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.

Stability threshold during seated balancing is sensitive to low back pain and safe to assess.

Challenging trunk neuromuscular control maximally using a seated balancing task is useful for unmasking impairments that may go unnoticed with traditional postural sway measures and appears to be safe to assess in healthy individuals. This study investigates whether the stability threshold, reflecting the upper limits in trunk neuromuscular control, is sensitive to pain and disability and is safe to assess in low back pain (LBP) patients. Seventy-nine subjects with non-specific LBP balanced on a robotic seat while rotational stiffness was gradually reduced. The critical rotational stiffness, KCrit, that marked the transition between stable and unstable balance was used to quantify the individual's stability threshold. The effects of current pain, 7-day average pain, and disability on KCrit were assessed, while controlling for age, sex, height, and weight. Adverse events (AEs) recorded at the end of the testing session were used to assess safety. Current pain and 7-day average pain were strongly associated with KCrit (current pain p < 0.001, 7-day pain p = 0.023), reflecting that people experiencing more pain have poorer trunk neuromuscular control. There was no evidence that disability was associated with KCrit, although the limited range in disability scores in subjects may have impacted the analysis. AEs were reported in 13 out of 79 total sessions (AE Severity: 12 mild, 1 moderate; AE Relatedness: 1 possibly, 11 probably, 1 definitely-related to the study). Stability threshold is sensitive to pain and appears safe to assess in people with LBP, suggesting it could be useful for identifying trunk neuromuscular impairments and guiding rehabilitation.

Quantifying trunk neuromuscular control using seated balancing and stability threshold.

Performance during seated balancing is often used to assess trunk neuromuscular control, including evaluating impairments in back pain populations. Balancing in less challenging environments allows for flexibility in control, which may not depend on health status but instead may reflect personal preferences. To make assessment less ambiguous, trunk neuromuscular control should be maximally challenged. Thirty-four healthy subjects balanced on a robotic seat capable of adjusting rotational stiffness. Subjects balanced while rotational stiffness was gradually reduced. The rotational stiffness at which subjects could no longer maintain balance, defined as critical stiffness (kCrit), was used to quantify the subjects' trunk neuromuscular control. A higher kCrit reflects poorer control, as subjects require a more stable base to balance. Subjects were tested on three days separated by 24 hours to assess test-retest reliability. Anthropometric (height and weight) and demographic (age and sex) influences on kCrit and its reliability were assessed. Height and age did not affect kCrit; whereas, being heavier (p < 0.001) and female (p = 0.042) significantly increased kCrit. Reliability was also affected by anthropometric and demographic factors, highlighting the potential problem of inflated reliability estimates from non-control related attributes. kCrit measurements appear reliable even after removing anthropometric and demographic influences, with adjusted correlations of 0.612 (95%CI: 0.433-0.766) versus unadjusted correlations of 0.880 (95%CI: 0.797-0.932). Besides assessment, trainers and therapists prescribing exercise could use the seated balance task and kCrit to precisely set difficulty level to a percentage of the subject's stability threshold to optimize improvements in trunk neuromuscular control and spine health.

Feasibility of Incorporating Test-Retest Reliability and Model Diversity in Identification of Key Neuromuscular Pathways During Head Position Tracking.

To study the complex neuromuscular control pathways in human movement, biomechanical parametric models and system identification methods are employed. Although test-retest reliability is widely used to validate the outcomes of motor control tasks, it was not incorporated in system identification methods. This study investigates the feasibility of incorporating test-retest reliability in our previously published method of selecting sensitive parameters. We consider the selected parameters via this novel approach to be the key neuromuscular parameters, because they meet three criteria: reduced variability, improved goodness of fit, and excellent reliability. These criteria ensure that the parameter variability is below a user-defined value, the number of these parameters is maximized to enhance goodness of fit, and their test-retest reliability is above a user-defined value. We measured variability, the goodness of fit, and reliability using Fisher information matrix, variance accounted for, and intraclass correlation, respectively. We also incorporated model diversity as a fourth optional criterion to narrow down the solution space of key parameters. We applied this approach to the head position tracking tasks in axial rotation and flexion/extension. A total of forty healthy subjects performed the tasks during two visits. With variability and reliability measures ≤0.35 and ≥0.75, respectively, we selected three key parameters out of twelve with the goodness of fit >69%. The key parameters were associated with at least two neuromuscular pathways out of four modeled pathways (visual, proprioceptive, vestibular, and intrinsic), which is a measure of model diversity. Therefore, it is feasible to incorporate reliability and diversity in system identification of key neuromuscular pathways in our application.

Inferring Control Intent during Seated Balance using Inverse Model Predictive Control.

Patients with Low Back Pain (LBP) are suggested to follow a protective coping strategy. Therefore, rehabilitation of these patients requires estimating their motor control strategies (the control intent). In this letter, we present an approach that infers the control intent by solving an inverse Model Predictive Control (iMPC) problem. The standard Model Predictive Control (MPC) structure includes constraints, therefore, it allows us to model the physiological constraints of motor control. We devised an iMPC algorithm to solve iMPC problems with experimentally collected output trajectories. We used experimental data of one healthy subject during a seated balance test that used a physical Human-Robot Interaction (pHRI). Results show that the estimated MPC weights reflected the task instructions given to the subject and yielded an acceptable goodness of fit. The iMPC solution suggests that the subject's control intent was dominated by minimizing the squared sum of a combination of the upper-body and lower-body angles and velocities.

