The effects of osteopathic manipulative treatment on pain and disability in patients with chronic low back pain: a single-blinded randomized controlled trial.

CONTEXT: The evidence for the efficacy of osteopathic manipulative treatment (OMT) in the management of low back pain (LBP) is considered weak by systematic reviews, because it is generally based on low-quality studies. Consequently, there is a need for more randomized controlled trials (RCTs) with a low risk of bias. OBJECTIVES: The objective of this study is to evaluate the efficacy of an OMT intervention for reducing pain and disability in patients with chronic LBP. METHODS: A single-blinded, crossover, RCT was conducted at a university-based health system. Participants were adults, 21-65 years old, with nonspecific LBP. Eligible participants (n=80) were randomized to two trial arms: an immediate OMT intervention group and a delayed OMT (waiting period) group. The intervention consisted of three to four OMT sessions over 4-6 weeks, after which the participants switched (crossed-over) groups. The primary clinical outcomes were average pain, current pain, Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v1.0 pain interference and physical function, and modified Oswestry Disability Index (ODI). Secondary outcomes included the remaining PROMIS health domains and the Fear Avoidance Beliefs Questionnaire (FABQ). These measures were taken at baseline (T0), after one OMT session (T1), at the crossover point (T2), and at the end of the trial (T3). Due to the carryover effects of OMT intervention, only the outcomes obtained prior to T2 were evaluated utilizing mixed-effects models and after adjusting for baseline values. RESULTS: Totals of 35 and 36 participants with chronic LBP were available for the analysis at T1 in the immediate OMT and waiting period groups, respectively, whereas 31 and 33 participants were available for the analysis at T2 in the immediate OMT and waiting period groups, respectively. After one session of OMT (T1), the analysis showed a significant reduction in the secondary outcomes of sleep disturbance and anxiety compared to the waiting period group. Following the entire intervention period (T2), the immediate OMT group demonstrated a significantly better average pain outcome. The effect size was a 0.8 standard deviation (SD), rendering the reduction in pain clinically significant. Further, the improvement in anxiety remained statistically significant. No study-related serious adverse events (AEs) were reported. CONCLUSIONS: OMT intervention is safe and effective in reducing pain along with improving sleep and anxiety profiles in patients with chronic LBP.

The effects of osteopathic manipulative treatment on pain and disability in patients with chronic neck pain: A single-blinded randomized controlled trial.

BACKGROUND: Neck pain (NP) affects up to 70% of individuals at some point in their lives. Systematic reviews indicate that manual treatments can be moderately effective in the management of chronic, nonspecific NP. However, there is a paucity of studies specifically evaluating the efficacy of osteopathic manipulative treatment (OMT). OBJECTIVE: To evaluate the efficacy of OMT in reducing pain and disability in patients with chronic NP. DESIGN: Single-blinded, cross-over, randomized-controlled trial. SETTING: University-based, osteopathic manipulative medicine outpatient clinic. PARTICIPANTS: Ninety-seven participants, 21 to 65 years of age, with chronic, nonspecific NP. INTERVENTIONS: Participants were randomized to two trial arms: immediate OMT intervention or waiting period first. The intervention consisted of three to four OMT sessions over 4 to 6 weeks, after which the participants switched groups. MAIN OUTCOME MEASURES: Primary outcome measures were pain intensity (average and current) on the numerical rating scale and Neck Disability Index. Secondary outcomes included Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) health domains and Fear Avoidance Beliefs Questionnaire. Outcomes obtained prior to the cross-over allocation were evaluated using general linear models and after adjusting for baseline values. RESULTS: A total of 38 and 37 participants were available for the analysis in the OMT and waiting period groups, respectively. The results showed significantly better primary outcomes in the immediate OMT group for reductions in average pain (-1.02, 95% confidence interval [CI] -1.72, -0.32; p = .005), current pain (-1.02, 95% CI -1.75, -0.30; p = .006), disability (-5.30%, 95% CI -9.2%, -1.3%; p = .010) and improved secondary outcomes (PROMIS) related to sleep (-3.25, 95% CI -6.95, -1.54; p = .003), fatigue (-3.26, 95% CI -6.04, -0.48; p = .022), and depression (-2.59, 95% CI -4.73, -0.45; p = .018). The effect sizes were in the clinically meaningful range between 0.5 and 1 standard deviation. No study-related serious adverse events were reported. CONCLUSIONS: OMT is relatively safe and effective in reducing pain and disability along with improving sleep, fatigue, and depression in patients with chronic NP immediately following treatment delivered over approximately 4 to 6 weeks.

Model Simulations Challenge Reductionist Research Approaches to Studying Chronic Low Back Pain.

