date :

May 15, 2024

Anticipated Study Completion Date :

May 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Migraine and tension-type headache patients Patients diagnosed by a neurologist following the 3rd edition of the International Classification of Headaches Disorders (ICHD-III)	Behavioral: strength training A targeted 8-week strength-training course was offered as an intervention in combination with ergonomics and posture corrections and recommendations

Arm

Intervention/Treatment

Experimental: Migraine and tension-type headache patients

Patients diagnosed by a neurologist following the 3rd edition of the International Classification of Headaches Disorders (ICHD-III)

Behavioral: strength training

A targeted 8-week strength-training course was offered as an intervention in combination with ergonomics and posture corrections and recommendations

Outcome Measures

Primary Outcome Measures

headache frequency [two weeks prior to intervention, last two weeks of intervention]
number of days with headache

Secondary Outcome Measures

neck pain maximal intensity [two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention]
maximal neck pain intensity percieved by patient in a 0-10 NRPS
neck pain average intensity [two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention]
average neck pain intensity percieved by patient in a 0-10 NRPS
neck pain frequency [two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention]
number of days with neck pain
headache duration [two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention]
hours with headache
medication intake [two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention]
number of days with medication for pain taked
Functional level [Before intervention, after intervention and at 1 month follow up]
Self-reported limitated activities due to headache in a 0-10 scale thourgh the Patient-Specific Functional Scale
Headache average Intensity [two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention]
average headache intensity percieved by patient in a 0-10 NRPS
Headache maximal Intensity [two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention]
maximal headache intensity percieved by patient in a 0-10 NRPS
headache frequency [weeks 4 and 5 after intervention]
number of days with headache

Other Outcome Measures

Maximal Voluntary Contraction of the Neck extension [Before intervention, after intervention and at 1 month follow up]
Maximal force of the neck extension (Newtons)
Maximal Voluntary Contraction of the Neck flexion [Before intervention, after intervention and at 1 month follow up]
Maximal force of the neck flexion (Newtons)
Maximal Voluntary Contraction of the Shoulder elevation [Before intervention, after intervention and at 1 month follow up]
Maximal force of the shoulder elevation (Newtons)
Moment arm for neck flexion and extension [Before intervention]
Distance between C7 and Protuberancia occipitalis (m)
Moment arm for shoulder elevation [Before intervention]
Distance between C7 and acromion of the right shoulder (m)
Moment arm for neck flexion [Before intervention, after intervention and at 1 month follow up]
Peak of the Maximal Voluntary Contraction x Moment arm of the neck flexion (N*m)
Moment arm of the neck extension [Before intervention, after intervention and at 1 month follow up]
Peak of the Maximal Voluntary Contraction x Moment arm of the neck extension (N*m)
Moment arm fof the shoulder elevation [Before intervention, after intervention and at 1 month follow up]
Peak of the Maximal Voluntary Contraction x Moment arm of the shoulder elevation (N*m)
Extension-Flexion ratio [Before intervention, after intervention and at 1 month follow up]
Ratio between moment arm of the neck extension and moment arm of the neck flexion.
Rate of force development of the shoulder elevation [Before intervention, after intervention and at 1 month follow up]
(75% of the peak value of the shoulder elevation (N) - 25% of the peak value of the shoulder elevation)/(time at de 75% of the peak of shoulder elevation (s) - time at 25% of the peak of shoulder elevation) in Newtons per second (N/s)
Early rate of force development of the shoulder elevation [Before intervention, after intervention and at 1 month follow up]
(Value of the peak of the shoulder elevation at 250ms after the 2,5% of the peak (N) - 2,5% of the peak value of the shoulder elevation)/0,250 (s) in Newtons per second (N/s)
Muscle tenderness [Before intervention, after intervention and at 1 month follow up]
Total Tenderness Score (0-48)
Muscle tenderness of the face [Before intervention, after intervention and at 1 month follow up]
Total Tenderness Score of the first 4 spots: masseter, coronoid process, temporalis and frontalis (0-24)
Muscle tenderness of the neck [Before intervention, after intervention and at 1 month follow up]
Total Tenderness Score of the last 4 spots: mastoid process, sternocleidmastoid, occipitalis and superior trapezius (0-24)
Craniocervical flexion score [Before intervention, after intervention and at 1 month follow up]
Craniocervical flexion test score. Possible values: 20, 22, 24, 26, 28 or 30 mmHg
Exercise sessions completed [During the intervention]
Number of training sessions performed by the participants
Percieved intensity [During the intervention]
Level of intensity percieved by patients in each exercise session
Intensity coherence [post-intervention]
Ratio between average of rate of percieved exertion by the patients and 10 (coefficient from 0 to 1).
Adherence of the programm [post-intervention]
Ratio between the number of exercise sessions completed by patients versus number of exercise sessions planned in the programm
Adherence to exercise [Week 1 to 5 after intervention]
Ratio between the number of exercise sessions completed after intervention until the follow-up.
Compliance of the programm [post-intervention]
Product between intensity coherence and adherence.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Migraine patients with stable CGRP or botox.
Tension type headache with no more than 5 migraine days/month.
At least four days/months of headache at the moment of recruitment.

Exclusion Criteria:

Pregnancy
Post-traumatic headache, or headache that is likely to be associated with trauma.
Significant psychiatric comorbidities, such as severe depression
Medication Overuse Headaches.
Severe arthrosis in the neck, shoulder, or disc herniation in the neck.