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Brief Report  |   June 2017
Effects of Osteopathic Manipulative Therapy on Pain and Mood Disorders in Patients With High-Frequency Migraine
Author Notes
  • From Post-Coma Unit and Headache Centre, Istituto di Ricovero e Cura a Carattere Scientifico Fondazione Santa Lucia, Rome, Italy (Ms D'Ippolito and Dr Buzzi); Department of Psychology, La Sapienza University of Rome, Italy (Ms D'Ippolito); and Istituto di Ricovero e Cura a Carattere Scientifico, Fondazione Santa Lucia, Rome, Italy (Mr Tramontano). 
  • Financial Disclosures: None reported. 
  • Support: None reported. 
  •  *Address correspondence to Marco Tramontano, DO (Italy), Istituto di Ricovero Cura a Carattere Scientifico, Fondazione Santa Lucia, Via Ardeatina 306, 00179 Rome, Italy. E-mail: m.tramontano@hsantalucia.it
     
Article Information
Neuromusculoskeletal Disorders / Osteopathic Manipulative Treatment / Pain Management/Palliative Care / Psychiatry / Headache
Brief Report   |   June 2017
Effects of Osteopathic Manipulative Therapy on Pain and Mood Disorders in Patients With High-Frequency Migraine
The Journal of the American Osteopathic Association, June 2017, Vol. 117, 365-369. doi:10.7556/jaoa.2017.074
The Journal of the American Osteopathic Association, June 2017, Vol. 117, 365-369. doi:10.7556/jaoa.2017.074
Web of Science® Times Cited: 4
Abstract

Context: The substantial functional impairment associated with migraine has both physical and emotional ramifications. Mood disorders are often comorbid in patients with migraine and are known to adversely affect migraine activity.

Objectives: To explore the effects of osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) on pain and mood disorders in patients with high-frequency migraine.

Methods: Retrospective review of the medical records of patients with high-frequency migraine who were treated with OMTh at the Headache Istituto di Ricovero e Cura a Carattere Scientifico Fondazione Santa Lucia from 2011 to 2015. Clinical assessments were made using the Headache Disability Inventory (HDI), the Headache Impact Test (HIT-6), the Hamilton Depression Rating Scale (HDRS), and the State-Trait Anxiety Inventory (STAI) forms X-1 and X-2.

Results: Medical records of 11 patients (6 women; mean age, 47.5 [7.8] years) with a diagnosis of high-frequency migraine who participated in an OMTh program met the inclusion criteria and were included in the study. When the questionnaire scores obtained at the first visit (T0) and after 4 OMTh sessions (T1) were compared, significant improvement in scores were observed on STAI X-2 (T0: 43.18 [2.47]; T1: 39.45 [2.52]; P<.05), HIT-6 (T0: 63 [2.20]; T1: 56.27 [2.24]; P<.05), and HDI (T0: 58.72 [6.75]; T1: 45.09 [7.01]; P<.05).

Conclusion: This preliminary study revealed that patients with high-frequency migraine and comorbid mood disorders showed significant improvement after four 45-minute OMTh sessions. Further investigation into the effects of OMTh on pain and mood disorders in patients with high-frequency migraine is needed.

