Subhash Aryal

Recovery From Chronic Low Back Pain After Osteopathic Manipulative Treatment: A Randomized Controlled Trial

CONTEXT Little is known about recovery after spinal manipulation in patients with low back pain (LBP). OBJECTIVE To assess recovery from chronic LBP after a short regimen of osteopathic manipulative treatment (OMT) in a responder analysis of the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial. METHODS A randomized double-blind, sham-controlled trial was conducted to determine the efficacy of 6 OMT sessions over 8 weeks. Recovery was assessed at week 12 using a composite measure of pain recovery (10 mm or less on a 100-mm visual analog scale) and functional recovery (2 or less on the Roland-Morris Disability Questionnaire for back-specific functioning). The RRs and numbers-needed-to-treat (NNTs) for recovery with OMT were measured, and corresponding cumulative distribution functions were plotted according to baseline LBP intensity and back-specific functioning. Multiple logistic regression was used to compute the OR for recovery with OMT while simultaneously controlling for potential confounders. Sensitivity analyses were performed to corroborate the primary results. RESULTS There were 345 patients who met neither of the recovery criteria at baseline in the primary analyses and 433 patients who met neither or only 1 of these criteria in the sensitivity analyses. There was a large treatment effect for recovery with OMT (RR, 2.36; 95% CI, 1.31-4.24; P=.003), which was associated with a clinically relevant NNT (8.9; 95% CI, 5.4-25.5). This significant finding persisted after adjustment for potential confounders (OR, 2.92; 95% CI, 1.43-5.97; P=.003). There was also a significant interaction effect between OMT and comorbid depression (P=.02), indicating that patients without depression were more likely to recover from chronic LBP with OMT (RR, 3.21; 95% CI, 1.59-6.50; P<.001) (NNT, 6.5; 95% CI, 4.2-14.5). The cumulative distribution functions demonstrated optimal RR and NNT responses in patients with moderate to severe levels of LBP intensity and back-specific dysfunction at baseline. Similar results were observed in the sensitivity analyses. CONCLUSIONS The OMT regimen was associated with significant and clinically relevant measures for recovery from chronic LBP. A trial of OMT may be useful before progressing to other more costly or invasive interventions in the medical management of patients with chronic LBP. (ClinicalTrials.gov number NCT00315120).

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.

Somatic dysfunction and use of osteopathic manual treatment techniques during ambulatory medical care visits: a CONCORD-PBRN study.

CONTEXT Osteopathic manual treatment (OMT) of somatic dysfunction is a unique approach to medical care that may be studied within a practice-based research network. OBJECTIVE To measure patient characteristics and osteopathic physician practice patterns within the Consortium for Collaborative Osteopathic Research Development-Practice-Based Research Network (CONCORD-PBRN). DESIGN Cross-sectional card study. SETTING Eleven member clinics within the CONCORD-PBRN coordinated by The Osteopathic Research Center. PATIENTS A total of 668 patients seen between January and March 2013. MAIN STUDY MEASURES Patient age and sex; primary diagnoses; somatic dysfunction as manifested by tenderness, asymmetry, restricted motion, or tissue texture changes; and use of 14 OMT techniques. Results were stratified by anatomical region and adjusted for clustering within member clinics. Clustering was measured by the intracluster correlation coefficient. RESULTS Patient ages ranged from 7 days to 87 years (adjusted mean age, 49.2 years; 95% confidence interval [CI], 43.3-55.1 years). There were 450 females (67.4%) and 508 patient visits (76.0%) involved a primary diagnosis of disease of the musculoskeletal system and connective tissue. Structural examination was performed during 657 patient visits (98.4%), and 649 visits (97.2%) involved OMT. Restricted motion and tenderness were the most and least common palpatory findings, respectively. Cranial (1070 [14.5%]), myofascial release (1009 [13.7%]), muscle energy (1001 [13.6%]), and counterstrain (980 [13.3%]) techniques were most commonly used, accounting for more than one-half of the OMT provided. Pediatric patients were more likely than adults to receive OMT within the head (adjusted odds ratio [OR], 9.53; 95% CI, 1.28-71.14). Geriatric patients were more likely than adults to receive a structural examination (adjusted OR, 1.83; 95% CI, 1.09-3.07) and OMT (adjusted OR, 1.62; 1.02-2.59) within the lower extremity. Females were more likely than males to receive a structural examination (adjusted OR, 2.44; 95% CI, 1.44-4.16) and OMT (adjusted OR, 2.11; 95% CI, 1.26-3.52) within the sacrum and OMT within the pelvis (adjusted OR, 1.79; 95% CI, 1.12-2.88). Intracluster correlation coefficients for the 4 most commonly used OMT techniques ranged from 0.34 to 0.72. CONCLUSION This study provides proof of concept of the feasibility of studying osteopathic medical practice on a national level by developing and growing the CONCORD-PBRN.

