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Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial.

ABSTRACT: BACKGROUND:Spinal manipulative therapy (SMT) includes biomechanical parameters that vary between clinicians, but for which the influence on the therapy clinical effects is unknown. This parallel-randomized controlled trial aimed to investigate the effect of SMT biomechanical parameters on the outcomes of participants with chronic thoracic pain (CTP) following three treatment sessions (follow-up at one week). METHODS:Adults reporting CTP (pain within the evaluated region [T6 to T8] for ?3?months) were asked to participate in a four-session trial. At the first session, participants were randomly assigned to one of three experimental groups (different SMT doses) or the control group (no SMT). During the first three sessions, one SMT was executed at T7 for the experimental groups, while a 5-min rest was provided to the control group. SMT were delivered through an apparatus using a servo-controlled linear actuator motor and doses consisted of peak forces, impulse durations, and rates of force application set at 135?N, 125?ms and 920?N/s (group 1), at 250?N, 125?ms and 1840?N/s (group 2), and at 250?N, 250?ms, 920?N/s (group 3). Disability and pain intensity were evaluated at each session (primary outcomes). Spinal stiffness was assessed before-and-after each SMT/rest and at follow-up. Tenderness and muscle activity were evaluated during each spinal stiffness trial. Improvement was evaluated at follow-up. Differences in outcomes between groups and sessions were evaluated as well as factors associated with clinical improvement. RESULTS:Eighty-one participants were recruited and 17, 20, 20 participants of the three experimental groups and 18 of the control group completed the protocol. In exception of higher pain intensity at baseline in the control group, no between-group differences were found for any of the outcomes. A decrease in pain intensity, disability, spinal stiffness, and tenderness during spinal stiffness were observed (p-values

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PROVIDER: S-EPMC6339327 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial.

Pagé Isabelle I Descarreaux Martin M

BMC musculoskeletal disorders 20190118 1

<h4>Background</h4>Spinal manipulative therapy (SMT) includes biomechanical parameters that vary between clinicians, but for which the influence on the therapy clinical effects is unknown. This parallel-randomized controlled trial aimed to investigate the effect of SMT biomechanical parameters on the outcomes of participants with chronic thoracic pain (CTP) following three treatment sessions (follow-up at one week).<h4>Methods</h4>Adults reporting CTP (pain within the evaluated region [T6 to T8] ...[more]

PMID: 30658622

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Project description:OBJECTIVE:The objective was to compare thoracic spinal stiffness between healthy participants and participants with chronic thoracic pain and to explore the associations between spinal stiffness, pain and muscle activity. The reliability of spinal stiffness was also evaluated. MATERIAL AND METHODS:Spinal stiffness was assessed from T5 to T8 using a mechanical device in 25 healthy participants and 50 participants with chronic thoracic pain (symptoms had to be reported within the evaluated region of the back). The spinal levels for which spinal stiffness was measured were standardized (i.e. T5 to T8 for all participants) to minimize between-individual variations due to the evaluation of different spinal levels. The device load and displacement data were used to calculate the global and terminal spinal stiffness coefficients at each spinal level. Immediately after each assessment, participants were asked to rate their pain intensity during the trial, while thoracic muscle activity was recorded during the load application using surface electromyography electrodes (sEMG). Within- and between-day reliability were evaluated using intraclass correlation coefficients (ICC), while the effects of chronic thoracic pain and spinal levels on spinal stiffness and sEMG activity were assessed using mixed model ANOVAs. Correlations between pain intensity, muscle activity and spinal stiffness were also computed. RESULTS:ICC values for within- and between-day reliability of spinal stiffness ranged from 0.67 to 0.91 and from 0.60 to 0.94 (except at T5), respectively. A significant decrease in the global (F1,73 = 4.04, p = 0.048) and terminal (F1,73 = 4.93, p = 0.03) spinal stiffness was observed in participants with thoracic pain. sEMG activity was not significantly different between groups and between spinal levels. Pain intensity was only significantly and "moderately" correlated to spinal stiffness coefficients at one spinal level (-0.29?r?-0.51), while sEMG activity and spinal stiffness were not significantly correlated. CONCLUSION:The results suggest that spinal stiffness can be reliably assessed using a mechanical device and that this parameter is decreased in participants with chronic thoracic pain. Studies are required to determine the value of instrumented spinal stiffness assessment in the evaluation and management of patients with chronic spine-related pain.

