Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache - a protocol of a pragmatic randomized controlled trial

Kiran Satpute, Nilima Bedekar, Toby Hall, Kiran Satpute, Nilima Bedekar, Toby Hall

Abstract

Background: Non - pharmacological management of migraine, tension-type headache (TTH), and cervicogenic headache (CGH) may include spinal manual therapy and exercise. Mulligan Manual Therapy (MMT) utilizes a protocol of headache elimination procedures to manage headache parameters and associated disability, but has only been evaluated in CGH. There is little evidence for its effectiveness in migraine and TTH. This study aims to determine the effectiveness of MMT and exercise over exercise and placebo in the management of migraine, TTH, and CGH.

Methods: This pragmatic trial is designed as a prospective, three-armed randomised controlled trial in a clinical setting provided at a general hospital physiotherapy department. Two hundred ninety-seven participants with a diagnosis of migraine, TTH or CGH based on published headache classification guidelines will be included. An assessor blind to group allocation will measure outcomes pre-and post-intervention as well as 3 and 6 months after commencement of treatment. Participants will be allocated to one of the three groups: MMT and exercise; placebo and exercise; and exercise alone. The primary outcome measure is headache frequency. Secondary outcome measures are headache duration and intensity, medication intake, pressure pain threshold (PPT), range of motion recorded with the flexion rotation test, and headache disability recorded with Headache Activities of Daily Living Index (HADLI). The intention-to-treat principle will be followed for statistical analysis. Between groups differences for all outcome measures at baseline and at reassessment points and 95% confidence intervals will be calculated using a mixed model ANOVA. Post hoc tests will be conducted to identify any significant difference between groups and over time.

Discussion: This pragmatic study will provide evidence for the effectiveness of MMT when compared with a placebo intervention and exercise on headache frequency, intensity, and disability. Limitations are that baseline evaluation of headache parameters may be affected by recall bias. External validity will be limited to the population with a minimum 1-year history of headache. The HADLI is not yet extensively evaluated for its psychometric properties and association between PPT and headache parameters is lacking. Performance bias is inevitable as a single therapist will be delivering all interventions.

Trial registration: The trial was registered prospectively under the Clinical Trial Registry India (Registration number: CTRI/2019/06/019506 , dated on 03/06/2019). .

Keywords: Cervicogenic headache; Disability; Headache; Manual therapy; Migraine; Mulligan manual therapy; Tension-type headache.

Conflict of interest statement

Toby Hall and Kiran Satpute are accredited Mulligan concept teachers. Both are members of the Mulligan Concept Teachers Associations. They gain a teaching fee when running these courses.

Figures

Fig. 1
Fig. 1
Flow chart of the study process based on SPIRIT guidelines (2013)
Fig. 2
Fig. 2
Mulligan Manual Therapy techniques

