Moderate to Substantial Inter-Rater Reliability in the Assessment of Cranial Bone Mobility Restrictions.

Background: The World Health Organization benchmarks for osteopathic training consider cranial osteopathy as an important manual skill. Studies of cranial manual therapy have exhibited poor reliability. The aim of this study was to investigate the inter-rater reliability of the manual mobility tests of the spheno-occipital synchondrosis (SOS), and the temporal, parietal, and frontal bones, as assessed in osteopathic manual therapy. Methods: Twenty-one adults were assessed on a single day by three experienced osteopaths using a standard assessment protocol. Before data collection, the osteopaths participated in a consensus training, which included establishing the criteria for identifying a cranial bone mobility restriction; the application of the seven-step palpation method; a pretesting practice; a fine-tuning palpation training; and a calibration period before the assessment of the subjects. Three subjects were assessed simultaneously with the evaluators rotating to assess each subject. The evaluators were blinded to the subject by a curtain, and each other's assessments. Each bone was rated as restricted or not restricted. The authors applied the Landis and Koch classification to describe the magnitude of inter-rater reliability. Results: Moderate reliability was established for a lateral strain of the SOS (Fleiss' generalized kappa 0.48), substantial reliability was established for the other SOS strain patterns (Fleiss' generalized kappa 0.62-0.75), and almost perfect reliability for temporal, parietal, and frontal bone (Fleiss' generalized kappa 0.81-0.96). Conclusion: The results demonstrate consistency when three experienced osteopaths evaluate cranial bone mobility restrictions. The results highlight the importance of consensus training and rigorous methodology in manual therapy reliability studies.

Evidence-based assessment of potential therapeutic effects of adjunct osteopathic medicine for multidisciplinary care of acute and convalescent COVID-19 patients.

Although the COVID-19 pandemic affects predominantly the respiratory function, epidemiological studies show that multiple systems can be affected. The severe complications of SARS-CoV-2 infection seem to be induced by an inflammatory dysregulation ("cytokine storm"), which can also induce an immunodepression. Several studies highlight beneficial effects of osteopathic medicine on inflammation and immune regulation. A careful review of evidence-based literature brings to the fore significant improvements of osteopathic manipulative treatment (OMT) in adjunction to conventional care. OMT can improve the condition of infected patients by decreasing symptoms and boosting the efficiency of conventional care. OMT might also benefit surviving patients by reducing the long-lasting consequences of the infection as well as improving their quality of life during convalescence. This review should constitute an argument in favor of multidisciplinary care, although further biological and clinical research is essential to better assess the potential beneficial contributions of adjunct osteopathic medicine to conventional care in the fight against pandemics such as COVID-19.

Assessment and Management of Somatic Dysfunctions in Patients With Patellofemoral Pain Syndrome.

CONTEXT: Patellofemoral pain syndrome (PFPS) is one of the most common determinants of knee pain. The causes of PFPS are multifactorial, and most treatment approaches are conservative. There are many kinds of therapy for this syndrome, which are based on building strength, flexibility, proprioception, and endurance. Training is functional and progression is gradual. Our hypothesis is that total-body osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) focused on the management of somatic dysfunctions could be useful for managing the pain of patients with PFPS. OBJECTIVE: To investigate the effect of OMTh on pain reduction in patients with PFPS. METHODS: This pilot study was randomized, controlled, and single-blinded with 2 months of follow-up. Qualified participants were randomly assigned to 1 of 2 groups: OMTh group or placebo group. Each participant received either 4 sessions of OMTh or 4 sessions of manual placebo intervention that consisted of passive touching without joint mobilization in a protocolled order. A visual analogue scale (VAS) was used to assess general knee pain, peripatellar pain, pain after prolonged sitting, pain during the patellar compression test, and pain during stair ascent and descent. Pain assessment was performed before the baseline (T0), second (T1), third (T2), and fourth (T3) sessions, and follow-up (T4) was performed 8 weeks after T3. RESULTS: Thirty-five participants were enrolled the study. The VAS score was significantly reduced and clinically relevant in the OMTh group after each treatment and after 2 months of follow-up. The change in the VAS score before each treatment indicates that the most improved areas at T1 compared with T0 were lumbar and sacral with improvements in 83% and 40% of patients, respectively. At T2 compared with T1, the most improved areas were cervical and sacral with improvements found in 58% and 36% of patients, respectively. The number of dysfunctions that were diagnosed decreased during the baseline to T3 period (40% change). The correlation analysis showed significant results for the dysfunction and the compression test at T2 (P=.01, ρ=0.543). CONCLUSION: Significant differences in VAS scores were found between the OMTh and placebo groups. These findings underline how OMTh can lead to reduced pain in patients with PFPS.