Sample Size Determination for Studies with Repeated Continuous Outcomes.

FULL DISCLOSURE POLICY In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support, all CME providers are required to disclose to the activity audience the relevant financial relationships of the planners, teachers, and authors involved in the development of CME content. An individual has a relevant financial relationship if he or she has a financial relationship in any amount occurring in the last 12 months with a commercial interest whose products or services are discussed in the CME activity content over which the individual has control. Relationship information appears at the beginning of each CME-accredited article in this issue.

Targeting Patient Subgroups With Chronic Low Back Pain for Osteopathic Manipulative Treatment: Responder Analyses From a Randomized Controlled Trial

CONTEXT Osteopathic manipulative treatment (OMT) is often used to treat patients with low back pain (LBP). OBJECTIVE To identify subgroups of patients with chronic LBP who achieve medium to large treatment effects with OMT based on responder analyses involving pain and functioning outcomes from the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial. METHODS This randomized, double-blind, sham-controlled trial involving 455 patients in Dallas-Fort Worth was conducted from 2006 to 2011. A 100-mm visual analog scale (VAS) for LBP intensity and the Roland-Morris Disability Questionnaire (RMDQ) for back-specific functioning were used to assess primary and secondary outcomes, respectively. Substantial improvement was defined as 50% or greater reduction at week 12 compared with baseline. Cumulative distribution functions for the RR and number-needed-to-treat (NNT) were used to assess response. RESULTS Medium treatment effects for LBP intensity were observed overall (RR, 1.41; 95% CI, 1.13-1.76; P=.002; NNT, 6.9; 95% CI, 4.3-18.6). However, large treatment effects were observed in patients with baseline VAS scores of 35 mm or greater. Although OMT was not associated with overall substantial improvement in back-specific functioning, patients with baseline RMDQ scores of 7 or greater experienced medium effects, and patients with baseline scores 16 or greater experienced large effects that were significant. The OMT effects for LBP intensity and back-specific functioning were independent of baseline patient demographic characteristics, comorbid medical conditions, and medication use for LBP during the trial. CONCLUSIONS Subgrouping according to baseline levels of chronic LBP intensity and back-specific functioning appears to be a simple strategy for identifying sizeable numbers of patients who achieve substantial improvement with OMT and may thereby be less likely to use more costly and invasive interventions. (ClinicalTrials.gov number NCT00315120).

Aerosol optical depth as a measure of particulate exposure using imputed censored data, and relationship with childhood asthma hospital admissions for 2004 in athens, Greece.

An understanding of human health implications from atmosphere exposure is a priority in both the geographic and the public health domains. The unique properties of geographic tools for remote sensing of the atmosphere offer a distinct ability to characterize and model aerosols in the urban atmosphere for evaluation of impacts on health. Asthma, as a manifestation of upper respiratory disease prevalence, is a good example of the potential interface of geographic and public health interests. The current study focused on Athens, Greece during the year of 2004 and (1) demonstrates a systemized process for aligning data obtained from satellite aerosol optical depth (AOD) with geographic location and time, (2) evaluates the ability to apply imputation methods to censored data, and (3) explores whether AOD data can be used satisfactorily to investigate the association between AOD and health impacts using an example of hospital admission for childhood asthma. This work demonstrates the ability to apply remote sensing data in the evaluation of health outcomes, that the alignment process for remote sensing data is readily feasible, and that missing data can be imputed with a sufficient degree of reliability to develop complete datasets. Individual variables demonstrated small but significant effect levels on hospital admission of children for AOD, nitrogen oxides (NOx), relative humidity (rH), temperature, smoke, and inversely for ozone. However, when applying a multivari-able model, an association with asthma hospital admissions and air quality could not be demonstrated. This work is promising and will be expanded to include additional years.