BACKGROUND: Traditionally, low back pain (LBP) is studied using a reductionist approach, in which the factors contributing to the clinical presentation of LBP are studied in isolation to identify the primary pathology or condition linked to LBP. We argue that reductionism may not be suitable for studying LBP, considering the complex, multifactorial nature of this condition. OBJECTIVES: To quantify the likelihood of successfully subclassifying patients with LBP and effectively targeting treatment based on a single dominant factor contributing to LBP. METHODS: Both analytical and numerical simulations (Monte Carlo) of 1 million patients with LBP were performed. Several factors contributing to LBP were randomly assigned to each individual. The following outcome measures were computed, as a function of the number of factors: the percentage of individuals who could be subclassified by identifying a single factor exceeding a certain threshold, and the average reduction in LBP when treatment eliminates the largest contributing factor versus a multimodal treatment that eliminates a number of the randomly selected factors. RESULTS: With an increasing number of factors, the probability of subclassifying an individual to a subgroup based on a single factor tends toward zero. A multimodal treatment arbitrarily addressing any 2 or more factors was more effective than diagnosing and treating a single factor that maximally contributed to LBP. CONCLUSION: Results suggest that reductionism is not appropriate for subclassifying patients with LBP or for targeting treatment. The use of reductionist approaches may explain some of the challenges when creating LBP classification systems and designing effective treatment interventions. J Orthop Sports Phys Ther 2019;49(6):477-481. Epub 15 May 2019. doi:10.2519/jospt.2019.8791.

Degenerative Spondylolisthesis Is Related to Multiparity and Hysterectomies in Older Women.

STUDY DESIGN: A case-control study. OBJECTIVE: To determine whether parity and abdominal surgeries are associated with degenerative spondylolisthesis (DS). SUMMARY OF BACKGROUND DATA: DS is considered to be a major cause of low back pain (LBP) in the older population, with greater prevalence of DS among women. Because LBP and impaired abdominal muscle function are common during pregnancy and post-partum, parity-related abdominal muscle deficiency, resulting in poor spinal mechanics, could be a factor in the development of DS in women. Indeed a relationship between the number of pregnancies and DS was reported in one study. METHODS: A total of 322 women between the ages of 40 and 80 (149 with DS and 173 controls) filled out a questionnaire providing information about their demographics, the number of full-term pregnancies, the number and types of abdominal surgeries (including cesarean section and hysterectomies), and age at menopause among other items. A binary logistic regression was used as a multivariate model to identify the variables associated with DS. RESULTS: Along with age and body mass index as covariates, the number of full-term pregnancies and the hysterectomy were significant predictors of DS. Other abdominal surgeries, cesarean section, or the number of years postmenopause were not significant predictors of DS in this regression model after adjusting for all other significant variables. CONCLUSION: Each full-term pregnancy seems to be associated with the 22% increase in odds of developing DS. Hysterectomy nearly doubles the odds of DS as compared to women who did not have hysterectomy. LEVEL OF EVIDENCE: 4.

Less precise motor control leads to increased agonist-antagonist muscle activation during stick balancing.

Human motor control has constraints in terms of its responsiveness, which limit its ability to successfully perform tasks. In a previous study, it was shown that the ability to balance an upright stick became progressively more challenging as the natural frequency (angular velocity without control) of the stick increased. Furthermore, forearm and trunk agonist and antagonist muscle activation increased as the natural frequency of the stick increased, providing evidence that the central nervous system produces agonist-antagonist muscle activation to match task dynamics. In the present study, visual feedback of the stick position was influenced by changing where subject focused on the stick during stick balancing. It was hypothesized that a lower focal height would degrade motor control (more uncertainty in tracking stick position), thus making balancing more challenging. The probability of successfully balancing the stick at four different focal heights was determined along with the average angular velocity of the stick. Electromyographic signals from forearm and trunk muscles were also recorded. As expected, the probability of successfully balancing the stick decreased and the average angular velocity of the stick increased as subjects focused lower on the stick. In addition, changes in the level of agonist and antagonist muscle activation in the forearm and trunk was linearly related to changes in the angular velocity of the stick during balancing. One possible explanation for this is that the central nervous system increases muscle activation to account for less precise motor control, possibly to improve the responsiveness of human motor control.

Sagittal rotational stiffness and damping increase in a porcine lumbar spine with increased or prolonged loading.

While the impact of load magnitude on spine dynamic parameters (stiffness and damping) has been reported, it is unclear how load history (exposure to prolonged loading) affects spine dynamic parameters in sagittal rotation. Furthermore, it is unknown if both spine stiffness and damping are equally affected to prolonged loading. Using a pendulum testing apparatus, the effect of load magnitude and load history on spine sagittal rotational stiffness and damping was assessed. Nine porcine lumbar functional spine units (FSUs) were tested in an increasing compressive load phase (ICP: 44.85, 68.55, 91.75, 114.6kg) and then a decreasing compressive load phase (DCP: 91.75, 68.55, and 44.85kg). Each trial consisted of flexing the FSU 5° and allowing it to oscillate unconstrained. During the ICP, both stiffness and damping linearly increased with load. However, in the DCP, stiffness and damping values were significantly higher than the identical load collected during the ICP, suggesting load history affects sagittal rotational dynamic parameters. In addition, spine damping was more affected by load history than spine stiffness. These results highlight the importance of controlling load magnitude and history when assessing spine dynamic parameters.