The Italian Osteopathic Practitioners Estimates and RAtes (OPERA) study: A cross sectional survey.

The prevalence of osteopathic practitioners, their professional profile and features of their clinical practice, particularly where statutory regulation does not yet exist, are still significantly underreported. The Osteopathic Practitioners Estimates and RAtes (OPERA) project was developed as an European-based census dedicated to profiling the osteopathic profession across Europe. The present study aimed to describe the osteopathic practitioners and the profession in Italy. A voluntary, online based, closed-ended survey was distributed across Italy in the period between February and June 2017. An e-based campaign was set up to reach the Italian osteopathic professionals. Participants were asked to complete the forms by filling in the information regarding the demographics, working status and professional activities, education, consultation fees, patient complaints, treatment and management. The survey was completed by 4816 individuals. 196 people started the survey but did not finish, which corresponds to a 4% attrition rate. The majority of respondents were males (66.7%). The modal age group was 30-39 (40.0%). 73.8% of respondents had a previous academic degree, mainly in the fields of sports science (36.4%) and physiotherapy (25.3%). 25.6% declared not to have a previous academic degree. The majority of respondents declared to work alone (58.4%), while the remaining declared to work in association with other professionals. The osteopaths /citizens ratio was 8.0 osteopaths/100,000 citizens. The profile of osteopaths in Italy seems to be characterised by a self-employed young adult male working mostly as a sole practitioner, who has been trained as osteopath through a part-time curriculum and had a previous degree mostly in the fields of sports science or physiotherapy. These results provide important insights into the osteopathic profession in Italy. The varied professional educational backgrounds need to be considered with regard to the implementation of a professional licensing process and future pre-registration education in the country. The number of respondents is an estimate of the actual number of Italian osteopaths. Only the completion of the regulatory process and the creation of the mandatory official register will allow to know the number of Italy based osteopaths.

Osteopathic manipulative treatment showed reduction of length of stay and costs in preterm infants: A systematic review and meta-analysis.

BACKGROUND: Osteopathic medicine is an emerging and complementary method used in neonatology. METHODS: Outcomes were the mean difference in length of stay (LOS) and costs between osteopathy and alternative treatment group. A comprehensive literature search of (quasi)- randomized controlled trials (RCTs), was conducted from journal inception to May, 2015. Eligible studies must have treated preterm infants directly in the crib or bed and Osteopathic Manipulative Treatment (OMT) must have been performed by osteopaths. A rigorous Cochrane-like method was used for study screening and selection, risk of bias assessment and data reporting. Fixed effect meta-analysis was performed to synthesize data. RESULTS: 5 trials enrolling 1306 infants met our inclusion criteria. Although the heterogeneity was moderate (I = 61%, P = 0.03), meta-analysis of all five studies showed that preterm infants treated with OMT had a significant reduction of LOS by 2.71 days (95% CI -3.99, -1.43; P < 0.001). Considering costs, meta-analysis showed reduction in the OMT group (-1,545.66&OV0556;, -1,888.03&OV0556;, -1,203.29&OV0556;, P < 0.0001). All studies reported no adverse events associated to OMT. Subgroup analysis showed that the benefit of OMT is inversely associated to gestational age. CONCLUSIONS: The present systematic review showed the clinical effectiveness of OMT on the reduction of LOS and costs in a large population of preterm infants.

