Evidence-Based Osteopathy for Tension-Type Headache (EBOTTH)

NCT02592850 | Withdrawn

• 2 other identifiers: EBOTTH-1203
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tension-type headache (TTH) is a very common primary headache disorder, with important costs for both patients and society. Often these patients are not willing to take prophylactic medications and resort to complementary therapies. Osteopathic manipulative treatment (OMT) is an interesting option in such field, since it is characterized by a low profile of side effects. In this study the investigators will assess the efficacy of OMT (semi-structured evaluation and "black box" treatment) in frequent Episodic TTH (ETTH) in an outpatient setting. Preliminary data for power calculation are already available (Rolle et al. 2014), and the investigators plan to recruit 264 ETHH patients by a multicentric, randomized, double-blind, sham-controlled design.

Conditions

Tension-Type Headache

Keywords

Osteopathic manipulative treatment; Frequent Episodic Tension-Type Headache; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Headache frequency

  average reduction of headache frequency between the two arms and/or over time obtained from the headache diary (n/month)

  4 months

Secondary Outcomes (5)

• Headache intensity

  4 months

• Symptomatic Drugs

  4 months

• Headache Disability Inventory (HDI)

  4 months

• Headache Impact Test-6 (HIT-6)

  4 months

• Side effects

  4 months

Other Outcomes (1)

• Goal Attainment Scale (GAS) for osteopathic dysfunction

  4 months

Study Arms (2)

Osteopathic Manipulative Treatment

EXPERIMENTAL

Active manipulative treatment.

Other: osteopathic manipulative treatment

Sham Osteopathic Manipulative Treatment

SHAM COMPARATOR

Sham manipulative treatment.

Other: sham

Interventions

osteopathic manipulative treatment OTHER

This intervention will not be protocol-based but the treating D.O. will compulsory have to include the evaluation (and possible treatment) of temporo-mandibular joint disorders and cervical dysfunctions (semi-structured treatment). Specifically, OMT will focus on correcting those osteopathic dysfunctions found during the initial evaluation; both structural (including myofascial release and HVLA), visceral and craniosacral techniques will be administered as appropriate. Duration: 45 minutes. Administered once a week for four weeks.

Also known as: OMT

Osteopathic Manipulative Treatment

sham OTHER

In this intervention, the operator will be restricted to the assessment of the cranial rhythmic impulse (CRI), temporo-mandibular joint disorders and cervical dysfunctions, spending a similar amount of time to that being spent on OMT-treated patients. Any found osteopathic dysfunction will not be corrected. Duration: 45 minutes. Administered once a week for four weeks.

Also known as: SHAM-OMT

Sham Osteopathic Manipulative Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 and ≤65 years-old,
• diagnosis of frequent episodic tension-type headache according to the International Headache Society guidelines,
• frequency of attacks ≥3/month,
• willing to adhere to study procedures,
• signed informed consent

You may not qualify if:

• age \<18 or \>65 years-old,
• headache duration less than one year,
• history of: major psychiatric disorders, relevant cognitive deficits, chronic pain other than headache, secondary headaches,
• any type of headache prophylactic treatment ongoing or started during the study,
• hormonal therapy started or modified during the study,
• participating to other clinical trials,
• not willing to sign informed consent

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Italian School of Osteopathy and Manual Therapies: collaborator
• Alpha Search Milano: collaborator

Related Publications (48)

• Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.

  PMID: 17381554 BACKGROUND

• Jensen R, Stovner LJ. Epidemiology and comorbidity of headache. Lancet Neurol. 2008 Apr;7(4):354-61. doi: 10.1016/S1474-4422(08)70062-0.

  PMID: 18339350 BACKGROUND

• Schwartz BS, Stewart WF, Simon D, Lipton RB. Epidemiology of tension-type headache. JAMA. 1998 Feb 4;279(5):381-3. doi: 10.1001/jama.279.5.381.

  PMID: 9459472 BACKGROUND

• Rasmussen BK, Jensen R, Schroll M, Olesen J. Epidemiology of headache in a general population--a prevalence study. J Clin Epidemiol. 1991;44(11):1147-57. doi: 10.1016/0895-4356(91)90147-2.

  PMID: 1941010 BACKGROUND

• Stovner LJ, Zwart JA, Hagen K, Terwindt GM, Pascual J. Epidemiology of headache in Europe. Eur J Neurol. 2006 Apr;13(4):333-45. doi: 10.1111/j.1468-1331.2006.01184.x.

