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

NCT ID: NCT02592850

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

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.

Detailed Description

Background:

Primary headache disorders are very common throughout the world, producing widespread and substantial disability and representing a concrete public-health priority. Tension-type headache (TTH) is the most common type of primary headache disorder, with a lifetime prevalence in the general population ranging between 30% and 78% in different studies. In general, headache is a chronic disorder with episodic manifestations that may range from few attacks/year up to daily episodes. Its impact on individuals' lives is greater than has generally been realized, including psychiatric, psychological and social correlates. The impact on patients can be very high, including ictal symptom burden, interictal burden, cumulative burden and impact on other people. The individual burden of TTH includes both symptoms occurring during the attacks (pain, eventually accompanied by no more than one of phonophobia or photophobia, according to International Classification of Headache Disorders) and elements of interictal burden, such as anxiety, mood disorders, affective distress and avoidance behavior. While present, symptoms may cause debility and prostration, and reduce functional ability. Even if patients with TTH generally are not unable to work, effectiveness and productivity may be consistently reduced. This secondary disability is quite significant because headache in general is most common in people between their teens and 50-60 years of age, the productive years. The elements of interictal burden, instead, may continuously affect wellbeing and impair quality of life. Moreover, TTH has a substantial impact on the health system, due to both direct and indirect financial cost. The high prevalence of TTH, considering its individual impact and huge financial costs, has important implications for health policy, since it is a source of high but potentially reducible socioeconomic burden. Essentially, TTH management is a public-health priority.

On the clinical side, tension-type headache has been defined as a multifactorial disorder, conceivably implying the need for tailored treatment strategies. Headache-related disability can usually be reduced by identifying and avoiding triggers combined with pharmacologic and non-pharmacologic treatment (such as relaxation and stress management techniques or physical therapies), but effective treatment modalities are still lacking. Particularly, symptomatic drugs are effective for episodes of TTH, whereas preventive treatment (indicated for frequent and chronic TTH) is, on average, barely effective, and do not display good tolerability. Patients are turning to complementary or alternative therapies for headaches, including osteopathic manipulative therapy (OMTh). One previous pilot study carried out by the investigators has suggested an efficacy for OMTh in frequent episodic TTH, that might represent an alternative treatment strategy to prophylactic drugs. Frequent episodic TTH (ETTH) was chosen for this study since it is the most common diagnostic category with indications for prophylactic drug management. To date there is no rigorously tested evidence that manual therapies in general have a positive effect on TTH, as many reviewers have found. Conflicting results in previous studies might be due both to the low number of clinical trials and an indiscriminate application of different techniques. Some studies, however, have demonstrated positive effects of manipulative therapy.

A systematic review found spinal manipulative therapy as effective as commonly used first-line prophylactic medications for both TTH and migraine headaches, but the Authors emphasized that their conclusions were based on only a few trials, raising the question of whether their analysis was methodologically adequate. A more recent systematic review concluded that spinal manipulation might alleviate TTH but that the small quantity of available data prevented any definitive conclusions. The combination of physical therapies with medications, can also increase the success of the treatment, particularly in case of comorbid mood disorders and unremitting headaches, as previously suggested. Although results of these and others published studies suggest positive effects, OMTh has rarely been rigorously tested for the care of patients with headache in general.

OMTh is not free of costs but is plausibly characterized by fewer contraindications and adverse events than conventional pharmacological treatments, and particularly indicated for patients not compliant with drug regimens and those at increased risk of adverse drug effects. Notably, there is disparity between patient perceptions and clinical definitions of adverse events, as a conceptual model with four inter-related components (expectation, personal investment, osteopathic encounter and clinical change) has suggested. Patients might report mild effects following OMTh and in general all forms of manual therapy, but these effects should not be strictly regarded as adverse events. Our previous pilot trial did not observe adverse events among ETTH patients belonging to both arms of the study (treatment and sham). Exceedingly rare serious adverse events may be observed after spine manipulation, only one of many different techniques usually administered in osteopathic clinical field and recommendations have been already published to meet the requirements of the principles of prevention and precaution. For example, minor unwanted effects of prior manipulation should be searched routinely and taken as contraindication for future spinal manipulations. Great care should be taken when particular anatomic conditions such as cord encroachment or increased vertebra-basilar risk are present. Certainly, besides effectiveness, still to be completely proven, the financial impact of OMTh on subjects and health systems could be also a topic of appraisal for future comparative studies.

However, considering all the exposed priorities in this field, the investigators decided to firstly address in a RCT the question of OMTh efficacy versus OMTh-sham treatment in ETTH.

Aims:

This is a protocol for a randomized controlled trial (RCT) exploring the efficacy of OMTh in ETTH with respect to OMTh-sham treatment by a single blinded multicenter design.

If OMTh effectiveness could be demonstrated in these patients, two putative repercussions in ETTH management might be expected: (a) increased compliance; (b) lower rate of side effects. Furthermore, OMTh would increase the range of available strategies for managing ETTH in clinical practice, perhaps even as an add-on therapy.

Study Design:

This is a multi-centre, double-blinded, randomized, sham-treatment (SHAM)-controlled study using an experimental design.

