Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model.

BACKGROUND: In the United States, osteopathic manipulative treatment (OMT), is a popular complementary physical health approach for the treatment of neuromusculoskeletal disorders. However, post-OMT adverse events (AEs) are poorly defined in terms of frequency, severity, and temporal evolution. To date, no benchmark for patient safety exists. To improve understanding in this field, we set out to model the landscape of patient harm after OMT. METHODS: We conducted a comprehensive search of all available primary clinical research studies reporting on the occurrence of post-OMT AEs in nonpregnant, adult outpatients treated by an osteopathic physician in the United States. The methodology of eligible studies was then reviewed to select those containing the minimum required dataset to model the post-OMT AEs. The minimum required dataset consisted of four model parameters: 'post-OMT interval', 'OMT encounters with post-OMT interval assessment', 'AEs preceded by an OMT encounter', and 'AE severity.' We used the dataset extracted from selected studies to calculate a patient safety benchmark defined as the incidence rate of AEs per 100 post-OMT interval-days. RESULTS: From 212 manuscripts that we identified, 118 primary clinical research studies were assessed for eligibility. A total of 23 studies met inclusion criteria for methodological review, of which 13 studies passed and were selected for modeling. Mild AEs were the most frequent, accounting for n = 161/165 (98%) of total AEs observed in the literature. The cumulative incidence of mild AEs was also significantly greater (P = 0.01) than both moderate and severe grades. The benchmark incidence rate was 1.0 AEs per 100 post-OMT interval-days. CONCLUSIONS: The majority of post-OMT AEs observed in the primary clinical literature were of mild severity. Modeling of the combined dataset on post-OMT AEs allowed for the derivation of a patient safety benchmark that, to date, has not been established in the field of osteopathic manipulative medicine. Additional research is needed to improve model resolution during the post-OMT period. This work conceptualized a model for identifying and grading post-OMT AEs, which should facilitate future comparisons between institutions in order to continually improve patient safety standards in the field of osteopathic manipulative medicine.

[Exploratory study on spinal musculoskeletal health of osteopathy students]. / Étude exploratoire de la santé musculo-squelettique du rachis d'étudiants en ostéopathie.

BACKGROUND: During their training, students in osteopathy regularly undergo spinal manipulation exercises. This exposes the students' spine to unskilled gestures performed by their colleagues learning spinal manipulation. Discomfort, muscle soreness or moderate pain following spinal manipulations lasting two or three days are commonly reported. In addition, some students may have ongoing spinal musculoskeletal disease (SMSD) during their studies. The purpose of this study was to evaluate the prevalence of SMSDs and their maximum intensity in a population of osteopathy students and to determine whether individual differences exist. METHOD: An exploratory cross-sectional study took place over three years. Data were collected by means of a self-administrated standardised questionnaire screening for MSD: the Nordic questionnaire. RESULTS: There were 733 exploitable questionnaires, giving an average response rate of 91.5%. Average prevalence of SMSD was 98.4% during the last 12 months. Average maximum intensity perceived was 6/10 and 45% of students experienced an intense SMSD (scored between 7 and 10/10). Variation of the maximum intensity of SMSD between "before osteopathy studies" and "the last 12 months" was 1.2/10. This variation was influenced by the number of days students were manipulated during a week (p<0.0001). On average, students underwent manipulation three days a week. CONCLUSION: This study confirms the important prevalence of SMSD among osteopathy students. This result led us to carry out a qualitative study for exploring students' conceptions in health and spinal manipulative practices.

Does Compression of the Fourth Ventricle Cause Preterm Labor? Analysis of Data From the PROMOTE Study.

BACKGROUND: The technique for the compression of the fourth ventricle (CV4) in the brain has been described as a method of reaching the physiologic centers that reside in its floor and of restoring optimal flow of the cerebrospinal fluid. However, a study published as an abstract in 1992 questioned whether CV4, when applied to pregnant women, could induce uterine contractions and possibly labor. OBJECTIVE: To further examine whether CV4 could induce uterine contractions and labor as part of the osteopathic manipulative treatment (OMT) protocol used in the Pregnancy Research in Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study. METHODS: Labor and delivery data collected during the PROMOTE study from 2007-2011 were analyzed. The PROMOTE study was funded by the National Institutes of Health and was a randomized controlled clinical trial that measured the primary outcomes of back-specific functioning and pain in pregnant women aged 18 to 34 years. Participants were randomly divided into 3 groups-usual obstetric care only, placebo ultrasound treatment plus usual obstetric care, and OMT plus usual obstetric care. Study participants were scheduled for 7 treatment visits. Presented data were gathered from labor and delivery records. RESULTS: Four hundred participants were included. No significant differences were identified between treatment groups for the development of high-risk status (P=.293) or preterm delivery (P=.673). Evaluation of high-risk status by preterm delivery for the groups also showed no significant differences between groups (P=.455). CONCLUSION: The application of CV4 as part of an OMT protocol during the third trimester caused neither a higher incidence of preterm labor nor the development of high-risk status.