Primary headache disorders are common and heterogeneous. According to the International Classification of Headache Disorders 3-beta (ICHD-3b), they are classified as migraine, tension-type headache, and trigeminal autonomic cephalalgia.1 These headache disorders are characterized by episodic or chronic pain that cannot be attributed to an organic cause and are probably caused by complex neurobiologic phenomena involving the activation of diverse neurochemical and cellular signalling pathways in multiple regions of the brain.2 Migraine attacks are often accompanied by nausea, vomiting, photophobia, and phonophobia,1 which have a significant impact on activities of daily living; substantial functional impairment (ictal burden) has both physical and emotional ramifications.3 Migraines can also cause impairment between attacks (interictal burden), such as anxiety, anticipation of the next attack, and avoidance of activities because of fear of migraine or headache. Patients with migraines report reduced health-related quality of life, even during pain-free periods,4,5 characterized by impairment in work, school, family, and social life, difficulty making plans or commitments, and emotional/affective and cognitive distress.6 
Although many patients with primary headache disorders do not have clinically significant psychopathologic conditions, a large body of literature indicates that patients with migraine are 2 to 5 times more likely to have a diagnosis of a depressive or anxiety disorder.7,8 The Axis I psychiatric disorders most linked to migraine and headache (eg, major depression, anxiety disorders, phobias) have been studied more frequently than the Axis II personality disorders (eg, histrionic personality disorder, obsessive-compulsive personality disorder), even though they have been reported to occur in 26% of patients with chronic headache.7,8 Furthermore, psychiatric disorders are identified as factors influencing the progression of migraine from episodic to chronic forms.9 The psychological impact of headache on patients should not be underestimated. To help patients progressively manage the frequency and duration of their attacks, it is important to make them aware of factors such as dysfunctional emotions and thoughts, as well as maladaptive behaviors that can increase or aggravate migraines. 
As an alternative to traditional pharmacologic treatments used to manage headache disorders, nonpharmacologic treatment options may be preferred by some patients. Osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) is used to manage an array of diseases and conditions,10 especially musculoskeletal problems; therefore, it could be a valuable nonpharmacologic tool for treating patients with migraines, frequent episodic headaches, or chronic tension-type headaches.11 Several studies reported the efficacy of OMTh and other adjunctive therapies in reducing pain and medication overuse associated with postoperative pain and migraine.12-19 Pistoia et al20 reported that a combination of pharmacologic and nonpharmacologic treatments is the most effective approach. They found that the highest level of care was reached when pharmacologic interventions were integrated with other treatments, including physical and behavioral therapies. 
The aim of this preliminary study was to explore the effects of OMTh on pain and mood disorders in patients with a diagnosis of high-frequency migraine. 
Methods
We reviewed the medical records of patients with diagnosis of high-frequency migraine who were admitted to the Outpatient Headache Centre of IRCCS Fondazione Santa Lucia from 2011 to 2015. The inclusion criteria were as follows: (1) diagnosis according to the ICHD-3b (>8 and <15 days per month); (2) participation in the OMTh program; and (3) psychological evaluation before and after the OMTh program. We excluded the medical records of patients who showed 1 of the following exclusion criteria: (1) other ICHD-3b diagnosis (eg, tension-type headache, chronic migraine) or somatic or psychiatric disorders (eg, major depression, psychosis) and (2) presence of musculoskeletal disorders, temporomandibular disorders, or neurologic and rheumatic diseases. 
All patients studied had been admitted to the Outpatient Headache Centre with a diagnosis of high-frequency or chronic headaches. Patients underwent psychological evaluation to collect information on psychological symptoms or behavioral disturbances that are often present in patients with migraine. The standard psychological assessments our facility uses for evaluating depressive and anxiety symptoms and personality patterns include the Hamilton Depression Rating Scale (HDRS),21 the State-Trait Anxiety Inventory (STAI)22 forms X-1 and X-2, and the Millon Clinical Multiaxial Inventory (MCMI-III),23 which is administered only at the first visit. The Headache Disability Inventory (HDI)24 and the Headache Impact Test (HIT-6) are used to evaluate pain and its impact on activities of daily living.25 All patients are given the chance to be treated with OMTh, but only those willing to be treated are enrolled in the OMTh program. 
One osteopathic practitioner (M.T.), a member of the Italian Register of Osteopaths, carried out the OMTh. Four 45-minute sessions were provided over 8 weeks. The techniques were focused on correcting the dysfunctions found during the first evaluation and were performed using myofascial techniques, balanced ligamentous tension, and osteopathy in the cranial field.26,27 Tissue alteration, asymmetry, range of motion, and tenderness parameters were the criteria considered for osteopathic evaluation and treatment. After the OMTh program, all patients were reevaluated using HDRS, STAI X-1 and X-2, HDI, and HIT-6 to investigate differences before and after OMTh. 
This retrospective study was approved by the local ethics committee of Istituto di Ricovero e Cura a Carattere Scientifico Fondazione Santa Lucia. 
Statistical Analysis
Given the small sample size and the clinical scales used for data collection, we performed nonparametric analyses. Data collected before OMTh (T0) and after OMTh (T1) were analyzed with the Wilcoxon matched pairs test for nonparametric data using time as a variable (T0 vs T1). Differences were considered statistically significant at P≤.05. STATISTICA 8.0 software was used (Dell). 
Results
The medical records of 11 patients (6 women; mean [SD] age, 47.5 [7.8] years) with diagnosis of high-frequency migraine were included in the study. All patients continued their pharmacologic migraine prophylaxis treatment without any variation during the OMTh program and were asked to continue to avoid or reduce exposure to precipitating factors for the 2 months of the program. Although the number of migraine attacks per month was reduced from 10.45 (1.63) at T0 to 9.36 (0.92) at T1 (P<.001), this finding was not considered clinically meaningful because the sample was limited, and all patients remained in the same range of headache attacks (>8 and <15 days per month). 
The T0 and T1 questionnaire scores showed statistically significant decreases in mean scores: STAI X-2 (T0: 43.18 [2.47]; T1: 39.45 [2.52]; P<.05) HIT-6 (T0: 63 [2.20]; T1: 56.27 [2.24]; P<.05) and HDI (T0: 58.72 [6.75]; T1: 45.09 [7.01]; P<.05) (Table). The results observed in our small sample of patients showed that OMTh reduced the HIT-6 scores from a severe impact at T1 (mean [SD] 63 [2.20]) to a substantial impact at T2 (56.27 [2.24]). The change in the STAI X-2 mean score would not generally be considered clinically meaningful because the STAI X-2 T0 and T1 scores both suggested moderate anxiety. The HDI score showed a statistically significant difference between T0 and T1, but because a 29-point change or greater is considered a “clinically significant improvement,”24 the observed change in the HDI score cannot be considered clinically meaningful. We did not observe statistically significant changes in HDRS and STAI X-1 mean scores from T0 to T1. Regarding MCMI-III, mean scores between 75 and 84 are taken to indicate a major personality or mental health concern, and scores of 85 or higher indicate a persistent, more severe mental health concern or personality disorder. The MCMI-III scores in our sample revealed that 3 patients scored above 85 on the narcissistic personality trait and 3 others on the compulsive personality trait. 
Table.
Mean Scale Scores of Patients With High-Frequency Headaches Before (T0) and After (T1) Osteopathic Manipulative Therapya
Outcome Measures Score, Mean (SD)
T0 T1
HDI 58.72 (6.75) 45.09 (7.01)b
HIT-6 63 (2.20) 56.27 (2.24)b
STAI X-1 46.45 (3.47) 44.09 (2.35)
STAI X-2 43.18 (2.47) 39.45 (2.52)b
HDRS 11.45 (1.41) 10.63 (1.38)
No. of migraine attacks/mo 10.45 (1.63) 9.36 (0.92)