References

    1. Leonardi M, Raggi A. A narrative review on the burden of migraine: when the burden is the impact on people’s life. J Headache Pain. 2019;20:41. doi: 10.1186/s10194-019-0993-0.
    1. Jensen R, Stovner LJ. Epidemiology and comorbidity of headache. Lancet Neurol. 2008;7:354–361. doi: 10.1016/S1474-4422(08)70062-0.
    1. Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the global burden of disease study 2010. Lancet Lond Engl. 2012;380:2163–2196. doi: 10.1016/S0140-6736(12)61729-2.
    1. Sjaastad O, Bakketeig LS. Prevalence of cervicogenic headache: Vågå study of headache epidemiology. Acta Neurol Scand. 2008;117:173–180. doi: 10.1111/j.1600-0404.2007.00962.x.
    1. Headache Classification Committee of the International Headache Society (IHS). . Accessed 20 July 2020.
    1. Dale PC, Thomas JC, Hazle CR. Physical therapist clinical reasoning and classification inconsistencies in headache disorders: a United States survey. J Man Manip Ther. 2020;28:28–40. doi: 10.1080/10669817.2019.1645414.
    1. Schytz HW. Testing the diagnostic criteria of tension-type headache: Cephalalgia. 2018.
    1. Blumenfeld A, Siavoshi S. The challenges of Cervicogenic headache. Curr Pain Headache Rep. 2018;22:47. doi: 10.1007/s11916-018-0699-z.
    1. Nachit-Ouinekh F, Chrysostome V, Henry P, Sourgen C, Dartigues JF, El Hasnaoui A. Variability of reported headache symptoms and diagnosis of migraine at 12 months. Cephalalgia Int J Headache. 2005;25:117–123. doi: 10.1111/j.1468-2982.2004.00816.x.
    1. Yi XB, Cook AJ, Hamill-Ruth RJ, Rowlingson JC. Cervicogenic headache in patients with presumed migraine: missed diagnosis or misdiagnosis? J Pain. 2005;6:700–703. doi: 10.1016/j.jpain.2005.04.005.
    1. 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 Int J Headache. 2016;36:474–492. doi: 10.1177/0333102415597889.
    1. Fernández-de-Las-Peñas C, Florencio LL, Plaza-Manzano G, Arias-Buría JL. Clinical reasoning behind non-pharmacological interventions for the Management of Headaches: a narrative literature review. Int J Environ Res Public Health. 2020;17:4126. doi: 10.3390/ijerph17114126.
    1. 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 Int J Headache. 2015;35:211–219. doi: 10.1177/0333102414535110.
    1. Calhoun AH, Ford S, Millen C, Finkel AG, Truong Y, Nie Y. The prevalence of neck pain in migraine. Headache. 2010;50:1273–1277. doi: 10.1111/j.1526-4610.2009.01608.x.
    1. Houle M, Marchand A-A, Descarreaux M. Can headache profile predict future disability: a cohort study. Clin J Pain. 2020;36:594–600. doi: 10.1097/AJP.0000000000000843.
    1. Bragatto MM, Bevilaqua-Grossi D, Benatto MT, Lodovichi SS, Pinheiro CF, Carvalho GF, et al. Is the presence of neck pain associated with more severe clinical presentation in patients with migraine? A cross-sectional study. Cephalalgia Int J Headache. 2019;39:1500–1508. doi: 10.1177/0333102419854061.
    1. Luedtke K, Starke W, May A. Musculoskeletal dysfunction in migraine patients. Cephalalgia Int J Headache. 2018;38:865–875. doi: 10.1177/0333102417716934.
    1. Benatto MT, Florencio LL, Bragatto MM, Lodovichi SS, Dach F, Bevilaqua-Grossi D. Extensor/flexor ratio of neck muscle strength and electromyographic activity of individuals with migraine: a cross-sectional study. Eur Spine J Off Publ Eur Spine Soc Eur Spinal Deform Soc Eur Sect Cerv Spine Res Soc. 2019;28:2311–2318. doi: 10.1007/s00586-019-06097-9.
    1. Madsen BK, Søgaard K, Andersen LL, Skotte J, Tornøe B, Jensen RH. Neck/shoulder function in tension-type headache patients and the effect of strength training. J Pain Res. 2018;11:445–454. doi: 10.2147/JPR.S146050.
    1. Jull G, Hall T. Cervical musculoskeletal dysfunction in headache: how should it be defined? Musculoskelet Sci Pract. 2018;38:148–150. doi: 10.1016/j.msksp.2018.09.012.
