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MigraineMUST-MITHNCT06112587

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

A study testing strength training in people with Migraine and Tension-Type Headache, run by Danish Headache Center at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine, Tension-Type Headache, Neck Pain
What is being tested?
strength training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteDenmark
Study dates
6 Oct 2023to 15 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Danish Headache Center Rigshospitalet - Glostrup

    Glostrup Municipality, 2600

Other trials in Denmark

About this study

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

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.

Being tested
strength training
Keywords
migraine, tension-type headache, strength training, neck pain, exercise
Medical subject headings
Migraine Disorders, Tension-Type Headache, Neck Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • strength trainingBehavioural

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

Study groups in NCT06112587
Study groupRoleWhat they receive
Migraine and tension-type headache patientsExperimentalPatients diagnosed by a neurologist following the 3rd edition of the International Classification of Headaches Disorders (ICHD-III)
Receives: Behavioral: strength training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. headache frequency

    number of days with headache

    Measured: two weeks prior to intervention, last two weeks of intervention

Secondary outcomes (9)

  1. neck pain maximal intensity

    maximal neck pain intensity percieved by patient in a 0-10 NRPS

    Measured: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention

  2. neck pain average intensity

    average neck pain intensity percieved by patient in a 0-10 NRPS

    Measured: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention

  3. neck pain frequency

    number of days with neck pain

    Measured: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention

  4. headache duration

    hours with headache

    Measured: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention

  5. medication intake

    number of days with medication for pain taked

    Measured: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention

  6. Functional level

    Self-reported limitated activities due to headache in a 0-10 scale thourgh the Patient-Specific Functional Scale

    Measured: Before intervention, after intervention and at 1 month follow up

  7. Headache average Intensity

    average headache intensity percieved by patient in a 0-10 NRPS

    Measured: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention

  8. Headache maximal Intensity

    maximal headache intensity percieved by patient in a 0-10 NRPS

    Measured: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention

  9. headache frequency

    number of days with headache

    Measured: weeks 4 and 5 after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2023
  2. Study start6 Oct 2023
  3. Primary completion15 May 2024 (estimated)
  4. Study completion15 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A Single-Arm Open-Label Trial
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06112587
Sponsor's protocol ID
DHC F-23036562
Other IDs
Danish Headache center
Acronym
MUST-MITH
Status last verified
Oct 2023
First submitted
10 Oct 2023
Last updated
1 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Publications

  • Steiner TJ, Gururaj G, Andree C, Katsarava Z, Ayzenberg I, Yu SY, Al Jumah M, Tekle-Haimanot R, Birbeck GL, Herekar A, Linde M, Mbewe E, Manandhar K, Risal A, Jensen R, Queiroz LP, Scher AI, Wang SJ, Stovner LJ. Diagnosis, prevalence estimation and burden measurement in population surveys of headache: presenting the HARDSHIP questionnaire. J Headache Pain. 2014 Jan 8;15(1):3. doi: 10.1186/1129-2377-15-3.

    PubMed 24400999

  • Linde M, Gustavsson A, Stovner LJ, Steiner TJ, Barre J, Katsarava Z, Lainez JM, Lampl C, Lanteri-Minet M, Rastenyte D, Ruiz de la Torre E, Tassorelli C, Andree C. The cost of headache disorders in Europe: the Eurolight project. Eur J Neurol. 2012 May;19(5):703-11. doi: 10.1111/j.1468-1331.2011.03612.x. Epub 2011 Dec 5.

    PubMed 22136117

  • Kroll LS, Callesen HE, Carlsen LN, Birkefoss K, Beier D, Christensen HW, Jensen M, Tomasdottir H, Wurtzen H, Host CV, Hansen JM. Manual joint mobilisation techniques, supervised physical activity, psychological treatment, acupuncture and patient education for patients with tension-type headache. A systematic review and meta-analysis. J Headache Pain. 2021 Aug 21;22(1):96. doi: 10.1186/s10194-021-01298-4.