Osteopathic manipulative treatment: A systematic review and critical appraisal of comparative effectiveness and health economics research.

In recent years, evidence has emerged regarding the effectiveness of osteopathic manipulative treatments (OMT). Despite growing evidence in this field, there is need for appropriate research designs that effectively reflect the person-centred system of care promoted in osteopathy and provide data which can inform policy decisions within the healthcare system. The purpose of this systematic review is to identify, appraise and synthesise the evidence from comparative effectiveness and economic evaluation research involving OMT. A database search was conducted using CINAHL, PubMed, PEDro, AMED, SCOPUS and OSTMED.DR, from their inception to May 2015. Two separate searches were undertaken to identify original research articles encompassing the economic evaluation and comparative effectiveness of OMT. Identified comparative effectives studies were evaluated using the Cochrane risk of bias tool and appraised using the Good Reporting of Comparative Effectiveness (GRACE) principles. Identified economic studies were assessed with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) guidelines. Sixteen studies reporting the findings of comparative effectiveness (n = 9) and economic evaluation (n = 7) research were included. The comparative effectiveness studies reported outcomes for varied health conditions and the majority (n = 6) demonstrated a high risk of bias. The economic evaluations included a range of analyses and considerable differences in the quality of reporting were evident. Despite some positive findings, published comparative effectiveness and health economic studies in OMT are of insufficient quality and quantity to inform policy and practice. High quality, well-designed, research that aligns with international best practice is greatly needed to build a pragmatic evidence base for OMT.

Osteopathic Manipulative Treatment in Pediatric and Neonatal Patients and Disorders: Clinical Considerations and Updated Review of the Existing Literature.

Osteopathic medicine is a form of complementary and alternative medicine. Osteopathic practitioners treat patients of all ages: according to the Osteopathic International Alliance's 2012 survey, about one-third of all treated patients are aged between 31 and 50 years and nearly a quarter (23.4%) are pediatric patients, with 8.7% of them being younger than 2 years. In 2013 a systematic review evaluated the effectiveness of osteopathic manipulative treatment (OMT) in pediatric patients with different underlying disorders, but due to the paucity and low methodological quality of the primary studies the results were inconclusive. The aim of this review is therefore to update the evidence concerning OMT in perinatal and pediatric disorders and to assess its clinical impact. Most published studies favor OMT, but the generally small sample sizes in these studies cannot support ultimate conclusions about the efficacy of osteopathic therapy in pediatric age. In turn, clinical trials of OMT in premature infants might represent an important step in the osteopathic research because they can address both cost-effectiveness issues, and an innovative, multidisciplinary approach to the management of specific pediatric diseases cared for by the same, common health care system. The available studies in neonatal settings provide evidence that OMT is effective in reducing the hospital length of stay of the treated infants, therefore, suggesting that robust cost-effectiveness analyses should be included in the future clinical trials' design to establish new possible OMT-shared strategies within the health care services provided to newborns.

Teaching and Assessment of High-Velocity, Low-Amplitude Techniques for the Spine in Predoctoral Medical Education.

Although national didactic criteria have been set for predoctoral education and assessment in osteopathic manipulative treatment, there is no criterion standard for teaching methods and assessments of osteopathic manipulative treatment competence in colleges of osteopathic medicine. This issue is more pressing with the creation of the single graduate medical education accreditation system by the American Osteopathic Association and Accreditation Council for Graduate Medical Education, which introduced the creation of "osteopathic recognition" for residencies that want to incorporate osteopathic principles and practice into their programs. Residencies with osteopathic recognition may include both osteopathic and allopathic graduates. Increased standardization at the predoctoral level, however, is recommended as osteopathic principles and practice training applications are expanded. The objectives of this article are to review the standards for teaching osteopathic medical students high-velocity, low-amplitude (HVLA) techniques for the spine; to review and discuss the methods used to assess medical students' proficiency in using HVLA; and to propose baseline standards for teaching and assessing HVLA techniques among medical students.

