Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Migraine | Study protocol

Manual therapy as a prophylactic treatment for migraine: design of a randomized controlled trial

Authors: Andreas Leonard Amons, Rene Franciscus Castien, Johannes C. van der Wouden, Willem De Hertogh, Joost Dekker, Henriëtte Eveline van der Horst

Published in: Trials | Issue 1/2019

Login to get access

Abstract

Background

People with migraine often experience disability with serious consequences for their social life and work productivity. The pharmacological prophylactic management of migraine is effective in reducing migraine attacks. However, many people are reluctant to use daily prophylactic medication, leading to a demand for non-pharmacological treatment options. We present the design for and discuss the feasibility of a pragmatic, randomized controlled trial on the effectiveness of a multimodal manual therapy (MT) treatment compared to usual care by the general practitioner (GP) for the prophylactic treatment of migraine.

Methods

Eligible participants will be recruited in primary care using the International Classification of Headache Disorders III criteria for migraine of the International Headache Society. Participants will be randomized to either multimodal MT treatment or usual care provided by the GP. GPs will be asked to treat the usual care group according to the Dutch GP guideline for headache. The multimodal MT intervention will include manual pressure techniques, neck muscle-strength exercises and mobilization of the cervical and thoracic spine.
The trial will consist of a 12-week treatment period and follow-up measurements at 12, 26 and 52 weeks. The primary outcome measure is the number of migraine days per 4 weeks, assessed with a headache diary. Secondary outcome measures are the number of migraine attacks, medication use, disability due to headache, headache intensity, number of participants reporting a 50% migraine reduction, measurement of cervical pressure pain thresholds, presence of allodynia, endurance of cervical flexor muscles, days of absence of work and global perceived effect.

Discussion

The results of the trial will show whether a multimodal MT intervention is an effective non-pharmacological treatment option for people with migraine.