    PubMed 34418953

  • Di Antonio S, Arendt-Nielsen L, Castaldo M. Cervical musculoskeletal impairments and pain sensitivity in migraine patients. Musculoskelet Sci Pract. 2023 Aug;66:102817. doi: 10.1016/j.msksp.2023.102817. Epub 2023 Jul 6.

    PubMed 37451884

  • Di Antonio S, Arendt-Nielsen L, Ponzano M, Bovis F, Torelli P, Pelosin E, Finocchi C, Castaldo M. Migraine patients with and without neck pain: Differences in clinical characteristics, sensitization, musculoskeletal impairments, and psychological burden. Musculoskelet Sci Pract. 2023 Aug;66:102800. doi: 10.1016/j.msksp.2023.102800. Epub 2023 Jun 14.

    PubMed 37344290

  • Ashina S, Bendtsen L, Lyngberg AC, Lipton RB, Hajiyeva N, Jensen R. Prevalence of neck pain in migraine and tension-type headache: a population study. Cephalalgia. 2015 Mar;35(3):211-9. doi: 10.1177/0333102414535110. Epub 2014 May 22.

    PubMed 24853166

  • Andersen LL, Suetta C, Andersen JL, Kjaer M, Sjogaard G. Increased proportion of megafibers in chronically painful muscles. Pain. 2008 Oct 31;139(3):588-593. doi: 10.1016/j.pain.2008.06.013. Epub 2008 Aug 12.

    PubMed 18701218

  • Madsen BK, Sogaard K, Andersen LL, Tornoe B, Jensen RH. Efficacy of strength training on tension-type headache: A randomised controlled study. Cephalalgia. 2018 May;38(6):1071-1080. doi: 10.1177/0333102417722521. Epub 2017 Jul 27.

    PubMed 28750588

  • Plotkin DL, Roberts MD, Haun CT, Schoenfeld BJ. Muscle Fiber Type Transitions with Exercise Training: Shifting Perspectives. Sports (Basel). 2021 Sep 10;9(9):127. doi: 10.3390/sports9090127.

    PubMed 34564332

  • Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

    PubMed 29368949

  • Gago-Veiga AB, Camina Muniz J, Garcia-Azorin D, Gonzalez-Quintanilla V, Ordas CM, Torres-Ferrus M, Santos-Lasaosa S, Viguera-Romero J, Pozo-Rosich P. Headache: What to ask, how to examine, and which scales to use. Recommendations of the Spanish Society of Neurology's Headache Study Group. Neurologia (Engl Ed). 2022 Sep;37(7):564-574. doi: 10.1016/j.nrl.2018.12.006. Epub 2019 Mar 28. English, Spanish.

    PubMed 30929913

  • Madsen BK, Sogaard K, Andersen LL, Skotte JH, Jensen RH. Neck and shoulder muscle strength in patients with tension-type headache: A case-control study. Cephalalgia. 2016 Jan;36(1):29-36. doi: 10.1177/0333102415576726. Epub 2015 Apr 1.

    PubMed 25834271

  • Andersen LL, Nielsen PK, Sogaard K, Andersen CH, Skotte J, Sjogaard G. Torque-EMG-velocity relationship in female workers with chronic neck muscle pain. J Biomech. 2008;41(9):2029-35. doi: 10.1016/j.jbiomech.2008.03.016. Epub 2008 May 5.

    PubMed 18460408

  • Andersen LL, Andersen JL, Zebis MK, Aagaard P. Early and late rate of force development: differential adaptive responses to resistance training? Scand J Med Sci Sports. 2010 Feb;20(1):e162-9. doi: 10.1111/j.1600-0838.2009.00933.x. Epub 2009 May 26.

    PubMed 19793220

  • Maffiuletti NA, Aagaard P, Blazevich AJ, Folland J, Tillin N, Duchateau J. Rate of force development: physiological and methodological considerations. Eur J Appl Physiol. 2016 Jun;116(6):1091-116. doi: 10.1007/s00421-016-3346-6. Epub 2016 Mar 3.

    PubMed 26941023

Questions about this trial

What is this clinical trial studying?

A study testing strength training in people with Migraine and Tension-Type Headache, run by Danish Headache Center at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

headache frequency (time frame: two weeks prior to intervention, last two weeks of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06112587, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.

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