a Manipulative care provided by foreign-trained osteopaths. Four 45-minute sessions were provided over 8 weeks.b  P<.05.

Abbreviations: HDI, Headache Disability Inventory; HDRS, Hamilton Depression Rating Scale; HIT-6, Headache Impact Test-6; STAI, State-Trait Anxiety Inventory; T0, before treatment; T1, after four 45-minute sessions.

Table.
Mean Scale Scores of Patients With High-Frequency Headaches Before (T0) and After (T1) Osteopathic Manipulative Therapya
Outcome Measures Score, Mean (SD)
T0 T1
HDI 58.72 (6.75) 45.09 (7.01)b
HIT-6 63 (2.20) 56.27 (2.24)b
STAI X-1 46.45 (3.47) 44.09 (2.35)
STAI X-2 43.18 (2.47) 39.45 (2.52)b
HDRS 11.45 (1.41) 10.63 (1.38)
No. of migraine attacks/mo 10.45 (1.63) 9.36 (0.92)

a Manipulative care provided by foreign-trained osteopaths. Four 45-minute sessions were provided over 8 weeks.b  P<.05.

Abbreviations: HDI, Headache Disability Inventory; HDRS, Hamilton Depression Rating Scale; HIT-6, Headache Impact Test-6; STAI, State-Trait Anxiety Inventory; T0, before treatment; T1, after four 45-minute sessions.