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

BACKGROUND: Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. MATERIALS AND METHODS: The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. RESULTS: A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. CONCLUSIONS: Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

Evaluation of knowledge of Oral Health of Community Health Agents connected with the Family Health Strategy / Avaliação do conhecimento em saúde bucal de agentes comunitários de saúde vinculados à Estratégia Saúde da Família

The aim of this study was to evaluate the knowledge of Community Health Agents (CHA) about the oral health/disease process, and compare the results between those who work in Family Health Teams (FHT), with and without Oral Health Teams (OHT). The participants in this study were 162 subjects, representing 66% of the total number of CHA in the municipality, and 81 of them are connected with Family Health Units (FHU) with OHT, and 81 CHS with FHUs without OHT. Data were collected from October to December 2013, by application of a questionnaire, containing personal and professional data, and 12 validated questions about knowledge of the oral health/disease process. The Mann-Whitney test was applied to verify differences between the groups. Statistically significant differences were verified between the groups of CHA when the total scores of questions about the oral health/disease process were analyzed (p < 0.0021). It was concluded that knowledge about the oral health/disease process, of the CHAs connected with a FHU with an OHT was better when compared with that of CHAs connected with a FHU without an OHT.

O objetivo deste estudo foi avaliar os conhecimentos de Agentes Comunitários de Saúde (ACS) sobre o processo saúde/doença bucal, comparando resultados entre os que atuam em Equipes de Saúde da Família (ESF), com e sem Equipes de Saúde Bucal (ESB). Participaram do estudo 162 sujeitos, representando 66% do total de ACS do município, sendo 81 deles vinculados à Unidade de Saúde da Família (USF) com ESB, e 81 ACS à USF sem ESB. Os dados foram coletados de outubro a dezembro de 2013, por meio da aplicação de um questionário contendo dados pessoais, profissionais e 12 questões validadas sobre conhecimentos do processo saúde-doença bucal. Foi aplicado o teste Mann-Whitney para verificar diferenças entre os grupos. Verificou-se que houve diferenças estatisticamente significativas entre os grupos de ACS, quando se analisou o total de escores das questões sobre o processo saúde-doença bucal (p < 0,0021). Conclui-se que os conhecimentos sobre processo saúde/doença bucal dos ACS vinculados à USF com ESB são melhores quando comparado aos ACS vinculados à USF sem ESB.

Prevention of progressive back-specific dysfunction during pregnancy: an assessment of osteopathic manual treatment based on Cochrane Back Review Group criteria.

