Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article II): a meta-analysis relating methods to trial results.

ABSTRACT: Sham interventions in randomized clinical trials (RCTs) of physical, psychological, and self-management (PPS) therapies for pain are highly variable in design and believed to contribute to poor internal validity. However, it has not been formally tested whether the extent to which sham controls resemble the treatment under investigation consistently affects trial outcomes, such as effect sizes, differential attrition, participant expectancy, and blinding effectiveness. Placebo- or sham-controlled RCTs of PPS interventions of clinical pain populations were searched in 12 databases. The similarity of control interventions to the experimental treatment was rated across 25 features. Meta-regression analyses assessed putative links between employed control interventions, observed effect sizes in pain-related outcomes, attrition, and blinding success. The sample included 198 unique control interventions, dominated by manual therapy and chronic musculoskeletal pain research. Meta-analyses indicated small-to-moderate benefits of active treatments over control interventions, across subgroups of manual therapies, exercise, and rehabilitation, and psychological intervention trials. Multiple meta-regression modelling demonstrated that similarity between sham control and tested interventions predicted variability in pain-related outcomes, attrition, and blinding effectiveness. Influential variables were differences relating to the extent of intervention exposure, participant experience, and treatment environments. The results support the supposed link between blinding methods and effect sizes, based on a large and systematically sourced overview of methods. However, challenges to effective blinding are complex and often difficult to discern from trial reports. Nonetheless, these insights have the potential to change trial design, conduct, and reporting and will inform guideline development.

Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods.

ABSTRACT: Blinding is challenging in randomised controlled trials of physical, psychological, and self-management therapies for pain, mainly because of their complex and participatory nature. To develop standards for the design, implementation, and reporting of control interventions in efficacy and mechanistic trials, a systematic overview of currently used sham interventions and other blinding methods was required. Twelve databases were searched for placebo or sham-controlled randomised clinical trials of physical, psychological, and self-management treatments in a clinical pain population. Screening and data extraction were performed in duplicate, and trial features, description of control methods, and their similarity to the active intervention under investigation were extracted (protocol registration ID: CRD42020206590). The review included 198 unique control interventions, published between 2008 and December 2021. Most trials studied people with chronic pain, and more than half were manual therapy trials. The described control interventions ranged from clearly modelled based on the active treatment to largely dissimilar control interventions. Similarity between control and active interventions was more frequent for certain aspects (eg, duration and frequency of treatments) than others (eg, physical treatment procedures and patient sensory experiences). We also provide an overview of additional, potentially useful methods to enhance blinding, as well as the reporting of processes involved in developing control interventions. A comprehensive picture of prevalent blinding methods is provided, including a detailed assessment of the resemblance between active and control interventions. These findings can inform future developments of control interventions in efficacy and mechanistic trials and best-practice recommendations.

The Role of Osteopathic Care in Gynaecology and Obstetrics: An Updated Systematic Review.

BACKGROUND: Many efforts are made to find safer and more feasible therapeutic strategies to improve gynaecological care. Non-pharmacological treatments, such as osteopathic interventions, could be used as complementary strategies to better manage different gynaecological conditions. This review aims to report the effectiveness of osteopathic treatment in the gynaecology and obstetrics field, updating the previous review published in 2016. The secondary aim was to elucidate the role of somatic dysfunction (SD) in osteopathic assessment and treatment procedures, as well as their health and economic implications. METHODS: An electronic search was conducted in the following databases: Embase, MEDLINE (PubMed), and Science direct. All types of clinical studies published between May 2014 and December 2021 have been included: randomised controlled trial (RCT), controlled before/after, interrupted time series quasi RCT, case controls, case reports, case series, observational, clinical studies involving any type of osteopathic treatment, (standardised, semi-standardised or patients' need-based treatment) performed alone or in combination with other treatments, were included). RESULTS: A total of 76,750 were identified through database searching and other sources. After the removal of duplicates, 47,655 papers were screened based on title and abstract. A total of 131 full-text articles were consequently assessed for eligibility. Twenty-one new articles were included in the synthesis. A total of 2632 participants with a mean age of 28.9 ± 10.5 years were included in the review. CONCLUSIONS: Results showed an effectiveness of osteopathic care in gynaecology and obstetrics, but the studies were too heterogeneous to perform quantitative analysis and make clinical recommendations. Nevertheless, osteopathic care could be considered a safe complementary approach to traditional gynaecological care.

Differences between experimental and placebo arms in manual therapy trials: a methodological review.

BACKGROUND: To measure the specific effectiveness of a given treatment in a randomised controlled trial, the intervention and control groups have to be similar in all factors not distinctive to the experimental treatment. The similarity of these non-specific factors can be defined as an equality assumption. The purpose of this review was to evaluate the equality assumptions in manual therapy trials. METHODS: Relevant studies were identified through the following databases: EMBASE, MEDLINE, SCOPUS, WEB OF SCIENCE, Scholar Google, clinicaltrial.gov, the Cochrane Library, chiloras/MANTIS, PubMed Europe, Allied and Complementary Medicine (AMED), Physiotherapy Evidence Database (PEDro) and Sciencedirect. Studies investigating the effect of any manual intervention compared to at least one type of manual control were included. Data extraction and qualitative assessment were carried out independently by four reviewers, and the summary of results was reported following the PRISMA statement. RESULT: Out of 108,903 retrieved studies, 311, enrolling a total of 17,308 patients, were included and divided into eight manual therapy trials categories. Equality assumption elements were grouped in three macro areas: patient-related, context-related and practitioner-related items. Results showed good quality in the reporting of context-related equality assumption items, potentially because largely included in pre-existent guidelines. There was a general lack of attention to the patient- and practitioner-related equality assumption items. CONCLUSION: Our results showed that the similarity between experimental and sham interventions is limited, affecting, therefore, the strength of the evidence. Based on the results, methodological aspects for planning future trials were discussed and recommendations to control for equality assumption were provided.