×
Discussion
This retrospective study revealed that patients with high-frequency migraine had statistically significant decreases in scores on HIT-6, STAI X-2, and HDI after the OMTh program. Nevertheless, given the small number of patients and the biases inherent with retrospective studies, it is impossible to draw definitive conclusions about the causal association between OMTh and the score changes and the clinical meaning of these changes. 
The STAI X-2 is used to identify relatively stable individual differences in trait anxiety, which is a personality disposition describing a person's tendency to perceive situations as threatening. Many studies have shown that under stressful and nonstressful testing conditions, trait scores remain relatively stable, whereas STAI X-1 scores show a significant change in the expected direction.28,29 This finding might suggest that the score change in the STAI from T0 to T1 in the current study was a result of OMTh and not a natural variation of current state of anxiety. 
The presence of narcissistic and compulsive traits in some patients indicates that personality traits should be evaluated to better address multidisciplinary approaches. 
This study was conducted with several constraints. The retrospective, nonrandomized selection process is one limitation. The small sample size, owing to the strict inclusion and exclusion criteria, is another limitation, but it allowed for obtaining a homogenous group of patients. Our selection method necessarily resulted in a selection bias. The small sample size limited both the generalizability of findings to larger patient populations and the possibility of determining the clinical meaningfulness of score changes. Another limitation is the lack of a control group. The presence of a control group might have mitigated potential confounding factors, such as the mechanism of action of therapeutic touch and the attentive interaction between the clinician and the patient, which, in turn, could have positive effects on headache.30 Other confounding factors could be patient expectations or personality, which can succumb to a placebo effect.31 
This preliminary study would be useful for planning a prospective study, allowing for redefining inclusion and exclusion criteria and for computing an adequate sample size on the basis of our results. 
Conclusion
These findings lend preliminary support to our hypothesis that OMTh may have therapeutic effects on pain and mood disorders in patients with high-frequency migraine and may be useful as part of a multidisciplinary treatment program.32 The improvement in psychological factors, which are recognized to increase pain and influence the progression of migraine from episodic to chronic forms, may be particularly important. 
Acknowledgment
We thank the Centre for Osteopathic Medicine Collaboration for its support in reviewing the paper and Alex Martino Cinnera, PT, for his support in data analysis. 
References
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33(9):629-808. doi: 10.1177/0333102413485658 [CrossRef] [PubMed]
Charles A, Brennan KC. The neurobiology of migraine. Handb Clin Neurol. 2010;97:99-108. doi: 10.1016/S0072-9752(10)97007-3 [PubMed]
Leonardi M, Steiner TJ, Scher AT, Lipton RB. The global burden of migraine: measuring disability in headache disorders with WHO's Classification of Functioning, Disability and Health (ICF). J Headache Pain. 2005;6(6):429-440. doi: 10.1007/s10194-005-0252-4 [CrossRef] [PubMed]
Dahlof CG, Dimenas E. Migraine patients experience poorer subjective well-being/quality of life even between attacks. Cephalalgia. 1995;15(1):31-36. doi: 10.1046/j.1468-2982.1995.1501031.x [CrossRef] [PubMed]
Buse DC, Rupnow MF, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009;84(5):422-435. doi: 10.1016/S0025-6196(11)60561-2 [CrossRef] [PubMed]
Peres MF, Mercante JP, Guendler VZ, et al Cephalalgiaphobia: a possible specific phobia of illness. J Headache Pain. 2007;8(1):56-59. doi: 10.1007/s10194-007-0361-3 [CrossRef] [PubMed]
Moskowitz MA, Buzzi MG. Migraine general aspects. Handb Clin Neurol. 2010;97:253-266. doi: 10.1016/S0072-9752(10)97021-8 [PubMed]
Lake AEIII, Rains JC, Penzien DB, Lipchik GL. Headache and psychiatric comorbidity: historical context, clinical implications, and research relevance. Headache. 2005;45:493-506. doi: 10.1111/j.1526-4610.2005.05101.x [CrossRef] [PubMed]