Manipulative Therapies: What Works.

Manipulative therapies include osteopathic manipulative treatment and many other forms of manual therapies used to manage a variety of conditions in adults and children. Spinal manipulative therapy may provide short-term improvement in patients with acute or chronic low back pain, comparable with other standard treatments. When compared with oral analgesics, cervical manipulation and/or mobilization appears to provide better short-term pain relief and improved function in patients with neck pain. Manipulative therapies may be as effective as amitriptyline for treating migraine headaches and can reduce the frequency and intensity of pain. Although manipulative therapy is sometimes recommended to treat conditions in children (e.g., musculoskeletal problems, otitis media, respiratory conditions, infantile colic, allergies), there is supporting evidence only for reducing the length of hospital stay for preterm infants. Mild adverse events, such as muscle stiffness and soreness, occur in up to 50% of adults who undergo manipulative therapy. Although serious adverse events such as lumbar disk herniation, cauda equina syndrome, and vertebrobasilar injury are rare, they can cause significant disability or death. Given the limited proven benefits of manipulative therapies and small risk of serious adverse events, additional high-quality, adequately powered studies are needed before definitive recommendations can be made for treating many conditions.

Manipulation techniques for infant torticollis. / Manipulasjonsteknikker ved nakkeasymmetri hos spedbarn.

BACKGROUND: Professionals in fields including chiropractic, physiotherapy, manual therapy and osteopathy recommend manipulation techniques for the treatment of infant torticollis. This article summarises the research evaluating such treatment. MATERIAL AND METHOD: The article is based on a search in MEDLINE, EMBASE, CINAHL, Cochrane CENTRAL, AMED, PEDro, and the Index to Chiropractic Literature in August 2017. Controlled studies were included to assess efficacy, and observational studies to reveal the risk of harm. RESULTS: We reviewed 3 418 unique hits from the literature search. We included three randomised controlled studies on the efficacy of manual therapy or osteopathy and three observational studies on possible adverse effects. Two studies on manual therapy suggested that manipulation techniques do not have any greater effect on symmetry and motor outcomes than parental guidance, physiotherapy and home exercises. One study suggested that osteopathy may contribute to increased symmetry compared to placebo, but the clinical significance of this change is uncertain. Neither the three randomised studies nor a large patient series involving 695 infants found manipulation techniques to be associated with a risk of serious adverse events, but three patient histories demonstrated that manipulation techniques may cause harm if the observed asymmetry has serious underlying causes. INTERPRETATION: Manipulation techniques have not been shown to be efficacious in the treatment of infant torticollis, but the available evidence must be considered uncertain.

Craniosacral therapy for chronic pain: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVES: To systematically assess the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. METHODS: PubMed, Central, Scopus, PsycInfo and Cinahl were searched up to August 2018. Randomized controlled trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated for pain intensity and functional disability (primary outcomes) using Hedges' correction for small samples. Secondary outcomes included physical/mental quality of life, global improvement, and safety. Risk of bias was assessed using the Cochrane tool. RESULTS: Ten RCTs of 681 patients with neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included. CST showed greater post intervention effects on: pain intensity (SMD = -0.32, 95%CI = [- 0.61,-0.02]) and disability (SMD = -0.58, 95%CI = [- 0.92,-0.24]) compared to treatment as usual; on pain intensity (SMD = -0.63, 95%CI = [- 0.90,-0.37]) and disability (SMD = -0.54, 95%CI = [- 0.81,-0.28]) compared to manual/non-manual sham; and on pain intensity (SMD = -0.53, 95%CI = [- 0.89,-0.16]) and disability (SMD = -0.58, 95%CI = [- 0.95,-0.21]) compared to active manual treatments. At six months, CST showed greater effects on pain intensity (SMD = -0.59, 95%CI = [- 0.99,-0.19]) and disability (SMD = -0.53, 95%CI = [- 0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups. DISCUSSION: In patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain. PROTOCOL REGISTRATION AT PROSPERO: CRD42018111975.

Musculoskeletal Therapies: Osteopathic Manipulative Treatment.