  PMID: 16643310 BACKGROUND

• Stovner LJ, Hagen K. Prevalence, burden, and cost of headache disorders. Curr Opin Neurol. 2006 Jun;19(3):281-5. doi: 10.1097/01.wco.0000227039.16071.92.

  PMID: 16702836 BACKGROUND

• Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010 Aug;11(4):289-99. doi: 10.1007/s10194-010-0217-0. Epub 2010 May 16.

  PMID: 20473702 BACKGROUND

• Jensen R. Diagnosis, epidemiology, and impact of tension-type headache. Curr Pain Headache Rep. 2003 Dec;7(6):455-9. doi: 10.1007/s11916-003-0061-x.

  PMID: 14604504 BACKGROUND

• Holroyd KA, Stensland M, Lipchik GL, Hill KR, O'Donnell FS, Cordingley G. Psychosocial correlates and impact of chronic tension-type headaches. Headache. 2000 Jan;40(1):3-16. doi: 10.1046/j.1526-4610.2000.00001.x.

  PMID: 10759896 BACKGROUND

• Beghi E, Bussone G, D'Amico D, Cortelli P, Cevoli S, Manzoni GC, Torelli P, Tonini MC, Allais G, De Simone R, D'Onofrio F, Genco S, Moschiano F, Beghi M, Salvi S. Headache, anxiety and depressive disorders: the HADAS study. J Headache Pain. 2010 Apr;11(2):141-50. doi: 10.1007/s10194-010-0187-2. Epub 2010 Jan 27.

  PMID: 20108021 BACKGROUND

• Steiner TJ, Stovner LJ, Katsarava Z, Lainez JM, Lampl C, Lanteri-Minet M, Rastenyte D, Ruiz de la Torre E, Tassorelli C, Barre J, Andree C. The impact of headache in Europe: principal results of the Eurolight project. J Headache Pain. 2014 May 21;15(1):31. doi: 10.1186/1129-2377-15-31.

  PMID: 24884549 BACKGROUND

• Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.

  PMID: 23771276 BACKGROUND

• Lenaerts ME. Burden of tension-type headache. Curr Pain Headache Rep. 2006 Dec;10(6):459-62. doi: 10.1007/s11916-006-0078-z.

  PMID: 17087872 BACKGROUND

• 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.

  PMID: 22136117 BACKGROUND

• Bendtsen L, Jensen R. Treating tension-type headache -- an expert opinion. Expert Opin Pharmacother. 2011 May;12(7):1099-109. doi: 10.1517/14656566.2011.548806. Epub 2011 Jan 20.

  PMID: 21247362 BACKGROUND

• Bendtsen L, Jensen R. Tension-type headache. Neurol Clin. 2009 May;27(2):525-35. doi: 10.1016/j.ncl.2008.11.010.

  PMID: 19289230 BACKGROUND

• Fumal A, Schoenen J. Tension-type headache: current research and clinical management. Lancet Neurol. 2008 Jan;7(1):70-83. doi: 10.1016/S1474-4422(07)70325-3.

  PMID: 18093564 BACKGROUND

• Jensen R, Rasmussen BK. Burden of headache. Expert Rev Pharmacoecon Outcomes Res. 2004 Jun;4(3):353-9. doi: 10.1586/14737167.4.3.353.

  PMID: 19807317 BACKGROUND

• Barbanti P, Egeo G, Aurilia C, Fofi L. Treatment of tension-type headache: from old myths to modern concepts. Neurol Sci. 2014 May;35 Suppl 1:17-21. doi: 10.1007/s10072-014-1735-3.

  PMID: 24867829 BACKGROUND

• Mathew PG, Mathew T. Taking care of the challenging tension headache patient. Curr Pain Headache Rep. 2011 Dec;15(6):444-50. doi: 10.1007/s11916-011-0223-1.

  PMID: 21845469 BACKGROUND

• Rolle G, Tremolizzo L, Somalvico F, Ferrarese C, Bressan LC. Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache. J Am Osteopath Assoc. 2014 Sep;114(9):678-85. doi: 10.7556/jaoa.2014.136.

