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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine; Neck Pain; Tension-Type Headache
• Intervention / Treatment: Behavioral: strength training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Danish Headache Center Rigshospitalet - Glostrup

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
headache frequency	number of days with headache	two weeks prior to intervention, last two weeks of intervention

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Danish Headache Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Andersen LL, Kjaer M, Andersen CH, Hansen PB, Zebis MK, Hansen K, Sjogaard G. Muscle activation during selected strength exercises in women with chronic neck muscle pain. Phys Ther. 2008 Jun;88(6):703-11. doi: 10.2522/ptj.20070304. Epub 2008 Mar 13.
• van Ettekoven H, Lucas C. Efficacy of physiotherapy including a craniocervical training programme for tension-type headache; a randomized clinical trial. Cephalalgia. 2006 Aug;26(8):983-91. doi: 10.1111/j.1468-2982.2006.01163.x.
• 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.
• Jull GA, Falla D, Vicenzino B, Hodges PW. The effect of therapeutic exercise on activation of the deep cervical flexor muscles in people with chronic neck pain. Man Ther. 2009 Dec;14(6):696-701. doi: 10.1016/j.math.2009.05.004. Epub 2009 Jul 25.
• 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.
• 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.
• Horn KK, Jennings S, Richardson G, Vliet DV, Hefford C, Abbott JH. The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure. J Orthop Sports Phys Ther. 2012 Jan;42(1):30-42. doi: 10.2519/jospt.2012.3727. Epub 2011 Oct 25.
• Jull GA, O'Leary SP, Falla DL. Clinical assessment of the deep cervical flexor muscles: the craniocervical flexion test. J Manipulative Physiol Ther. 2008 Sep;31(7):525-33. doi: 10.1016/j.jmpt.2008.08.003.
• 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.
• 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. Erratum In: J Headache Pain. 2021 Oct 6;22(1):116.
• 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.
• 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.
• 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.
• 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.
• 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). 2019 Mar 28:S0213-4853(19)30024-6. doi: 10.1016/j.nrl.2018.12.006. Online ahead of print. English, Spanish.
• 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.
• 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.
• Ashina H, Al-Khazali HM, Iljazi A, Ashina S, Amin FM, Schytz HW. Total tenderness score and pressure pain thresholds in persistent post-traumatic headache attributed to mild traumatic brain injury. J Headache Pain. 2022 Aug 8;23(1):96. doi: 10.1186/s10194-022-01457-1.
• Bendtsen L, Jensen R, Jensen NK, Olesen J. Pressure-controlled palpation: a new technique which increases the reliability of manual palpation. Cephalalgia. 1995 Jun;15(3):205-10. doi: 10.1046/j.1468-2982.1995.015003205.x.
• Cummins D, Rivett DA, Thomas LC, Osmotherly PG. Reproduction and resolution of familiar head pain with upper cervical spine sustained joint mobilization may help identify cervicogenic headaches: a case-control study. J Man Manip Ther. 2023 Jun;31(3):198-205. doi: 10.1080/10669817.2022.2099181. Epub 2022 Jul 18.
• Takasaki H, Yamasaki C. Immediate neck hypoalgesic effects of craniocervical flexion exercises and cervical retraction exercises among individuals with non-acute neck pain and a directional preference for retraction or extension: preliminary pretest-posttest randomized experimental design. J Man Manip Ther. 2023 Oct;31(5):368-375. doi: 10.1080/10669817.2023.2201918. Epub 2023 Apr 13.
• Andersen LL, Kjaer M, Sogaard K, Hansen L, Kryger AI, Sjogaard G. Effect of two contrasting types of physical exercise on chronic neck muscle pain. Arthritis Rheum. 2008 Jan 15;59(1):84-91. doi: 10.1002/art.23256.
• Fernandez-de-Las-Penas C, Cuadrado ML, Pareja JA. Myofascial trigger points, neck mobility, and forward head posture in episodic tension-type headache. Headache. 2007 May;47(5):662-72. doi: 10.1111/j.1526-4610.2006.00632.x.
• Fernandez-de-Las-Penas C, Cuadrado ML, Pareja JA. Myofascial trigger points, neck mobility and forward head posture in unilateral migraine. Cephalalgia. 2006 Sep;26(9):1061-70. doi: 10.1111/j.1468-2982.2006.01162.x.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2023
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): May 15, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: exercise; strength training; neck pain; migraine; tension-type headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Neck Pain; Migraine Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: DHC F-23036562; Danish Headache center (Other Identifier: Rigshospitalet Glostrup)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: At the moment of publication and thereafter
• IPD Sharing Access Criteria: After its publication, according to the journal's policy and under the consensus of all authors.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No