The role of touch in osteopathic practice: A narrative review and integrative hypothesis.

INTRODUCTION: Osteopathy relies on a touch-based approach to promote health. This narrative review aims to analyze the role of touch in clinical osteopathic practice. METHODS: A database search was conducted using MEDLINE, EMBASE, PEDro and Google Scholar. Peer-reviewed papers without specifying limits on dates and design were included. RESULTS: 47 articles met the inclusion criteria and were used to elucidate two main themes: Biological and psychological effects of touch; Touch in the context of osteopathic clinical reasoning. DISCUSSION: Touch is one of the tools to achieve a collaborative interaction with the patient, to substantiate clinical information, and to detect somatic dysfunctions: neuro-myofascial active areas that might act as an osteopath-patient interface to transmit the biological and physiological effects of touch. CONCLUSION: The findings of the review support a shared decision-making process, in which touch is one of the osteopath-patient dyad 's leading communication tools to develop a tailor-made osteopathic approach.

Osteopathy for primary headache patients: a systematic review.

OBJECTIVE: This systematic review aimed to assess the efficacy, effectiveness, safety, and tolerability of osteopathic manipulative treatment (OMT) in patients with headache. BACKGROUND: Migraine is one of the most common and disabling medical conditions. It affects more than 15% of the general population, causing high global socioeconomic costs, and the currently available treatment options are inadequate. METHODS: We systematically reviewed all available studies investigating the use of OMT in patients with migraine and other forms of headache. RESULTS: The search of literature produced six studies, five of which were eligible for review. The reviewed papers collectively support the notion that patients with migraine can benefit from OMT. OMT could most likely reduce the number of episodes per month as well as drug use. None of the included studies, however, was classified as low risk of bias according to the Cochrane Collaboration's tool for assessing risk of bias. CONCLUSION: The results from this systematic review show a preliminary low level of evidence that OMT is effective in the management of headache. However, studies with more rigorous designs and methodology are needed to strengthen this evidence. Moreover, this review suggests that new manual interventions for the treatment of acute migraine are available and developing.

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 in neurological diseases: Systematic review of the literature.

OBJECTIVE: The aim of the present systematic review is to critically evaluate the effectiveness of OMT as an adjuvant therapy in the management of patients with neurological diseases. METHODS: A systematic review was conducted and the findings were reported following the PRISMA statement. Twelve databases were searched for articles reporting the use of osteopathic manipulative treatment in neurological disorders. Each article was assessed using the Cochrane risk of bias tool and the Jadad score. RESULTS: 10 articles were included. OMT was used to test its efficacy and/or effectiveness in treating tension-type headache, migraine, cerebral palsy and gait analysis in patients affected by Parkinson's Disease. The general quality of the included trials ranged from very low, to low and moderate according to Cochrane standards. High heterogeneity between studies was found for the type of intervention, control and outcome measures used. CONCLUSION: Results showed that studies on the efficacy and/or effectiveness of OMT treatments are scarce, heterogeneous, and of low methodological quality. Further studies should be conducted including a more pragmatic methodology, an exhaustive description of all investigated and concurrent interventions, and a systematic report of adverse events, so as to obtain robust and generalizable results.

Osteopathic manipulative treatment in gynecology and obstetrics: A systematic review.

OBJECTIVE: The aim of the review was to evaluate the effects of the osteopathic manipulative treatment (OMT) on women with gynaecological and obstetric disorders. MATERIALS AND METHODS: An extensive search from inception to April 2014 was conducted on MEDLINE, Embase, the Cochrane library using MeSH and free terms. Clinical studies investigating the effect of OMT in gynaecologic and obstetric conditions were included as well as unpublished works. Reviews and personal contributions were excluded. Studies were screened for population, outcome, results and adverse effects by two independent reviewers using an ad-hoc data extraction form. The high heterogeneity of the studies led to a narrative review. RESULTS: 24 studies were included (total sample=1840), addressing back pain and low back functioning in pregnancy, pain and drug use during labor and delivery, infertility and subfertility, dysmenorrhea, symptoms of (peri)menopause and pelvic pain. Overall, OMT can be considered effective on pregnancy related back pain but uncertain in all other gynaecological and obstetrical conditions. Only three studies (12.5%) mentioned adverse events after OMT. CONCLUSIONS: Although positive effects were found, the heterogeneity of study designs, the low number of studies and the high risk of bias of included trials prevented any indication on the effect of osteopathic care. Further investigation with more pragmatic methodology, better and detailed description of interventions and systematic reporting of adverse events are recommended in order to obtain solid and generalizable results.

Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial.

CONTEXT: Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. OBJECTIVE: To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. METHODS: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. MAIN OUTCOMES MEASURES: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. RESULTS: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p < 0.001), expressed in normalized and absolute unit, and possibly decrease of sympathetic activity, as revealed by Low Frequency power (p < 0.01); results also showed a reduction of Low Frequency/High Frequency ratio (p < 0.001) and Detrended fluctuation scaling exponent (p < 0.05). CONCLUSIONS: Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.