CONTEXT: Back pain during pregnancy may be associated with deficits in physical functioning and disability. Research indicates that osteopathic manual treatment (OMT) slows the deterioration of back-specific functioning during pregnancy. OBJECTIVE: To measure the treatment effects of OMT in preventing progressive back-specific dysfunction during the third trimester of pregnancy using criteria established by the Cochrane Back Review Group. DESIGN: A randomized sham-controlled trial including 3 parallel treatment arms: usual obstetric care and OMT (UOBC+OMT), usual obstetric care and sham ultrasound therapy (UOBC+SUT), and usual obstetric care (UOBC). SETTING: The Osteopathic Research Center within the University of North Texas Health Science Center in Fort Worth. PARTICIPANTS: A total of 144 patients were randomly assigned and included in intention-to-treat analyses. MAIN OUTCOME MEASURES: Progressive back-specific dysfunction was defined as a 2-point or greater increase in the Roland-Morris Disability Questionnaire (RMDQ) score during the third trimester of pregnancy. Risk ratios (RRs) and 95% confidence intervals (CIs) were used to compare progressive back-specific dysfunction in patients assigned to UOBC+OMT relative to patients assigned to UOBC+SUT or UOBC. Numbers needed to treat (NNTs) and 95% CIs were also used to assess UOBC+OMT vs each comparator. Subgroup analyses were performed using median splits of baseline scores on a numerical rating scale for back pain and the RMDQ. RESULTS: Overall, 68 patients (47%) experienced progressive back-specific dysfunction during the third trimester of pregnancy. Patients who received UOBC+OMT were significantly less likely to experience progressive back-specific dysfunction (RR, 0.6; 95% CI, 0.3-1.0; P=.046 vs UOBC+SUT; and RR, 0.4; 95% CI, 0.2-0.7; P<.0001 vs UOBC). The effect sizes for UOBC+OMT vs UOBC+SUT and for UOBC+OMT vs UOBC were classified as medium and large, respectively. The corresponding NNTs for UOBC+OMT were 5.1 (95% CI, 2.7-282.2) vs UOBC+SUT; and 2.5 (95% CI, 1.8-4.9) vs UOBC. There was no statistically significant interaction between subgroups in response to OMT. CONCLUSION: Osteopathic manual treatment has medium to large treatment effects in preventing progressive back-specific dysfunction during the third trimester of pregnancy. The findings are potentially important with respect to direct health care expenditures and indirect costs of work disability during pregnancy.

Establishing the content validity of palpatory examination for the assessment of the lumbar spine using ultrasonography: a pilot study.

CONTEXT: Practitioners of manipulative medicine have long sought to prove the intra- and interexaminer reliability of palpatory examinations in assessing somatic dysfunction. However, decades of research have yet to achieve the level of reproducibility needed to satisfy evidence-based criteria. OBJECTIVES: To examine the content validity of segmental motion evaluations using ultrasonographic measurements and to investigate the implication of these results for understanding the effects of an osteopathic manipulative treatment technique--high-velocity, low-amplitude (HVLA)--applied to somatic dysfunction in the lumbar spine. METHODS: A repeated-measures design was used, with the ultrasonographer blinded to the findings for each participant. The study was divided into 2 phases: (1) palpatory and ultrasonographic examination with no treatment and (2) palpatory and ultrasonographic examination with HVLA treatment. During phase 1, measurements were taken of tissue depth corresponding to bony landmarks of the dysfunctional vertebrae. Dysfunction was identified by means of palpatory examination and captured in sequential (ie, test-retest) ultrasonographic images. Content validity of somatic dysfunction was addressed by comparing palpatory examination with ultrasonographic data. During phase 2, the same protocol for tissue depth measurements was applied to the pre- and posttreatment images for comparison. RESULTS: Twelve young, healthy, asymptomatic students with no contraindications to HVLA treatment were recruited at Kansas City University of Medicine and Biosciences. The test-retest reliability, as determined by a Pearson correlation coefficient, was 0.997. For all participants, objectively identified side of dysfunction correlated with palpatory evaluation of segmental motion. A within-subjects analysis of variance was performed on the raw data, corrected for lumbar lordosis, showing statistical significance for main effect for side of measurement (P<.001) and interaction of side and time (P<.001), and showed no statistically significant effect for time (P=.259). CONCLUSION: Ultrasonography is a reliable instrument for the assessment of somatic dysfunction of the lumbar spine. The data also establish the content validity of palpatory examinations. In addition, this study provides the first objective evidence, to our knowledge, of the effect of a thrusting manipulative treatment on dysfunctional lumbar vertebrae.

Assessment of the influence of osteopathic myofascial techniques on normalization of the vocal tract functions in patients with occupational dysphonia.