  PMID: 25170037 BACKGROUND

• Fernandez-de-Las-Penas C, Alonso-Blanco C, Cuadrado ML, Miangolarra JC, Barriga FJ, Pareja JA. Are manual therapies effective in reducing pain from tension-type headache?: a systematic review. Clin J Pain. 2006 Mar-Apr;22(3):278-85. doi: 10.1097/01.ajp.0000173017.64741.86.

  PMID: 16514329 BACKGROUND

• Fernandez-de-las-Penas C, Alonso-Blanco C, San-Roman J, Miangolarra-Page JC. Methodological quality of randomized controlled trials of spinal manipulation and mobilization in tension-type headache, migraine, and cervicogenic headache. J Orthop Sports Phys Ther. 2006 Mar;36(3):160-9. doi: 10.2519/jospt.2006.36.3.160.

  PMID: 16596892 BACKGROUND

• Tsao JC. Effectiveness of massage therapy for chronic, non-malignant pain: a review. Evid Based Complement Alternat Med. 2007 Jun;4(2):165-79. doi: 10.1093/ecam/nel109. Epub 2007 Feb 5.

  PMID: 17549233 BACKGROUND

• Lenssinck MB, Damen L, Verhagen AP, Berger MY, Passchier J, Koes BW. The effectiveness of physiotherapy and manipulation in patients with tension-type headache: a systematic review. Pain. 2004 Dec;112(3):381-388. doi: 10.1016/j.pain.2004.09.026.

  PMID: 15561394 BACKGROUND

• Astin JA, Ernst E. The effectiveness of spinal manipulation for the treatment of headache disorders: a systematic review of randomized clinical trials. Cephalalgia. 2002 Oct;22(8):617-23. doi: 10.1046/j.1468-2982.2002.00423.x.

  PMID: 12383058 BACKGROUND

• Fernandez-de-Las-Penas C. Physical therapy and exercise in headache. Cephalalgia. 2008 Jul;28 Suppl 1:36-8. doi: 10.1111/j.1468-2982.2008.01618.x.

  PMID: 18494995 BACKGROUND

• Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.

  PMID: 12221344 BACKGROUND

• Torelli P, Jensen R, Olesen J. Physiotherapy for tension-type headache: a controlled study. Cephalalgia. 2004 Jan;24(1):29-36. doi: 10.1111/j.1468-2982.2004.00633.x.

  PMID: 14687010 BACKGROUND

• Espi-Lopez GV, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, Benitez-Martinez JC, Lluch E, Falla D. Effect of manual therapy techniques on headache disability in patients with tension-type headache. Randomized controlled trial. Eur J Phys Rehabil Med. 2014 Dec;50(6):641-7. Epub 2014 Apr 30.

  PMID: 24785463 BACKGROUND

• Bronfort G, Assendelft WJ, Evans R, Haas M, Bouter L. Efficacy of spinal manipulation for chronic headache: a systematic review. J Manipulative Physiol Ther. 2001 Sep;24(7):457-66.

  PMID: 11562654 BACKGROUND

• Posadzki P, Ernst E. Spinal manipulations for tension-type headaches: a systematic review of randomized controlled trials. Complement Ther Med. 2012 Aug;20(4):232-9. doi: 10.1016/j.ctim.2011.12.001. Epub 2011 Dec 29.

  PMID: 22579436 BACKGROUND

• Sun-Edelstein C, Mauskop A. Complementary and alternative approaches to the treatment of tension-type headache. Curr Pain Headache Rep. 2008 Dec;12(6):447-50. doi: 10.1007/s11916-008-0076-4.

  PMID: 18973739 BACKGROUND

• Hoyt WH, Shaffer F, Bard DA, Benesler JS, Blankenhorn GD, Gray JH, Hartman WT, Hughes LC. Osteopathic manipulation in the treatment of muscle-contraction headache. J Am Osteopath Assoc. 1979 Jan;78(5):322-5. No abstract available.

  PMID: 581588 BACKGROUND

• Ajimsha MS. Effectiveness of direct vs indirect technique myofascial release in the management of tension-type headache. J Bodyw Mov Ther. 2011 Oct;15(4):431-5. doi: 10.1016/j.jbmt.2011.01.021. Epub 2011 Feb 11.

  PMID: 21943616 BACKGROUND

• Voigt K, Liebnitzky J, Burmeister U, Sihvonen-Riemenschneider H, Beck M, Voigt R, Bergmann A. Efficacy of osteopathic manipulative treatment of female patients with migraine: results of a randomized controlled trial. J Altern Complement Med. 2011 Mar;17(3):225-30. doi: 10.1089/acm.2009.0673. Epub 2011 Mar 8.