    1. Luedtke K, Boissonnault W, Caspersen N, Castien R, Chaibi A, Falla D, et al. International consensus on the most useful physical examination tests used by physiotherapists for patients with headache: a Delphi study. Man Ther. 2016;23:17–24. doi: 10.1016/j.math.2016.02.010.
    1. Liang Z, Galea O, Thomas L, Jull G, Treleaven J. 5 cervical musculoskeletal impairments in migraine and tension type headache: a systematic review and meta-analysis. Musculoskelet Sci Pract. 2019;42:67–83. doi: 10.1016/j.msksp.2019.04.007.
    1. Chaibi A, Tuchin PJ, Russell MB. Manual therapies for migraine: a systematic review. J Headache Pain. 2011;12:127–133. doi: 10.1007/s10194-011-0296-6.
    1. 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;59:532–542. doi: 10.1111/head.13501.
    1. Kamonseki DH, Lopes EP, van der Meer HA, Calixtre LB. Effectiveness of manual therapy in patients with tension-type headache. A systematic review and meta-analysis. Disabil Rehabil. 2020;12:1–10.
    1. Victoria Espí-López G, Arnal-Gómez A, Arbós-Berenguer T, González ÁAL, Vicente-Herrero T. Effectiveness of physical therapy in patients with tension-type headache: literature review. J Jpn Phys Ther Assoc Rigaku Ryoho. 2014;17:31–38. doi: 10.1298/jjpta.Vol17_005.
    1. Côté P, Yu H, Shearer HM, Randhawa K, Wong JJ, Mior S, et al. Non-pharmacological management of persistent headaches associated with neck pain: a clinical practice guideline from the Ontario protocol for traffic injury management (OPTIMa) collaboration. Eur J Pain Lond Engl. 2019;23:1051–1070. doi: 10.1002/ejp.1374.
    1. Fernandez M, Moore C, Tan J, Lian D, Nguyen J, Bacon A, et al. Spinal manipulation for the management of cervicogenic headache: a systematic review and meta-analysis. Eur J Pain Lond Engl. 2020;24:1687–1702. doi: 10.1002/ejp.1632.
    1. Watson DH, Drummond PD. Head pain referral during examination of the neck in migraine and tension-type headache. Headache. 2012;52:1226–1235. doi: 10.1111/j.1526-4610.2012.02169.x.
    1. Watson DH, Drummond PD. Cervical referral of head pain in migraineurs: effects on the nociceptive blink reflex. Headache. 2014;54:1035–1045. doi: 10.1111/head.12336.
    1. Castien R, De Hertogh W. A neuroscience perspective of physical treatment of headache and neck pain. Front Neurol. 2019;10:276. doi: 10.3389/fneur.2019.00276.
    1. Hing W, Hall T, Mulligan B. The Mulligan concept of manual therapy - 2nd edition 2019. 2019.
    1. Hall T, Chan HT, Christensen L, Odenthal B, Wells C, Robinson K. Efficacy of a C1-C2 self-sustained natural apophyseal glide (SNAG) in the management of cervicogenic headache. J Orthop Sports Phys Ther. 2007;37:100–107. doi: 10.2519/jospt.2007.2379.
    1. Satpute K, Bedekar N, Hall T. Headache symptom modification: the relevance of appropriate manual therapy assessment and management of a patient with features of migraine and cervicogenic headache - a case report. J Man Manip Ther. 2020;28:181–188. doi: 10.1080/10669817.2019.1662637.
    1. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Jull G, Zito G, Trott P, Potter H, Shirley D, Richardson C. Inter examiner reliability to detect painful upper cervical joint dysfunction. Aust J Physiother. 1997;43:125–129. doi: 10.1016/S0004-9514(14)60406-2.
    1. Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, et al. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine. 2002;27:1835–1843. doi: 10.1097/00007632-200209010-00004.
    1. Petersen SM. Articular and muscular impairments in cervicogenic headache: a case report. J Orthop Sports Phys Ther. 2003;33:21–30. doi: 10.2519/jospt.2003.33.1.21.
