Muscle Function and Strength Training of the Neck and Shoulder in Migraine and Tension-type Headache Patients. A Singel Arm Open Label Trial
NCT ID: NCT06112587
Last Updated: 2023-11-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-06
Study Completion Date
2024-05-15
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Migraine
Tension-Type Headache
Neck Pain
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
A Single-Arm Open-Label Trial
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Migraine and tension-type headache patients
Patients diagnosed by a neurologist following the 3rd edition of the International Classification of Headaches Disorders (ICHD-III)
Group Type
EXPERIMENTAL
strength training
Intervention Type
BEHAVIORAL
A targeted 8-week strength-training course was offered as an intervention in combination with ergonomics and posture corrections and recommendations
Interventions
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strength training
A targeted 8-week strength-training course was offered as an intervention in combination with ergonomics and posture corrections and recommendations
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Danish Headache Center
OTHER
Sponsor Role
lead
Responsible Party
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Bjarne Kjeldgaard Madsen
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Danish Headache Center Rigshospitalet - Glostrup
Glostrup Municipality, , Denmark
Site Status
Countries
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Denmark
References
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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.
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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.
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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.
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BACKGROUND
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.
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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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.
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BACKGROUND
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.
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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.
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BACKGROUND
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.
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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.
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BACKGROUND
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.
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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.
Reference Type
BACKGROUND
Other Identifiers
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Danish Headache center
Identifier Type: OTHER
Identifier Source: secondary_id
DHC F-23036562
Identifier Type: -
Identifier Source: org_study_id
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