Bigal ME, Lipton RB. Modifiable risk factors for migraine progression. Headache. 2006;46(9):1334-1343. doi: 10.1111/j.1526-4610.2006.00577.x [CrossRef] [PubMed]
Roberti di Sarsina P, Iseppato I. Non-Conventional medicine in Italy: the present situation. Eur J Integrative Med. 2009;1(2):65-71. doi: 10.1016/j.eujim.2009.04.002 [CrossRef]
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;114(9):678-685. doi: 10.7556/jaoa.2014.136 [CrossRef] [PubMed]
Nicholas AS, Oleski SL. Osteopathic manipulative treatment for postoperative pain. J Am Osteopath Assoc. 2002;102(9 suppl 3):S5-S8. [PubMed]
Cerritelli F, Ginevri L, Messi G, et al Clinical effectiveness of osteopathic treatment in chronic migraine: 3-armed randomized controlled trial. Complement Ther Med. 2015;23(2):149-156. doi: 10.1016/j.ctim.2015.01.011 [CrossRef] [PubMed]
Voigt K, Liebnitzky J, Burmeister U, et al Efficacy of osteopathic manipulative treatment of female patients with migraine: results of a randomized controlled trial. J Altern Complement Med. 2011;17(3):225-230. doi: 10.1089/acm.2009.0673 [CrossRef] [PubMed]
Mueller LL. Diagnosing and managing migraine headache. J Am Osteopath Assoc. 2007;107(10 suppl 6):ES10-ES6. [PubMed]
Cerritelli F, Ruffini N, Lacorte E, Vanacore N. Osteopathic manipulative treatment in neurological diseases: systematic review of the literature. J Neurol Sci. 2016;369:333-341. doi: 10.1016/j.jns.2016.08.062 [CrossRef] [PubMed]
Alexander J. Resolution of new daily persistent headache after osteopathic manipulative treatment. J Am Osteopath Assoc. 2016;116(3):182-185. doi: 10.7556/jaoa.2016.035 [CrossRef] [PubMed]
Gallagher RM. Headache pain. J Am Osteopath Assoc. 2005;105(9 suppl 4):S7-S11. [PubMed]
Keays AC, Neher JO, Safranek S, Webb CW. Clinical inquiries. Is osteopathic manipulation effective for headaches? J Fam Pract. 2008;57(3):190-191. [PubMed]
Pistoia F, Sacco S, Carolei A. Behavioral therapy for chronic migraine. Curr Pain Headache Rep. 2013;17(1):304. doi: 10.1007/s11916-012-0304-9 [CrossRef] [PubMed]
Hamilton M. A rating scale for depression. J Neurol, Neurosurg Psychiatry. 1960;23: 56-62. [CrossRef]
Spielberger CD, Gorsuch RL, Lushene RE. Test Manual for the State Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1970.
Zennaro A, Ferracuti S, Lang M, Sanavio E. Una Rivoluzione nell'Assessment Clinico Della Personalità. Adattamento Italiano del Test: Millon Clinical Multiaxial Inventory III. Firenze, Italy: Giunti OS; 2008.
Jacobson GP, Ramadan NM, Aggarwal SK, Newman CW. The Henry Ford Hospital headache disability inventory (HDI). Neurology. 1994;44(5):837-842. [CrossRef] [PubMed]
Bayliss M, Batenhorst A. The HIT-6™: A User's Guide. Lincoln, RI: QualityMetric, Inc; 2002.
Magoun H. Osteopathy in the Cranial Field. Kirksville, MO: Journal Printing Co; 1976.
Ward RC, executive ed. Foundations for Osteopathic Medicine. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2002.
Kendall PC, Finch AJ, Auerbach SM, Hooke JF, Mikulka PJ. State-Trait Anxiety Inventory: systematic evaluation. J Consult Clin Psychol. 1976;44(3):406-412. [CrossRef] [PubMed]
Rule WR, Traver MD. Test-retest reliabilities of State-Trait Anxiety Inventory in a stressful social analogue situation. J Pers Assess. 1983;47(3):276-277. doi: 10.1207/s15327752jpa4703_8 [CrossRef] [PubMed]
Keller E, Bzdek VM. Effects of therapeutic touch on tension headache pain. Nurs Res. 1986;35(2):101-106. [PubMed]
Autret A, Valade D, Debiais S. Placebo and other psychological interactions in headache treatment. J Headache Pain. 2012;13(3):191-198. doi: 10.1007/s10194-012-0422-0 [CrossRef] [PubMed]
Krause SJ, Stillman MJ, Tepper DE, Zajac D. A prospective cohort study of outpatient interdisciplinary rehabilitation of chronic headache patients. Headache. 2017;57(3):428-440. doi: 10.1111/head.13020 [CrossRef] [PubMed]
Table.
Mean Scale Scores of Patients With High-Frequency Headaches Before (T0) and After (T1) Osteopathic Manipulative Therapya
Outcome Measures Score, Mean (SD)
T0 T1
HDI 58.72 (6.75) 45.09 (7.01)b
HIT-6 63 (2.20) 56.27 (2.24)b
STAI X-1 46.45 (3.47) 44.09 (2.35)
STAI X-2 43.18 (2.47) 39.45 (2.52)b
HDRS 11.45 (1.41) 10.63 (1.38)
No. of migraine attacks/mo 10.45 (1.63) 9.36 (0.92)