Selecting Sensitive Parameter Subsets in Dynamical Models With Application to Biomechanical System Identification.

Estimating many parameters of biomechanical systems with limited data may achieve good fit but may also increase 95% confidence intervals in parameter estimates. This results in poor identifiability in the estimation problem. Therefore, we propose a novel method to select sensitive biomechanical model parameters that should be estimated, while fixing the remaining parameters to values obtained from preliminary estimation. Our method relies on identifying the parameters to which the measurement output is most sensitive. The proposed method is based on the Fisher information matrix (FIM). It was compared against the nonlinear least absolute shrinkage and selection operator (LASSO) method to guide modelers on the pros and cons of our FIM method. We present an application identifying a biomechanical parametric model of a head position-tracking task for ten human subjects. Using measured data, our method (1) reduced model complexity by only requiring five out of twelve parameters to be estimated, (2) significantly reduced parameter 95% confidence intervals by up to 89% of the original confidence interval, (3) maintained goodness of fit measured by variance accounted for (VAF) at 82%, (4) reduced computation time, where our FIM method was 164 times faster than the LASSO method, and (5) selected similar sensitive parameters to the LASSO method, where three out of five selected sensitive parameters were shared by FIM and LASSO methods.

Reliability of assessing postural control during seated balancing using a physical human-robot interaction.

This study evaluated the within- and between-visit reliability of a seated balance test for quantifying trunk motor control using input-output data. Thirty healthy subjects performed a seated balance test under three conditions: eyes open (EO), eyes closed (EC), and eyes closed with vibration to the lumbar muscles (VIB). Each subject performed three trials of each condition on three different visits. The seated balance test utilized a torque-controlled robotic seat, which together with a sitting subject resulted in a physical human-robot interaction (pHRI) (two degrees-of-freedom with upper and lower body rotations). Subjects balanced the pHRI by controlling trunk rotation in response to pseudorandom torque perturbations applied to the seat in the coronal plane. Performance error was expressed as the root mean square (RMSE) of deviations from the upright position in the time domain and as the mean bandpass signal energy (Emb) in the frequency domain. Intra-class correlation coefficients (ICC) quantified the between-visit reliability of both RMSE and Emb. The empirical transfer function estimates (ETFE) from the perturbation input to each of the two rotational outputs were calculated. Coefficients of multiple correlation (CMC) quantified the within- and between-visit reliability of the averaged ETFE. ICCs of RMSE and Emb for all conditions were ≥0.84. The mean within- and between-visit CMCs were all ≥0.96 for the lower body rotation and ≥0.89 for the upper body rotation. Therefore, our seated balance test consisting of pHRI to assess coronal plane trunk motor control is reliable.

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.

Quantitative measures of sagittal plane head-neck control: a test-retest reliability study.

Determining the reliability of measurements used to quantify head-neck motor control is necessary before they can be used to study the effects of injury or treatment interventions. Thus, the purpose of this study was to determine the within- and between-day reliability of position tracking, position stabilization and force tracking tasks to quantify head-neck motor control. Ten asymptomatic subjects performed these tasks on two separate days. Position and force tracking tasks required subjects to track a pseudorandom square wave input signal by controlling their head-neck angular position (position tracking) or the magnitude of isometric force generated against a force sensor by the neck musculature (force tracking) in the sagittal plane. Position stabilization required subjects to maintain an upright head position while pseudorandom perturbations were applied to the upper body using a robotic platform. Within-day and between-day reliability of the frequency response curves were assessed using coefficients of multiple correlations (CMC). Root mean square error (RMSE) and mean bandpass signal energy, were computed for each task and between-day reliability was calculated using intra-class correlation coefficients (ICC). Within- and between-day CMCs for the position and force tracking tasks were all ≥0.96, while CMCs for position stabilization ranged from 0.72 to 0.82. ICCs for the position and force tracking tasks were all ≥0.93. For position stabilization, ICCs for RMSE and mean bandpass signal energy were 0.66 and 0.72, respectively. Measures of sagittal plane head-neck motor control using position tracking, position stabilization and force tracking tasks were demonstrated to be reliable.

Reliability of assessing trunk motor control using position and force tracking and stabilization tasks.

System-based methods have been applied to assess trunk motor control in people with and without back pain, although the reliability of these methods has yet to be established. Therefore, the goal of this study was to quantify within- and between-day reliability using systems-based methods involving position and force tracking and stabilization tasks. Ten healthy subjects performed six tasks, involving tracking and stabilizing of trunk angular position in the sagittal plane, and trunk flexion and extension force. Tracking tasks involved following a one-dimensional, time-varying input signal displayed on a screen by changing trunk position (position tracking) or trunk force (force tracking). Stabilization tasks involved maintaining a constant trunk position (position stabilization) or constant trunk force (force stabilization) while a sagittal plane disturbance input was applied to the pelvis using a robotic platform. Time and frequency domain assessments of error (root mean square and H2 norm, respectively) were computed for each task on two separate days. Intra-class correlation coefficients (ICC) for error and coefficients of multiple correlations (CMC) for frequency response curves were used to quantify reliability of each task. Reliability for all tasks was excellent (between-day ICC≥0.8 and CMC>0.75, within-day CMC>0.85). Therefore, position and force control tasks used to assess trunk motor control can be deemed reliable.