  PMID: 21385086 BACKGROUND

• Anderson RE, Seniscal C. A comparison of selected osteopathic treatment and relaxation for tension-type headaches. Headache. 2006 Sep;46(8):1273-80. doi: 10.1111/j.1526-4610.2006.00535.x.

  PMID: 16942472 BACKGROUND

• Rajendran D, Bright P, Bettles S, Carnes D, Mullinger B. What puts the adverse in 'adverse events'? Patients' perceptions of post-treatment experiences in osteopathy--a qualitative study using focus groups. Man Ther. 2012 Aug;17(4):305-11. doi: 10.1016/j.math.2012.02.011. Epub 2012 Mar 15.

  PMID: 22425134 BACKGROUND

• Tinel D, Bliznakova E, Juhel C, Gallien P, Brissot R. Vertebrobasilar ischemia after cervical spine manipulation: a case report. Ann Readapt Med Phys. 2008 Jun;51(5):403-14. doi: 10.1016/j.annrmp.2008.04.010. Epub 2008 May 28. English, French.

  PMID: 18586346 BACKGROUND

• Cicconi M, Mangiulli T, Bolino G. Onset of complications following cervical manipulation due to malpractice in osteopathic treatment: a case report. Med Sci Law. 2014 Oct;54(4):230-3. doi: 10.1177/0025802413513451. Epub 2014 Jan 8.

  PMID: 24402084 BACKGROUND

• Greenman PE, McPartland JM. Cranial findings and iatrogenesis from craniosacral manipulation in patients with traumatic brain syndrome. J Am Osteopath Assoc. 1995 Mar;95(3):182-8; 191-2.

  PMID: 7751168 BACKGROUND

• Suh SI, Koh SB, Choi EJ, Kim BJ, Park MK, Park KW, Yoon JS, Lee DH. Intracranial hypotension induced by cervical spine chiropractic manipulation. Spine (Phila Pa 1976). 2005 Jun 15;30(12):E340-2. doi: 10.1097/01.brs.0000166511.59868.b7.

  PMID: 15959358 BACKGROUND

• Hebert JJ, Stomski NJ, French SD, Rubinstein SM. Serious Adverse Events and Spinal Manipulative Therapy of the Low Back Region: A Systematic Review of Cases. J Manipulative Physiol Ther. 2015 Nov-Dec;38(9):677-691. doi: 10.1016/j.jmpt.2013.05.009. Epub 2013 Jun 17.

  PMID: 23787298 BACKGROUND

• Noll DR, Degenhardt BF, Stuart M, McGovern R, Matteson M. Effectiveness of a sham protocol and adverse effects in a clinical trial of osteopathic manipulative treatment in nursing home patients. J Am Osteopath Assoc. 2004 Mar;104(3):107-13. No abstract available.

  PMID: 15083985 BACKGROUND

• Vautravers P, Maigne JY. Cervical spine manipulation and the precautionary principle. Joint Bone Spine. 2000;67(4):272-6.

  PMID: 10963073 BACKGROUND

• Vautravers P, Maigne JY. [Cervical spine manipulation: risks--benefit--assessment]. Rev Neurol (Paris). 2003 Nov;159(11):1064-6. French.

  PMID: 14710030 BACKGROUND

• Murphy DR, Hurwitz EL, Gregory AA. Manipulation in the presence of cervical spinal cord compression: a case series. J Manipulative Physiol Ther. 2006 Mar-Apr;29(3):236-44. doi: 10.1016/j.jmpt.2006.01.001.

  PMID: 16584950 BACKGROUND

• Cagnie B, Barbaix E, Vinck E, D'Herde K, Cambier D. A case of abnormal findings in the course of the vertebral artery associated with an ossified hyoid apparatus. A contraindication for manipulation of the cervical spine? J Manipulative Physiol Ther. 2005 Jun;28(5):346-51. doi: 10.1016/j.jmpt.2005.04.007.

  PMID: 15965410 BACKGROUND

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Manipulation, Osteopathic; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Lucio Tremolizzo, MD, PhD

  University of Milano-Bicocca, Italy

  PRINCIPAL INVESTIGATOR

• Guido Rolle, DO, MD

  Italian School of Osteopathy and Manual Therapies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: October 30, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 4, 2018

Record last verified: 2018-05