a Manipulative care provided by foreign-trained osteopaths. Four 45-minute sessions were provided over 8 weeks.b  P<.05.

Abbreviations: HDI, Headache Disability Inventory; HDRS, Hamilton Depression Rating Scale; HIT-6, Headache Impact Test-6; STAI, State-Trait Anxiety Inventory; T0, before treatment; T1, after four 45-minute sessions.

Table.
Mean Scale Scores of Patients With High-Frequency Headaches Before (T0) and After (T1) Osteopathic Manipulative Therapya
Outcome Measures Score, Mean (SD)
T0 T1
HDI 58.72 (6.75) 45.09 (7.01)b
HIT-6 63 (2.20) 56.27 (2.24)b
STAI X-1 46.45 (3.47) 44.09 (2.35)
STAI X-2 43.18 (2.47) 39.45 (2.52)b
HDRS 11.45 (1.41) 10.63 (1.38)
No. of migraine attacks/mo 10.45 (1.63) 9.36 (0.92)

a Manipulative care provided by foreign-trained osteopaths. Four 45-minute sessions were provided over 8 weeks.b  P<.05.

Abbreviations: HDI, Headache Disability Inventory; HDRS, Hamilton Depression Rating Scale; HIT-6, Headache Impact Test-6; STAI, State-Trait Anxiety Inventory; T0, before treatment; T1, after four 45-minute sessions.

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