Presumed ETTH patients will be screened at pre-selected primary care settings (general practitioners), and the diagnosis of TTH reviewed (time -30, or T-30) by a neurologist that will ask patients to complete the headache diary for 30 days before randomization. Diaries will be reviewed at time 0 (T0; baseline) by a blind-rater D.O. that will decide if the number of attacks is compatible with the diagnosis of ETTH, allowing randomization. The blind-rater will perform an osteopathic structural examination that will compulsory include (semi-structured evaluation) also the assessment of temporo-mandibular joint disorders and cervical dysfunctions (TMJD and CD) in order to define putative goals of OMT that will be used for scoring a Goal Attainment Scale (GAS, see below Outcomes) without involving the treating D.O. that will operate independently. Furthermore, patients will be asked to complete the Headache Disability Inventory (HDI) and the Headache Impact Test-6 (HIT-6).

Randomization will be performed by the coordinating centre (Univ. of Milano-Bicocca, Italy) by randomly pre-generated lists; the coordinating centre, without informing the blind-rater, will communicate to the local Osteopathic Clinic these details. Patients will be given instructions to start treatment (OMT vs. SHAM in blind) that will be administered by a treating D.O. unblinded to treatment allocation. Patients will receive 4 weekly treatments completing the headache diary along the whole study (up to T120). The blind-rater will review diaries relative to the each previous period and ask patients to complete the HDI/HIT-6 at 30 days (T30, end of treatment), 60 days (T60, follow-up-1), 90 days (T90, follow-up-2) and 120 days (T120, end of study) with respect to randomization (T0). An osteopathic structural examination will be performed again at T120 (end of study) for GAS scoring. A central database will be filled.

Inclusion criteria will be: (1) a diagnosis of ETTH according to current International Headache Society guidelines; (2) willing to comply with the RCT procedures.

Exclusion criteria will be: (1) patients under 18 or over 65 years of age; (2) use during the previous three months of drugs for acute headache on ten or more days per month; (3) duration of disease less than one year; (4) history of major psychiatric diseases, significant cognitive disorders, significant chronic pain other than headache, or in general from a secondary headache; (5) any kind of ongoing prophylactic treatment or taking place during the whole study period; (6) estroprogestinic therapy started or modified during the whole study period.

Patients will be blindly allocated to (A) an experimental arm (OMT) and (B) a control arm (SHAM), i.e., manual perceptive technique without correction of any observed osteopathic disorder. In order to minimize the perceived differences, both groups will undergo to osteopathic structural examination, with a similar amount of time being spent on each session. OMT will not be protocol-based but the treating D.O. will compulsory have to include the evaluation (and possible treatment) of TMJD and CD (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. As regards the sham treatment, the operator will be restricted to the assessment of the cranial rhythmic impulse (CRI) in patients, spending a similar amount of time to that being spent on OMT-treated patients.

Primary outcome will be the change at T120 in patient-reported headache frequency of at least 30% with respect to the control group (based on the previous pilot study, Rolle et al. 2014). Secondary outcomes will include: (a) any significant reduction over time or with respect to the control group of the average headache intensity based on a scale between 0 (absence of pain) and 5 (worst perceived pain) (considered more sensible with respect to a 0-to-3 scale, see Rolle et al. 2014); (b) any significant reduction over time or with respect to the control group of the over-the-counter medication usage; (c) any significant reduction over time or with respect to the control group of the HDI/HIT-6 scores; (d) any significant reduction over time or with respect to the control group in patient-reported headache frequency. Tertiary outcome will be: any significant reduction over time or with respect to the control group of the blind-rater evaluation of the osteopathic effects of the whole treatment with respect to the attainments he initially proposed. This score will be assessed purely in terms of correction of those osteopathic dysfunctions that were detected at T0, by using the GAS, with a five-point score ranging from: -2 (much less than expected outcome), to -1 (less than expected outcome), to 0 (expected outcome reached), to +1 (greater than expected outcome), to +2 (much greater than expected outcome).

Finally, side effects will be recorded at each visit. Patients will be instructed to immediately report serious adverse effects.

Conditions

Tension-Type Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Osteopathic Manipulative Treatment

Active manipulative treatment.

Group Type: EXPERIMENTAL

osteopathic manipulative treatment

Intervention Type: 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.

Sham Osteopathic Manipulative Treatment

Sham manipulative treatment.

Group Type: SHAM_COMPARATOR

sham

Intervention Type: 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.

Interventions

osteopathic manipulative treatment

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.

Intervention Type: OTHER

sham

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.

Intervention Type: OTHER

Other Intervention Names

OMT; SHAM-OMT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Italian School of Osteopathy and Manual Therapies

OTHER

Sponsor Role: collaborator

Alpha Search Milano

UNKNOWN

Sponsor Role: collaborator

University of Milano Bicocca

OTHER

Sponsor Role: lead

Responsible Party

Tremolizzo Lucio

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucio Tremolizzo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Milano-Bicocca, Italy

Guido Rolle, DO, MD

Role: STUDY_DIRECTOR

Italian School of Osteopathy and Manual Therapies

References

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.

Reference Type: BACKGROUND

PMID: 17381554 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18339350 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9459472 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1941010 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16643310 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16702836 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20473702 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14604504 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10759896 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20108021 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24884549 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23771276 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 17087872 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22136117 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21247362 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 19289230 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18093564 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19807317 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24867829 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21845469 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25170037 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16514329 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16596892 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17549233 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15561394 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12383058 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18494995 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12221344 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14687010 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24785463 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11562654 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22579436 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18973739 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 581588 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21943616 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21385086 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16942472 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22425134 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18586346 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24402084 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7751168 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15959358 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23787298 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15083985 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 10963073 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 14710030 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16584950 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15965410 (View on PubMed)

Other Identifiers

203

Identifier Type: REGISTRY

Identifier Source: secondary_id

EBOTTH-1

Identifier Type: -

Identifier Source: org_study_id