Osteopathic manipulative treatment (OMT) is being used increasingly in the United States. OMT techniques can be categorized as direct, using an activating force to move tissue through range-of-motion barriers; indirect, disengaging dysfunctional body parts away from restrictive barriers; and combined techniques. Evidence supports the effectiveness of this therapy in management of musculoskeletal conditions, particularly for low back pain, but is limited for many other conditions. Physician opinion, patient reporting, and student attitudes about OMT primarily are positive, but rates of OMT use vary across different US regions. Adverse effects are rare but include cauda equina syndrome, lumbar disk herniation, fracture, and hematoma or hemorrhagic cyst. Contraindications to OMT primarily involve conditions that increase bleeding risk or compromise bone, tendon, ligament, or joint integrity. National organizations have issued recommendations and guidelines recommending OMT as a first-line noninvasive therapy for low back pain after self-care. OMT is covered by many health insurance companies and training is available for allopathic physicians. Patient referrals should be made to appropriately credentialed physicians after consideration of supporting evidence and patient interest.

The effect of a six-week osteopathic visceral manipulation in patients with non-specific chronic low back pain and functional constipation: study protocol for a randomized controlled trial.

BACKGROUND: The aim of the proposed study is to analyze the effect of a six-week osteopathic visceral manipulation (OVM) program on the flexion-relaxation phenomenon in individuals with non-specific chronic low back pain (LBP) and functional constipation. METHODS/DESIGN: An assessor-blinded, two-arm, randomized, placebo-controlled trial will be conducted. The sample will comprise 76 individuals with non-specific chronic LBP who have functional intestinal constipation, aged 18-65 years. The participants will be randomly allocated to two groups: (1) OVM and (2) sham OVM (SOVM). Evaluations will involve an interview, the Oswestry Disability Index, Fear-Avoidance Beliefs Questionnaire, functional constipation according to Rome III criteria, Biering-Sorensen test to normalize electromyographic (EMG) data, T12-L1 paraspinal level of the EMG signal during the flexion-relaxation phenomenon, 11-point numeric pain rating scale and fingertip-to-floor test. OVM and SOVM will be performed once per week for six weeks. Group 1 will receive OVM for 15 min and Group 2 will receive a sham visceral technique. Evaluations will be performed before and after the first session, after six weeks of treatment, and three months after randomization (follow-up). The findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05). The limitation of the study is that the therapist will not be blinded. DISCUSSION: This will be the first trial to analyze the clinical response and electromyographic signals during the flexion-relaxation phenomenon after OVM. TRIAL REGISTRATION: Brazilian Clinical Trial Registry, RBR-7sx8j3 . Registered on 26 October 2017.

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment.

CONTEXT: Although adverse events in various types of manual therapy have been previously investigated, little is known about the incidence and types of adverse events that occur after osteopathic manipulative treatment (OMT). OBJECTIVE: To estimate the incidence and characterize the types of adverse events that patients report after OMT and prior to leaving the office to increase the likelihood of identifying adverse events caused by OMT. METHODS: As part of a prospective study evaluating the use and effectiveness of OMT, patients assessed how they felt immediately after OMT compared with before OMT using a 5-point ordinal rating scale (much better, better, about the same, worse, much worse). For patients who indicated they felt their condition had changed, a follow-up, open-ended question asked them to describe how it had changed. Patients who felt worse or much worse were considered to have experienced an adverse event. Two reviewers independently coded the types of adverse events based on the descriptions provided by the patients. Generalized logistic regression models were used to calculate incidence rates and 95% CIs for the types of adverse events. These models were also used to calculate the ORs and 95% CIs for associations of adverse events with demographic characteristics and with individual OMT techniques after accounting for demographic characteristics. RESULTS: Immediately after OMT, 884 patients provided data at 1847 office visits (663 [76%] women; 794 [92%] identified as white; mean [SD] age, 51.8 [15.8] years). Patients reported they felt worse or much worse immediately after OMT at 45 office visits; the incidence rate for adverse events was 2.5% (95% CI, 1.3%-4.7%). Pain/discomfort was the most commonly identified type of adverse event (16 [0.9%]; 95% CI, 0.5%-1.6%). Insufficient information was provided to determine the type of adverse event at 20 office visits. Women reported adverse events more frequently than men (OR, 13.9; 95% CI, 1.7-115.6; P=.01). CONCLUSION: The incidence of adverse events immediately after OMT, most commonly pain/discomfort, was lower than previous reports from other manual medicine disciplines. Larger studies are needed to determine the incidence of serious adverse events and to assess adverse events that occur in the days following OMT.

