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.

Differences in human cervical spine kinematics for active and passive motions of symptomatic and asymptomatic subject groups.

Most musculoskeletal disorders of the head and neck regions cannot be identified through imaging techniques; therefore clinician-conducted assessments (passive motions) are used to evaluate the functional ability of these regions. Although active motions do not require interaction with a clinician, these movements can also provide diagnostic indicators of dysfunction. The purpose of this research was to determine whether kinematic measures differed between active and passive movements of participants in symptomatic and asymptomatic groups. Data obtained on cervical lateral flexion range of motion (ROM), coupled axial rotation, and the angular velocity of lateral flexion were statistically analyzed and demonstrated differences between active and passive motions for symptomatic and asymptomatic subjects. Active motions had higher angular velocities (P < .001) and larger ROMs, with greater lateral flexions (P < .05). The asymptomatic group produced a larger average lateral flexion of 7.9° at an average angular velocity of 2 deg/s greater than the symptomatic group. Trends with regard to group assignment were the same for active and passive motions. This work demonstrates the potential for using kinematic measures of active and passive motions to develop an objective standard for diagnoses of cervical dysfunction and supports validity of the clinician-based analysis to distinguish between participant groups.