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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06112587
Acronym
MUST-MITH
Enrollment
30
Registered
2023-11-01
Start date
2023-10-06
Completion date
2024-05-15
Last updated
2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine, Neck Pain, Tension-Type Headache

Keywords

migraine, tension-type headache, strength training, neck pain, exercise

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.

Interventions

BEHAVIORALstrength training

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

Sponsors

Danish Headache Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A Single-Arm Open-Label Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
headache frequencytwo weeks prior to intervention, last two weeks of interventionnumber of days with headache

Secondary

MeasureTime frameDescription
neck pain average intensitytwo weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after interventionaverage neck pain intensity percieved by patient in a 0-10 NRPS
neck pain frequencytwo weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after interventionnumber of days with neck pain
headache durationtwo weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after interventionhours with headache
medication intaketwo weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after interventionnumber of days with medication for pain taked
neck pain maximal intensitytwo weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after interventionmaximal neck pain intensity percieved by patient in a 0-10 NRPS
Headache average Intensitytwo weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after interventionaverage headache intensity percieved by patient in a 0-10 NRPS
Headache maximal Intensitytwo weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after interventionmaximal headache intensity percieved by patient in a 0-10 NRPS
headache frequencyweeks 4 and 5 after interventionnumber of days with headache
Functional levelBefore intervention, after intervention and at 1 month follow upSelf-reported limitated activities due to headache in a 0-10 scale thourgh the Patient-Specific Functional Scale

Other

MeasureTime frameDescription
Moment arm fof the shoulder elevationBefore intervention, after intervention and at 1 month follow upPeak of the Maximal Voluntary Contraction x Moment arm of the shoulder elevation (N\*m)
Extension-Flexion ratioBefore intervention, after intervention and at 1 month follow upRatio between moment arm of the neck extension and moment arm of the neck flexion.
Rate of force development of the shoulder elevationBefore 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 elevationBefore 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 tendernessBefore intervention, after intervention and at 1 month follow upTotal Tenderness Score (0-48)
Percieved intensityDuring the interventionLevel of intensity percieved by patients in each exercise session
Muscle tenderness of the neckBefore intervention, after intervention and at 1 month follow upTotal Tenderness Score of the last 4 spots: mastoid process, sternocleidmastoid, occipitalis and superior trapezius (0-24)
Craniocervical flexion scoreBefore intervention, after intervention and at 1 month follow upCraniocervical flexion test score. Possible values: 20, 22, 24, 26, 28 or 30 mmHg
Exercise sessions completedDuring the interventionNumber of training sessions performed by the participants
Adherence to exerciseWeek 1 to 5 after interventionRatio between the number of exercise sessions completed after intervention until the follow-up.
Compliance of the programmpost-interventionProduct between intensity coherence and adherence.
Muscle tenderness of the faceBefore intervention, after intervention and at 1 month follow upTotal Tenderness Score of the first 4 spots: masseter, coronoid process, temporalis and frontalis (0-24)
Intensity coherencepost-interventionRatio between average of rate of percieved exertion by the patients and 10 (coefficient from 0 to 1).
Adherence of the programmpost-interventionRatio between the number of exercise sessions completed by patients versus number of exercise sessions planned in the programm
Maximal Voluntary Contraction of the Neck extensionBefore intervention, after intervention and at 1 month follow upMaximal force of the neck extension (Newtons)
Maximal Voluntary Contraction of the Neck flexionBefore intervention, after intervention and at 1 month follow upMaximal force of the neck flexion (Newtons)
Maximal Voluntary Contraction of the Shoulder elevationBefore intervention, after intervention and at 1 month follow upMaximal force of the shoulder elevation (Newtons)
Moment arm for neck flexion and extensionBefore interventionDistance between C7 and Protuberancia occipitalis (m)
Moment arm for shoulder elevationBefore interventionDistance between C7 and acromion of the right shoulder (m)
Moment arm for neck flexionBefore intervention, after intervention and at 1 month follow upPeak of the Maximal Voluntary Contraction x Moment arm of the neck flexion (N\*m)
Moment arm of the neck extensionBefore intervention, after intervention and at 1 month follow upPeak of the Maximal Voluntary Contraction x Moment arm of the neck extension (N\*m)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026