Manual therapy, exercise, and education for low back pain and pelvic pain during pregnancy

TO THE EDITORS: We read with interest the paper by George et al on a multimodal intervention involving manual therapy, exercise, and education for low back pain and pelvic pain during pregnancy. Although the authors concluded that musculoskeletal and obstetric management (MOM) in midpregnancy is more beneficial to patients than standard obstetric care, they acknowledged several important study limitations including the absence of active or placebo comparators, the inability to independently assess individual components of the multimodal intervention, and likely the enrollment of patients motivated to achieve successful results, thereby having an impact on the generalizability of results. However, other aspects of study design, analysis, and reporting raise further questions. The eligibility criteria specified women with fetuses of 24-28 weeks’ gestation; however, data on gestational age at baseline (cited in Table 1) suggest that more than half of the patients were prematurely enrolled. Furthermore, in the absence of recorded logs, patients in the MOM group may have received up to 10 or more weekly treatments by 33 weeks’ gestation as opposed to only 4-6 treatments as reported. The reported power analysis allowed for 20% attrition, suggesting that an intention-to-treat analysis was not used. The Consolidated Standards of Reporting Trials diagram reported that 19% overall and 24% in the MOM group were lost to follow-up. The impact of these relatively high levels of attrition on study outcomes was not assessed and reported. Furthermore, the power analysis was reportedly based on a numerical rating scale (NRS) and the Quebec Task Force Disability Questionnaire (QDQ) as the primary outcomes. Yet it appears that the sample size to achieve statistical power of 0.9 was initially computed for the QDQ (n 1⁄4 120) and that the statistical power achievable with 120 patients on the NRS was secondarily computed and reported (power, 0.96). Correspondingly, the ClinicalTrials.gov registry lists the QDQ as the only primary outcome, with the NRS and other variables as secondary outcomes. It is commendable that the authors used a Bonferroni correction to reduce the likelihood of type 1 errors in testing multiple hypotheses; however, the rationale for using 10 in the denominator to compute the appropriately adjusted P value is unclear. It is also puzzling that P values for interaction were reported for both the MOM and standard obstetric care groups (cited in Tables 2 and 3; presumably, 3 P values for interaction in Table 3 were misplaced). Overall, these methodological issues and reporting inconsistencies diminish the potential impact of this important study and call into question the significance of several reported findings. -

Anterior chamber perfusion versus posterior chamber perfusion does not influence measurement of aqueous outflow facility in living mice by constant flow infusion

ABSTRACT Mice are now routinely utilized in studies of aqueous humor outflow dynamics. In particular, conventional aqueous outflow facility (C) is routinely measured via perfusion of the aqueous chamber by a number of laboratories. However, in mouse eyes perfused ex‐vivo, values for C are variable depending upon whether the perfusate is introduced into the posterior chamber (PC) versus the anterior chamber (AC). Perfusion via the AC leads to posterior bowing of the iris, and traction on the iris root/scleral spur, which may increase C. Perfusion via the PC does not yield this effect. But the equivalent situation in living mice has not been investigated. We sought to determine whether AC versus PC perfusion of the living mouse eye may lead to different values for C. All experiments were conducted in C57BL/6J mice (all ♀) between the ages of 20 and 30 weeks. Mice were divided into groups of 3–4 animals each. In all groups, both eyes were perfused. C was measured in groups 1 and 2 by constant flow infusion (from a 50 &mgr;L microsyringe) via needle placement in the AC, and in the PC, respectively. To investigate the effect of ciliary muscle (CM) tone on C, groups 3 and 4 were perfused live via the AC or PC with tropicamide (muscarinic receptor antagonist) added to the perfusate at a concentration of 100 &mgr;M. To investigate immediate effect of euthanasia, groups 5 and 6 were perfused 15–30 min after death via the AC or PC. To investigate the effect of CM tone on C immediately following euthanasia, groups 7 and 8 were perfused 15–30 min after death via the AC or PC with tropicamide added to the perfusate at a concentration of 100 &mgr;M. C in Groups 1 (AC perfusion) and 2 (PC perfusion) was computed to be 19.5 ± 0.8 versus 21.0 ± 2.1 nL/min/mmHg, respectively (mean ± SEM, p > 0.4, not significantly different). In live animals in which tropicamide was present in the perfusate, C in Group 3 (AC perfusion) was significantly greater than C in Group 4 (PC perfusion) (22.0 ± 4.0 versus 14.0 ± 2.0 nL/min/mmHg, respectively, p = 0.0021). In animals immediately following death, C in groups 5 (AC perfusion) and 6 (PC perfusion) was computed to be 21.2 ± 2.0 versus 22.8 ± 1.4 nL/min/mmHg, respectively (mean ± SEM, p = 0.1196, not significantly different). In dead animals in which tropicamide was present in the perfusate, C in group 7 (AC perfusion) was greater than C in group 8 (PC perfusion) (20.6 ± 1.4 versus 14.2 ± 2.6 nL/min/mmHg, respectively, p < 0.0001). C in eyes in situ in living mice or euthanized animals within 15–30 min post mortem is not significantly different when measured via AC perfusion or PC perfusion. In eyes of live or freshly euthanized mice, C is greater when measured via AC versus PC perfusion when tropicamide (a mydriatic and cycloplegic agent) is present in the perfusate. HighlightsIn the living mouse eye, C is pressure independent over range of IOP 15–35 mmHg.Anterior chamber (AC) versus posterior chamber (PC) perfusion does not influence C.In the presence of muscarinic blockade, C is less when measured via PC perfusion.This is also seen in mouse eyes perfused in situ immediately following euthanasia.