Trial registration

Dutch Trial Register, NL7504. Registered on 7 February 2019.
Appendix
Available only for authorised users
Literature
1.
Steiner TJ, Stovner LJ, Katsarava Z, Lainez JM, Lampl C, Lantéri-Minet M, et al. The impact of headache in Europe: principal results of the Eurolight project. J Headache Pain. 2014;15:31.PubMedPubMedCentralCrossRef
2.
Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386:743–800.PubMedCentralCrossRef
3.
Linde M, Gustavsson A, Stovner LJ, Steiner TJ, Barré J, Katsarava Z, et al. The cost of headache disorders in Europe: the Eurolight project. Eur J Neurol. 2012;19:703–11.PubMedCrossRef
4.
Diener H-C, Charles A, Goadsby PJ, Holle D. New therapeutic approaches for the prevention and treatment of migraine. Lancet Neurol. 2015;14:1010–22.PubMedCrossRef
5.
Mulleners WM, Haan J, Dekker F, Ferrari MD. Preventieve behandeling van migraine. Ned Tijdschr Geneeskd. 2010;154:1–9.
6.
Dekker F, Dieleman JP, Neven AK, Ferrari MD, Assendelft WJ. Preventive treatment for migraine in primary care, a population-based study in the Netherlands. Cephalalgia. 2013;33:1170–8.PubMedCrossRef
7.
Coppola G, Di Lorenzo C, Serrao M, Parisi V, Schoenen J, Pierelli F. Pathophysiological targets for non-pharmacological treatment of migraine. Cephalalgia. 2016;36:1103–11.PubMedCrossRef
8.
Rist PM, Hernandez A, Bernstein C, Kowalski M, Osypiuk K, Vining R, et al. The impact of spinal manipulation on migraine pain and disability: a systematic review and meta-analysis. Headache. 2019;59:532–42.PubMedCrossRefPubMedCentral
9.
International Headache Society Clinical Trials Subcommittee, Tfelt-Hansen P, Pascual J, Ramadan N, Dahlof C, D’Amico D, et al. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia. 2012;32:6–38.CrossRef
10.
Luedtke K, Allers A, Schulte LH, May A. Efficacy of interventions used by physiotherapists for patients with headache and migraine—systematic review and meta-analysis. Cephalalgia. 2015;36:474–92.PubMedCrossRef
11.
Varatharajan S, Ferguson B, Chrobak K, Shergill Y, Côté P, Wong JJ, et al. Are non-invasive interventions effective for the management of headaches associated with neck pain? An update of the Bone and Joint Decade Task Force on Neck Pain and Its Associated Disorders by the Ontario Protocol for Traffic Injury Management (OPTIMa). Eur Spine J. 2016;25:1971–99.PubMedCrossRef
12.
Moore CS, Sibbritt DW, Adams J. A critical review of manual therapy use for headache disorders: prevalence, profiles, motivations, communication and self-reported effectiveness. BMC Neurol. 2017;17:61.PubMedPubMedCentralCrossRef
13.
Fernandez-de-las-Penas C, Cuadrado ML. Physical therapy for headaches. Cephalalgia. 2016;36:1134–42.PubMedCrossRef
14.
Goadsby PJ, Holland PR, Martins-Oliveira M, Hoffmann J, Schankin C, Akerman S. Pathophysiology of migraine: a disorder of sensory processing. Physiol Rev. 2017;97:553–622.PubMedPubMedCentralCrossRef
15.
Bartsch T, Goadsby PJ. Increased responses in trigeminocervical nociceptive neurons to cervical input after stimulation of the dura mater. Brain. 2003;126:1801–13.PubMedCrossRef
16.
Bartsch T. Migraine and the neck: new insights from basic data. Curr Pain Headache Rep. 2005;9:191–6.PubMedCrossRef
17.
18.
19.
Bartsch T, Goadsby PJ. Stimulation of the greater occipital nerve induces increased central excitability of dural afferent input. Brain. 2002;125:1496–509.PubMedCrossRef
20.
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;35:211–9.PubMedCrossRef
21.
Bigal ME, Ashina S, Burstein R, Reed ML, Buse D, Serrano D, et al. Prevalence and characteristics of allodynia in headache sufferers: a population study. Neurology. 2008;70:1525–33.PubMedCrossRef
22.
Watson DH, Drummond PD. Cervical referral of head pain in migraineurs: effects on the nociceptive blink reflex. Headache. 2014;54:1035–45.PubMedCrossRef
23.
Luedtke K, Starke W, May A. Musculoskeletal dysfunction in migraine patients. Cephalalgia. 2018;38:865–75.PubMedCrossRef
24.
Fernández-De-Las-Peñas C, Cuadrado ML, Arendt-Nielsen L, Pareja JA. Side-to-side differences in pressure pain thresholds and pericranial muscle tenderness in strictly unilateral migraine. Eur J Neurol. 2008;15:162–8.PubMedCrossRef
25.
Grossi DB, Chaves TC, Gonçalves MC, Moreira VC, Canonica AC, Florencio LL, et al. Pressure pain threshold in the craniocervical muscles of women with episodic and chronic migraine: a controlled study. Arq Neuropsiquiatr. 2011;69:607–12.PubMedCrossRef
26.
Tali D, Menahem I, Vered E, Kalichman L. Upper cervical mobility, posture and myofascial trigger points in subjects with episodic migraine: case–control study. J Bodyw Mov Ther. 2014;18:569–75.PubMedCrossRef