OBJECTIVES: Occupational voice disorders are accompanied by increased tension of the external laryngeal muscle which changes the position of the larynx and consequently disturbs the conditions of functioning of the vocal tract. The aim of the study is to assess the use of osteopathic procedures in the diagnosis and treatment of occupational dysphonia. MATERIAL AND METHODS: Study subjects included 40 teachers with chronic diseases of the voice organ (38 women and 2 men) aged from 39 to 59 (mean age: 48.25). Before and after the voice therapy the osteopathic examination according to Libermann's protocol was performed as well as phoniatric examination including laryngovideostroboscopy (LVSS), assessment of the maximum phonation time (MPT) and the Voice Handicap Index (VHI) score. The voice therapy, scheduled and supervised by a laryngologist-phoniatrician and conducted by a speech-language pathologist, was supplemented with osteopathic myofascial rehabilitation of the larynx. The chi-square McNemar test and non-parametric Wilcoxon matched pairs test were applied in the statistical assessment. RESULTS: The applied interdisciplinary treatment including osteopathic and vocal therapy resulted in a statistically significant decrease in tenderness of muscles raising the larynx (cricothyroid ligament, sternocleidomastoid muscles, and pharyngeal constrictor muscles) and in lowering the tonus (geniohyoid muscles, pharyngeal constrictor muscles and sternocleidomastoid muscles). A significant improvement was also observed in the case of dysfunction of the cricothyroid joint examined during glissando and yawning, as well as in asymmetry of the thyrohyoid apparatus. Moreover, the therapy resulted in significantly better normalization of the head position and better control of the centre of gravity of the body. Statistically significant post-therapy improvement was observed in the phoniatric examination, including VHI scores, MPT results and parameters of videostroboscopic examination. CONCLUSIONS: The use of osteopathic therapy helps significantly improve the functions of the vocal tract in patients with occupational dysphonia.

Can laypersons be trained to effectively deliver osteopathic manual therapy to patients with HIV?: a pilot study.

CONTEXT: Osteopathic manipulative treatment (OMT) may provide added benefits to standard human immunodeficiency virus (HIV) and AIDS treatments. However, lack of access to trained OMT providers is a potential barrier to the widespread use of OMT in the management of HIV and AIDS. OBJECTIVES: To determine the best time to measure the short-term impact of a brief OMT protocol on white blood cell counts in individuals with HIV and AIDS. Also, to explore recruiting and training laypersons to administer select osteopathic manual techniques. METHODS: Participants were HIV-positive men aged between 18 and 65 years who had not undergone antiretroviral therapy in the past 12 months, had CD4(+) lymphocyte counts of 200 to 700 cells/mm(3), and had viral load levels of less than 100,000 copies/mL. Participants were randomly assigned to an OMT group or a control group; those in the OMT group recruited a layperson for training in osteopathic manual therapy. Participants in the OMT group received a 15-minute OMT protocol consisting of myofascial release of the thoracic inlet, pectoral traction, rib raising, thoracic pump, and abdominal pump. Participants in the control group engaged in conversation with the researcher for 15 minutes. Between-group differences for each white blood cell type were examined at varying time intervals after the protocols. Laypersons were trained to administer thoracic and abdominal pump techniques. They were tested by multiple choice examinations and by an independent rater for fidelity of administration. RESULTS: Twenty-one participants met the eligibility criteria. Of those, 18 returned for their study visit (OMT group, n=9; control group, n=9). An optimal time interval for measurement of white blood cell changes across the 5 cell types was not determined. However, P values for the 30-minute interval were consistently below 0.18 for neutrophils, eosinophils, and monocytes. Nine laypersons were trained in osteopathic manual therapy, 5 of whom scored 100% on initial completion of the multiple-choice examination; the remaining 4 laypersons scored 80% on the first try and 100% on the second try. All laypersons appropriately administered the manual therapy protocol. CONCLUSION: It is feasible to recruit and train laypersons to administer selected osteopathic manual therapy techniques with fidelity. Longitudinal studies on this concept are needed to examine patient outcomes and to evaluate the retention and fidelity of laypersons over time.