A pilot mobile integrated healthcare program for frequent utilizers of emergency department services

Purpose: To examine whether or not a mobile integrated health (MIH) program may improve health‐related quality of life while reducing emergency department (ED) transports, ED admissions, and inpatient hospital admissions in frequent utilizers of ED services. Methods: A small retrospective evaluation assessing pre‐ and post‐program quality of life, ED transports, ED admissions, and inpatient hospital admissions was conducted in patients who frequently used the ED for non‐emergent or emergent/primary care treatable conditions. Results: Pre‐ and post‐program data available on 64 program completers are reported. Of those with mobility problems (n = 42), 38% improved; those with problems performing usual activities (N = 45), 58% reported improvement; and of those experiencing moderate to extreme pain or discomfort (N = 48), 42% reported no pain or discomfort after program completion. Frequency of ED transports decreased (5.34 ± 6.0 vs. 2.08 ± 3.3; p < 0.000), as did ED admissions (9.66 ± 10.2 vs. 3.30 ± 4.6; p < 0.000), and inpatient hospital admissions (3.11 ± 5.5 vs. 1.38 ± 2.5; p = 0.003). Conclusion: Results suggest that MIH participation is associated with improved quality of life, reduced ED transports, ED admissions, and inpatient hospital admissions. The MIH program may have potential to improve health outcomes in patients who are frequent ED users for non‐emergent or emergent/primary care treatable conditions by teaching them how to proactively manage their health and adhere to therapeutic regimens. Programmatic reasons for these improvements may include psychosocial bonding with participants who received in‐home care, health coaching, and the MIH teams 24/7 availability that provided immediate healthcare access.

The Relationship Between Humeral Retrotorsion and Shoulder Range of Motion in Baseball Players With an Ulnar Collateral Ligament Tear

Background: Humeral retrotorsion has been investigated in relation to shoulder range of motion (ROM) in healthy baseball players. Currently, there is limited information on the osseous anatomy and development of ulnar collateral ligament (UCL) tears. Purpose: To determine the relationship between humeral retrotorsion and shoulder ROM in baseball players with a UCL tear. Study Design: Cross-sectional study; Level of evidence, 3. Methods: Fifty-four baseball players (mean age, 18.5 ± 2.0 years) with a UCL tear volunteered for this study. Participants were measured bilaterally for shoulder internal (IR) and external rotation (ER) ROM and humeral retrotorsion. Differences between sides (involved to uninvolved) were used to calculate the glenohumeral internal rotation deficit (GIRD), external rotation ROM difference (ERDiff), total rotational motion difference (TRM), and humeral retrotorsion difference (HTDiff). A multivariate regression analysis was performed with GIRD, ERDiff, and TRM regressing on HTDiff. Univariate analysis was performed to further evaluate the effect of the predictors on each outcome separately. To control for the effect of age, weight, duration of symptoms, and years of experience, the variables were included as covariates. An a priori level was set at P < .05. Results: There was a statistically significant relationship between the GIRD, ERDiff, and TRM results compared with HTDiff (P = .003). Independent analysis revealed a statistically significant relationship between GIRD and HTDiff (P = .004) and between ERDiff and HTDiff (P = .003) but no significant relationship between TRM and HTDiff (P = .999). After adjusting for age, weight, duration of symptoms, years of experience, dominant arm, and position, a significant relationship was found between GIRD and HTDiff (P = .05) and between ERDiff and HTDiff (P = .01). No significant relationship was found between TRM and HTDiff (P = .54). Adjusted univariate regression analysis determined that HTDiff explains approximately 16% of the variance in GIRD (r 2 = 0.158) and approximately 24% of the variance in ERDiff (r 2 = 0.237). Conclusion: In baseball players with a UCL tear, approximately 16% of the variance in GIRD and 24% of the variance in ERDiff can be attributed to differences found in humeral retrotorsion between sides. This indicates that humeral retroversion contributes significantly to GIRD and increased ER ROM in baseball players. Recognition of differences in humeral retrotorsion between the dominant and nondominant upper extremities may help explain some but not all of the changes in shoulder ROM commonly seen in baseball players.