Upper Limb Ischemia by Subclavian Artery Dissection after Osteopathic Manipulation.

We report the case of a young woman who experienced ischemia of upper limb after osteopathic manipulation. Duplex and computed tomography scan showed wall hematoma of the ostium of subclavian artery. The patient spontaneously recovered so that no surgery was necessary. Dissection of vertebral and carotid arteries has been reported after osteopathic manipulations. We report ischemia of upper limb secondary to dissection of subclavian artery. Arterial dissections associated with manipulation should be recorded in a register in order to assess more carefully the vascular risk that this method carries.

Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study.

BACKGROUND: Osteopathic manipulative treatment (OMT) of the sphenopalatine ganglion (SPG) is used empirically for the treatment of rhinitis and snoring and is thought to increase pharyngeal stability. This trial was designed to study the effects of this treatment on pharyngeal stability evaluated by critical closing pressure in obstructive sleep apnoea syndrome. METHODS: This single-centre, randomized, crossover, double-blind study compared active manipulation and sham manipulation of the SPG. Randomization was computer-generated. Patients each received one active manipulation and one sham manipulation at an interval of 21 days and were evaluated 30 min and 48 h after each session administered by a qualified osteopath. Neither the patients, nor the investigator performing the evaluations were informed about the order of the two techniques (double-blind). The primary endpoint was the percentage of responding patients presenting increased pharyngeal stability defined by a variation of critical closing pressure (Pcrit) of at least -4 cmH2O at 30 min. Secondary endpoints were the variation of Pcrit in absolute values, sleepiness and snoring. Others endpoints were lacrimation (Schirmer's test), induced pain, sensations experienced during OMT. RESULTS: Ten patients were included and nine (57 [50; 58] years, comprising 7 men, with an apnoea-hypopnoea index of 31.0 [25.5; 33.2]/h; (values are median [quartiles])) were analysed. Seven patients were analysed for the primary endpoint and nine patients were analysed for secondary endpoints. Five patients responded after active manipulation versus no patients after sham manipulation (p = 0.0209). Active manipulation induced more intense pain (p = 0.0089), increased lacrimation (ns) and more tactile, nociceptive and gustatory sensations (13 versus 1) compared to sham manipulation. No significant difference was observed for the other endpoints. CONCLUSIONS: Osteopathic manipulative treatment of the SPG may improve pharyngeal stability in obstructive sleep apnoea syndrome. This trial validates the feasibility of the randomized, controlled, double-blind methodology for evaluation of this osteopathic treatment. Studies on a larger sample size must specify the efficacy on the apnoea-hypopnoea index. TRIAL REGISTRATION: The study was retrospectively registered in the clinicaltrial.gov registry under reference NCT01193738 on 1st September 2010 (first inclusion May 19, 2010).

PROMOTE Study: Safety of Osteopathic Manipulative Treatment During the Third Trimester by Labor and Delivery Outcomes.

BACKGROUND: Few quality data exist on the safety of osteopathic manipulative treatment (OMT) during pregnancy. The Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was a randomized controlled clinical trial that studied the application of an OMT protocol to manage pain and dysfunction in pregnant patients during their third trimester. OBJECTIVE: To evaluate the safety of an OMT protocol applied during the third trimester of pregnancy by analyzing incidence of high-risk status and labor and delivery outcomes. METHODS: In the PROMOTE study, 400 pregnant patients were randomly assigned to 1 of 3 study groups: usual care plus OMT (OMT), usual care plus placebo ultrasound treatment (PUT), or usual care only (UCO). The incidence of high-risk status of participants and outcomes of labor and delivery, including length of labor, fever in mother during labor, operative vaginal delivery, conversion to cesarean delivery, need for forceps or vacuum device, need for episiotomy, incidence of perineal laceration, meconium-stained amniotic fluid, and infants' Apgar scores, were analyzed. RESULTS: Data from 380 participants were studied. High-risk status was less likely to develop in participants who received OMT (95% CI, 0.16-0.91; P=.03). The OMT protocol also did not increase risk of precipitous labor, operative vaginal delivery, conversion to cesarean delivery, need for forceps or vacuum device, need for episiotomy, incidence of perineal laceration, or meconium-stained amniotic fluid when compared with participants in the other 2 groups (P>.05). Of all other maternal outcomes examined, no difference was reported among the 3 treatment groups with the exception of incidence of prolonged labor in the OMT group. Participants receiving OMT had longer durations of labor than participants in the other groups (P=.002). CONCLUSION: These results suggest that the OMT protocol given during the third trimester of pregnancy as applied in the PROMOTE study is safe with regard to labor and delivery outcomes. The increased duration in labor in the OMT group needs further study. (ClinicalTrials.gov number NCT00426244).