Osteopathic evaluation and manipulative treatment in reducing the morbidity of otitis media: a pilot study.

OBJECTIVE: To study the effects of osteopathic manipulative treatment in routine pediatric care for children with recurrent acute otitis media. STUDY DESIGN: Pilot cohort study with 1-year posttreatment follow-up. At follow-up, subjects' parents or legal guardians and their referring and/or family physicians were contacted to determine recurrence of otitis media since intervention. SUBJECTS: A referred and volunteer sample of pediatric patients ranging in age from 7 months to 35 months with a history of recurrent otitis media (N=8). INTERVENTION: For 3 weeks, all subjects received weekly osteopathic structural examinations and osteopathic manipulative treatment. This intervention was performed concurrently with traditional medical management. RESULTS: Five (62.5%) subjects had no recurrence of symptoms. Of the three remaining subjects in this cohort, one had a bulging tympanic membrane, another had four episodes of otitis media, and the last underwent surgery after recurrence at 6 weeks posttreatment. Closer analysis of the posttreatment course of the last two subjects indicates that there may have been a clinically significant decrease in morbidity for a period of time after intervention. CONCLUSION: The present study indicates that osteopathic manipulative treatment may change the progression of recurrent otitis media, a finding that supports the need for additional research in this area.

A preliminary assessment of the impact of cranial osteopathy for the relief of infantile colic.

In this open, controlled, prospective study, 28 infants with colic were randomized to either cranial osteopathic manipulation or no treatment; all were seen once weekly for 4 weeks. Treatment was according to individual findings, and administered by the same practitioner. Parents recorded time spent crying, sleeping and being held/rocked on a 24-hour diary. A progressive, highly significant reduction between weeks 1 and 4 in crying (hours/24h) was detected (P<0.001) in treated infants; similarly, there was a significant improvement in time spent sleeping (P<0.002). By contrast, no significant differences were detected in these variables for the control group. Overall decline in crying was 63% and 23%, respectively, for treated and controls; improvement in sleeping was 11% and 2%. Treated infants also required less parental attention than the untreated group. In conclusion, this preliminary study suggests that cranial osteopathic treatment can benefit infants with colic; a larger, double-blind study is warranted.

Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care.

BACKGROUND: Spinal pain is common and frequently disabling. Management guidelines have encouraged referral from primary care for spinal manipulation. However, the evidence base for these recommendations is weak. More pragmatic trials and economic evaluations have been recommended. OBJECTIVES: Our aim was to assess the effectiveness and health care costs of a practice-based osteopathy clinic for subacute spinal pain. METHODS: A pragmatic randomized controlled trial was carried out in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. A total of 201 patients with neck or back pain of 2-12 weeks duration were allocated at random between usual GP care and an additional three sessions of osteopathic spinal manipulation. The primary outcome measure was the Extended Aberdeen Spine Pain Scale (EASPS). Secondary measures included SF-12, EuroQol and Short-form McGill Pain Questionnaire. Health care costs were estimated from the records of referring GPs. RESULTS: Outcomes improved more in the osteopathy group than the usual care group. At 2 months, this improvement was significantly greater in EASPS [95% confidence interval (CI) 0.7-9.8] and SF-12 mental score (95% CI 2.7-10.7). At 6 months, this difference was no longer significant for EASPS (95% CI -1.5 to 10.4), but remained significant for SF-12 mental score (95% CI 1.0-9.9). Mean health care costs attributed to spinal pain were significantly greater by 65 UK pounds in the osteopathy group (95% CI 32-155 UK pounds). Though osteopathy also cost 22 UK pounds more in mean total health care cost, this was not significant (95% CI - 159 to 142 UK pounds). CONCLUSION: A primary care osteopathy clinic improved short-term physical and longer term psychological outcomes, at little extra cost. Rigorous multicentre studies are now needed to assess the generalizability of this approach.