Prognosis based on creatine kinase isoenzyme MB, cardiac troponin I, and right ventricular size in stable patients with acute pulmonary embolism.

Prognosis of stable patients with acute pulmonary embolism (PE) has been assessed with cardiac troponin I (cTnI) and right ventricular (RV) function or size. Whether creatine kinase-MB isoenzyme (CK-MB) would add to the prognostic assessment is uncertain. We retrospectively assessed in-hospital mortality from PE in 392 stable patients to test the hypothesis that CK-MB would be of greater prognostic value than cTnI or RV size and we assessed whether combinations would increase prognostic value. CK-MB was high in 29 patients (7.4%); cTnI was high in 76 patients (19%) and intermediate in 78 patients (20%). The right ventricle was dilated in 128 patients (33%). Trends showed highest in-hospital mortality from PE in 4 of 29 (14%) with high CK-MB compared to 6 of 76 (7.9%) with high cTnI and 8 of 128 (6.3%) with RV dilatation (differences NS). High CK-MB and high cTnI provided added prognostic information only in patients with RV dilatation. Mortality with high CK-MB plus RV dilatation (4 of 19, 21%) tended to exceed mortality with high cTnI plus RV dilatation (5 of 39, 13%, NS). When CK-MB and cTnI were high and the right ventricle was dilated, PE mortality tended to be highest (4 of 14, 29%, NS). In conclusion, cardiac biomarkers contributed to prognosis only in patients with RV dilatation. CK-MB was the strongest predictor of death from PE but its prevalence was low, thus limiting its value as a single prognostic indicator. The combination of high CK-MB, high cTnI, and RV dilatation tended to indicate the highest mortality.

Nurse consultation support to primary care practices to increase delivery of health behavior services.

Tobacco use, lack of physical activity, poor diet, and alcohol use are the key preventable causes of death in the United States. This study tested the use of nurses as consultants to primary care practices to assist practice clinicians and staff in identifying and carrying out plans to help their adult patients improve these health behaviors. A pre-post chart audit was conducted, and 17 of 20 practices (85%, p = <.01) increased documentation of health behavior delivery a mean absolute increase of 5.5% after the intervention. Nurse consultation may be an effective strategy to increase health behavior delivery to patients in primary care.

Practice-based referrals to a tobacco cessation quit line: assessing the impact of comparative feedback vs general reminders.

PURPOSE: We undertook a study to assess the impact of comparative feedback vs general reminders on practice-based referrals to a tobacco cessation quit line and estimated costs for projected quit responses. METHODS: We conducted a group-randomized clinical trial comparing the impact of 6 quarterly (18 months) feedback reports (intervention) with that of general reminders (control) on practice-based clinician referrals to a quit-line service. Feedback reports were based on an Achievable Benchmark of Care approach using baseline practice, clinician, and patient survey responses, and referrals per quarter. Comparable quit responses and costs were estimated. RESULTS: Three hundred eight clinicians participated (171 family medicine, 88 internal medicine, 49 obstetrics-gynecology) from 87 primary care practices in Michigan. After 18 months, there were more referrals from the intervention than from the control practices (484 vs 220; P <.001). Practice facsimile (fax) referrals (84%, n = 595) exceeded telephone referrals (16%, n = 109), but telephone referrals resulted in greater likelihood of enrollment (77% telephone vs 44% fax, P <.001). The estimated number of smokers who quit based on the level of services utilized by referred smokers was 66 in the feedback and 36 in the gentle reminder practices. CONCLUSION: Providing comparative feedback on clinician referrals to a quit-line service had a modest impact with limited increased costs.

Is liquid-based pap testing affected by water-based lubricant?

OBJECTIVE: To estimate the effect of water-based lubricant on the liquid-based Pap test. METHODS: Two hundred women each had 2 simultaneous Pap test collections. One specimen was randomly contaminated with 0.5 mL of water-based lubricant after collection. The physician was blinded as to which collection was contaminated. Both specimens were sent for cytology. Cytopathologists were blinded to the study. The rate of abnormal cytology and discordance between the control and the contaminated specimens was estimated. The discordance of secondary diagnoses, such as yeast infections and bacterial vaginosis, was also estimated. RESULTS: The incidence of abnormal cytology was similar in the contaminated specimens and the control specimens (6.5%, 95% confidence interval [CI] 3.5-10.9% versus 7.0%, 95% CI 3.9-11.5%). The rate of disagreement between the 2 specimens collected from each patient was 7.5% (95% CI 4.6-12.1%) and is similar to previously published estimates of discordance using conventional cytology. Secondary diagnoses, such as yeast infections or bacterial vaginosis, were similar in both groups, suggesting no interference from the lubricant. CONCLUSION: Water-based lubricant does not affect liquid-based cervical cytology Pap testing. Water-based lubricant does not affect secondary diagnoses such as bacterial vaginosis or yeast infections. LEVEL OF EVIDENCE: II-1.