Does visceral osteopathic treatment accelerate meconium passage in very low birth weight infants?- A prospective randomized controlled trial.

BACKGROUND: To determine whether the complementary approach of visceral manipulative osteopathic treatment accelerates complete meconium excretion and improves feeding tolerance in very low birth weight infants. METHODS: This study was a prospective, randomized, controlled trial in premature infants with a birth weight <1500 g and a gestational age <32 weeks who received a visceral osteopathic treatment 3 times during their first week of life or no treatment. RESULTS: Passage of the last meconium occurred after a median of 7.5 days (95% confidence interval: 6-9 days, n = 21) in the intervention group and after 6 days (95% confidence interval: 5-9 days, n = 20,) in the control group (p = 0.11). However, osteopathic treatment was associated with a 8 day longer time to full enteral feedings (p = 0.02), and a 34 day longer hospital stay (Median = 66 vs. 100 days i.e.; p=0.14). Osteopathic treatment was tolerated well and no adverse events were observed. CONCLUSIONS: Visceral osteopathic treatment of the abdomen did not accelerate meconium excretion in VLBW (very low birth weight)-infants. However infants in the osteopathic group had a longer time to full enteral feedings and a longer hospital stay, which could represent adverse effects. Based on our trial results, we cannot recommend visceral osteopathic techniques in VLBW-infants. TRIAL REGISTRATION: Clinical trials.gov: NCT02140710.

Postoperative singultus: an osteopathic approach.

Singultus, or hiccups, is a common medical condition. Despite exponential leaps in medicine, the pathophysiologic cause remains poorly defined. Persistent singultus has been associated with conditions such as pulmonary embolism and myocardial infarction. Singultus is also a well-known postoperative complication. The criterion standard of care for patients with singultus involves ruling out lethal pathologic causes, attempting physical stimulation with Valsava maneuvers or drinking water, and, if no relief has been achieved, administering drugs to ease the symptoms. The authors report a case of a man whose postoperative singultus was successfully managed with osteopathic manipulative treatment. This approach addresses many of the possible underlying neuromechanical causes of the aberrant reflex with minimal potential for adverse effects. Physicians should consider osteopathic manipulative treatment in the care of patients with singultus.

Onset of complications following cervical manipulation due to malpractice in osteopathic treatment: a case report.

The aim of this study is to correlate cervical disc herniation with manipulation performed by a non-physician osteopath on a patient complaining of neck pain. The authors report a case in which a woman - treated with osteopathic spinal manipulation - developed cervical-brachial neuralgia following the cervical disc herniation. The patient then underwent surgery and was followed by physiotherapists. A clinical condition characterized by limitation of neck mobility, with pain and sensory deficit in the right arm and II-III fingers, still persists. The patient consulted the authors to establish whether cervical disc herniation could be attributed to manipulation. Adverse events or side effects of spinal manipulative therapy are relatively common and usually benign. Most of these side effects are mild or moderate, but sometimes they can be severe. Cervical manipulation can provoke complications less often than thoracic or lumbar manipulation. Furthermore, many diseases can be absolutely and relatively contraindicated to osteopathic treatment. Therefore, the knowledge of a patient's clinical conditions is essential before starting a manipulative treatment; otherwise the osteopath could be accused of malpractice. It is the authors' opinion that a cause-effect relationship exists between the manipulative treatment and the development of disc herniation.

What puts the adverse in 'adverse events'? Patients' perceptions of post-treatment experiences in osteopathy--a qualitative study using focus groups.

Patients commonly report mild to moderate effects following all forms of manual therapy. These are often regarded as adverse events by practitioners but there is limited evidence on how patients view their post-treatment experiences, and what meaning they ascribe to them. This qualitative study used three focus group discussions (19 participants) to explore osteopathic patients' perspectives; a framework approach was used to analyse the data. There were four emergent themes (and 23 sub-themes). Interpretative (level two) analysis of the data led to a conceptual model of meaning with four inter-related components: Expectations; Personal investment; Osteopathic encounter; Clinical change, under an overarching construct, the 'global osteopathic experience'. These four components, designated EPOC, can have a profound impact on a patient's post-treatment experiences and their perception of what is adverse. This model suggests there is disparity between patient perceptions and clinical definitions of adverse events; awareness by practitioners of this disparity is essential for effective clinical management.