    1. Castien RF, van der Windt DAWM, Dekker J, Mutsaers B, Grooten A. Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: design of a randomised clinical trial. BMC Musculoskelet Disord. 2009;10:21. doi: 10.1186/1471-2474-10-21.
    1. Dunning JR, Butts R, Mourad F, Young I, Fernandez-De-Las Penãs C, Hagins M, et al. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016;17:64. doi: 10.1186/s12891-016-0912-3.
    1. Jull G, Amiri M, Bullock-Saxton J, Darnell R, Lander C. Cervical musculoskeletal impairment in frequent intermittent headache. Part 1: subjects with single headaches. Cephalalgia Int J Headache. 2007;27:793–802. doi: 10.1111/j.1468-2982.2007.01345.x.
    1. O’Leary S, Jull G, Kim M, Vicenzino B. Specificity in retraining craniocervical flexor muscle performance. J Orthop Sports Phys Ther. 2007;37:3–9. doi: 10.2519/jospt.2007.2237.
    1. Uthaikhup S, Assapun J, Watcharasaksilp K, Jull G. Effectiveness of physiotherapy for seniors with recurrent headaches associated with neck pain and dysfunction: a randomized controlled trial. Spine J Off J North Am Spine Soc. 2017;17:46–55. doi: 10.1016/j.spinee.2016.08.008.
    1. Mulligan B. Manual therapy: NAGS, SNAGS, MWMS Etc. Plane View Services Limited. 2010.
    1. Hall T, Robinson K. The flexion-rotation test and active cervical mobility--a comparative measurement study in cervicogenic headache. Man Ther. 2004;9:197–202. doi: 10.1016/j.math.2004.04.004.
    1. Niere K, Jerak A. Measurement of headache frequency, intensity and duration: comparison of patient report by questionnaire and headache diary. Physiother Res Int J Res Clin Phys Ther. 2004;9:149–156. doi: 10.1002/pri.318.
    1. Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res Int Z Rehabil Rev Int Rech Readaptation. 2008;31:165–169.
    1. Fernández-de-las-Peñas C, Madeleine P, Caminero AB, Cuadrado ML, Arendt-Nielsen L, Pareja JA. Generalized neck-shoulder hyperalgesia in chronic tension-type headache and unilateral migraine assessed by pressure pain sensitivity topographical maps of the trapezius muscle. Cephalalgia Int J Headache. 2010;30:77–86. doi: 10.1111/j.1468-2982.2009.01901.x.
    1. Castien RF, van der Wouden JC, De Hertogh W. Pressure pain thresholds over the cranio-cervical region in headache: a systematic review and meta-analysis. J Headache Pain. 2018;19:9. doi: 10.1186/s10194-018-0833-7.
    1. Vernon H, Lawson G. Development of the headache activities of daily living index: initial validity study. J Manip Physiol Ther. 2015;38:102–111. doi: 10.1016/j.jmpt.2014.12.002.
    1. Satpute KH, Parekh K, Hall TM. The C0-C2 axial rotation test - reliability and correlation with the flexion rotation test in people with cervicogenic headache and migraine. Musculoskelet Sci Pract. 2021;51:102286. doi: 10.1016/j.msksp.2020.102286.
    1. Reid SA, Rivett DA, Katekar MG, Callister R. Comparison of mulligan sustained natural apophyseal glides and Maitland mobilizations for treatment of cervicogenic dizziness: a randomized controlled trial. Phys Ther. 2014;94:466–476. doi: 10.2522/ptj.20120483.
    1. Park JT. Evaluation and treatment of cervicogenic headache: a case study using interventions of soft tissue, joint mobilization, and stabilization exercises. Orthop Phys Ther Pract. 2011;23:190–196.
    1. Nijs J, Van Houdenhove B, Oostendorp RAB. Recognition of central sensitization in patients with musculoskeletal pain: application of pain neurophysiology in manual therapy practice. Man Ther. 2010;15:135–141. doi: 10.1016/j.math.2009.12.001.
    1. Alkhawajah HA, Alshami AM. The effect of mobilization with movement on pain and function in patients with knee osteoarthritis: a randomized double-blind controlled trial. BMC Musculoskelet Disord. 2019;20:452. doi: 10.1186/s12891-019-2841-4.

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