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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06112587
Other study ID # DHC F-23036562
Secondary ID Danish Headache
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 6, 2023
Est. completion date May 15, 2024

Study information

Verified date October 2023
Source Danish Headache Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date May 15, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Denmark Danish Headache Center Rigshospitalet - Glostrup Glostrup

Sponsors (1)

Lead Sponsor Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

References & Publications (27)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 27 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Maximal Voluntary Contraction of the Neck extension Maximal force of the neck extension (Newtons) Before intervention, after intervention and at 1 month follow up
Other Maximal Voluntary Contraction of the Neck flexion Maximal force of the neck flexion (Newtons) Before intervention, after intervention and at 1 month follow up
Other Maximal Voluntary Contraction of the Shoulder elevation Maximal force of the shoulder elevation (Newtons) Before intervention, after intervention and at 1 month follow up
Other Moment arm for neck flexion and extension Distance between C7 and Protuberancia occipitalis (m) Before intervention
Other Moment arm for shoulder elevation Distance between C7 and acromion of the right shoulder (m) Before intervention
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Other Muscle tenderness Total Tenderness Score (0-48) Before intervention, after intervention and at 1 month follow up
Other 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
Other 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
Other 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
Other Exercise sessions completed Number of training sessions performed by the participants During the intervention
Other Percieved intensity Level of intensity percieved by patients in each exercise session During the intervention
Other Intensity coherence Ratio between average of rate of percieved exertion by the patients and 10 (coefficient from 0 to 1). post-intervention
Other 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
Other Adherence to exercise Ratio between the number of exercise sessions completed after intervention until the follow-up. Week 1 to 5 after intervention
Other Compliance of the programm Product between intensity coherence and adherence. post-intervention
Primary headache frequency number of days with headache two weeks prior to intervention, last two weeks of intervention
Secondary 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
Secondary 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
Secondary 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
Secondary headache duration hours with headache two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary headache frequency number of days with headache weeks 4 and 5 after intervention
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