27.
Ferracini GN, Florencio LL, Dach F, Bevilaqua Grossi D, Palacios-Ceña M, Ordás-Bandera C, et al. Musculoskeletal disorders of the upper cervical spine in women with episodic or chronic migraine. Eur J Phys Rehabil Med. 2017;53:342–50.PubMed
28.
Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Hro A, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.PubMedPubMedCentralCrossRef
29.
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1–211.
30.
Yang M, Rendas-Baum R, Varon SF, Kosinski M. Validation of the Headache Impact Test (HIT-6™) across episodic and chronic migraine. Cephalalgia. 2011;31:357–67.PubMedPubMedCentralCrossRef
31.
Lipton RB, Bigal ME, Ashina S, Burstein R, Silberstein S, Reed ML, et al. Cutaneous allodynia in the migraine population. Ann Neurol. 2008;63:148–58.PubMedPubMedCentralCrossRef
32.
Walton DM, Levesque L, Payne M, Schick J. Clinical pressure pain threshold testing in neck pain: comparing protocols, responsiveness, and association with psychological variables. Phys Ther. 2014;94:827–37.PubMedPubMedCentralCrossRef
33.
Harris KD, Heer DM, Roy TC, Santos DM, Whitman JM, Wainner RS. Reliability of a measurement of neck flexor muscle endurance. Phys Ther. 2005;85:1349–55.PubMed
34.
Dekker F, van Duijn N, Ongering J, Bartelink M, Boelman L, Burgers J, et al. NHG-Standaard Hoofdpijn. Huisarts Wet. 2014;57:20–31.
35.
Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the use of ischemic compression and dry needling in the management of trigger points of the upper trapezius in patients with neck pain: a systematic review. Am J Phys Med Rehabil. 2015;94:573–83.PubMedCrossRef
36.
Castien RF, van der Windt DA, Grooten A, Dekker J. Effectiveness of manual therapy for chronic tension-type headache: a pragmatic, randomised, clinical trial. Cephalalgia. 2011;31:133–43.PubMedCrossRef
37.
Biller J, Sacco RL, Albuquerque FC, Demaerschalk BM, Fayad P, Long PH, et al. Cervical arterial dissections and association with cervical manipulative therapy: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014;45:3155–74.PubMedCrossRef
38.
Rushton A, Rivett D, Carlesso L, Flynn T, Hing W, Kerry R. International framework for examination of the cervical region for potential of cervical arterial dysfunction prior to orthopaedic manual therapy intervention. Man Ther. 2014;19:222–8.PubMedCrossRef
39.
Williamson A, Hoggart B. Pain: a review of three commonly used rating scales. J Clin Nurs. 2005;14:798–804.PubMedCrossRef
40.
Martin M, Blaisdell B, Kwong JW, Bjorner JB. The Short-Form Headache Impact Test (HIT-6) was psychometrically equivalent in nine languages. J Clin Epidemiol. 2004;57:1271–8.PubMedCrossRef
41.
42.
43.
Smelt AF, Blom JW, Dekker F, van den Akker ME, Knuistingh Neven A, Zitman FG, et al. A proactive approach to migraine in primary care: a pragmatic randomized controlled trial. CMAJ. 2012;184:224–31.PubMedCrossRefPubMedCentral
44.
Chaibi A, Benth JŠ, Tuchin PJ, Russell MB. Chiropractic spinal manipulative therapy for migraine: a three-armed, single-blinded, placebo, randomized controlled trial. Eur J Neurol. 2017;24:143–53.PubMedCrossRef
Metadata
Title
Manual therapy as a prophylactic treatment for migraine: design of a randomized controlled trial
Authors
Andreas Leonard Amons
Rene Franciscus Castien
Johannes C. van der Wouden
Willem De Hertogh
Joost Dekker
Henriëtte Eveline van der Horst
Publication date
01-12-2019
Publisher
BioMed Central
Keywords
Migraine
Headache
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3937-8

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

Effects of oral Nigella sativa oil on the expression levels and serum concentrations of adiponectin, PPAR-γ, and TNF-α in overweight and obese women: a study protocol for a crossover-designed, double-blind, placebo-controlled randomized clinical trial

Research

Investigating modifications to participant information materials to improve recruitment into a large randomized trial

Methodology

What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study

Study protocol

Jin’s three-needle acupuncture technique for chronic fatigue syndrome: a study protocol for a multicentre, randomized, controlled trial

Study protocol

A self-guided Internet-based intervention for individuals with gambling problems: study protocol for a randomized controlled trial

Study protocol

Evaluation of clinical efficacy of silver-needle warm acupuncture in treating adults with acute low back pain due to lumbosacral disc herniation: study protocol for a randomized controlled trial