Project description:Background contextSpinal manipulation (SM) is a common treatment for neck and back pain, theorized to mechanically affect the spine leading to therapeutic mechanical changes. The link between specific mechanical effects and clinical improvement is not well supported. SM's therapeutic action may instead be partially mediated within the central nervous system.PurposeTo introduce brain-based models of pain for spinal pain and manual therapy research, characterize the distributed central mechanisms of SM, and advance the preliminary validation of brain-based models as potential clinical biomarkers of pain.Study designSecondary analysis of two functional magnetic resonance imaging studies investigating the effect of thoracic SM on pain-related brain activity: A non-controlled, non-blinded study in healthy volunteers (Study 1, n = 10, 5 females, and mean age = 31.2 ± 10.0 years) and a randomized controlled study in participants with acute to subacute neck pain (Study 2, n = 24, 16 females, mean age = 38.0 ± 15.1 years).MethodsFunctional magnetic resonance imaging was performed during noxious mechanical stimulation of the right index finger cuticle pre- and post-intervention. The effect of SM on pain-related activity was studied within brain regions defined by the Neurologic Pain Signature (NPS) that are predictive of physical pain.ResultsIn Study 1, evoked mechanical pain (p < 0.001) and NPS activation (p = 0.010) decreased following SM, and the changes in evoked pain and NPS activation were correlated (rRM2 = 0.418, p = 0.016). Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (rRM2 = 0.477, p = 0.019). In Study 2, neck pain (p = 0.046) and NPS (p = 0.033) activation decreased following verum but not sham SM. Associations between evoked pain, neck pain, and NPS activation, were not significant and less clear, possibly due to inadequate power, methodological limitations, or other confounding factors.ConclusionsThe findings provide preliminary evidence that SM may alter the processing of pain-related brain activity within specific pain-related brain regions and support the use of brain-based models as clinical biomarkers of pain.

Project description:Background:Low back pain (LBP) is a common disabling condition in older adults which often limits physical function and diminishes quality of life. Two clinical trials in older adults have shown spinal manipulative therapy (SMT) results in similar or small improvements relative to medical care; however, the effectiveness of adding SMT or rehabilitative exercise to home exercise is unclear. Methods:We conducted a randomized clinical trial assessing the comparative effectiveness of adding SMT or supervised rehabilitative exercise to home exercise in adults 65 or older with sub-acute or chronic LBP. Treatments were provided over 12-weeks and self-report outcomes were collected at 4, 12, 26, and 52 weeks. The primary outcome was pain severity. Secondary outcomes included back disability, health status, medication use, satisfaction with care, and global improvement. Linear mixed models were used to analyze outcomes. The primary analysis included longitudinal outcomes in the short (week 4-12) and long-term (week 4-52). An omnibus test assessing differences across all groups over the year was used to control for multiplicity. Secondary analyses included outcomes at each time point and responder analyses. This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration. Results:241 participants were randomized and 230 (95%) provided complete primary outcome data. The primary analysis showed group differences in pain over the one-year were small and not statistically significant. Pain severity was reduced by 30 to 40% after treatment in all 3 groups with the largest difference (eight percentage points) favoring SMT and home exercise over home exercise alone. Group differences at other time points ranged from 0 to 6 percentage points with no consistent pattern favoring one treatment. One-year post-treatment pain reductions diminished in all three groups. Secondary self-report outcomes followed a similar pattern with no important group differences, except satisfaction with care, where the two combination groups were consistently superior to home exercise alone. Conclusions:Adding spinal manipulation or supervised rehabilitative exercise to home exercise alone does not appear to improve pain or disability in the short- or long-term for older adults with chronic low back pain, but did enhance satisfaction with care. Trial registration:NCT00269321.

Project description:BACKGROUND CONTEXT:Chronic neck pain is a prevalent and disabling condition among older adults. Despite the large burden of neck pain, little is known regarding the cost-effectiveness of commonly used treatments. PURPOSE:This study aimed to estimate the cost-effectiveness of home exercise and advice (HEA), spinal manipulative therapy (SMT) plus HEA, and supervised rehabilitative exercise (SRE) plus HEA. STUDY DESIGN/SETTING:Cost-effectiveness analysis conducted alongside a randomized clinical trial (RCT) was performed. PATIENT SAMPLE:A total of 241 older adults (?65 years) with chronic mechanical neck pain comprised the patient sample. OUTCOME MEASURES:The outcome measures were direct and indirect costs, neck pain, neck disability, SF-6D-derived quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 1-year time horizon. METHODS:This work was supported by grants from the National Center for Complementary and Integrative Health (#F32AT007507), National Institute of Arthritis and Musculoskeletal and Skin Diseases (#P60AR062799), and Health Resources and Services Administration (#R18HP01425). The RCT is registered at ClinicalTrials.gov (#NCT00269308). A societal perspective was adopted for the primary analysis. A healthcare perspective was adopted as a sensitivity analysis. Cost-effectivenesswas a secondary aim of the RCT which was not powered for differences in costs or QALYs. Differences in costs and clinical outcomes were estimated using generalized estimating equations and linear mixed models, respectively. Cost-effectiveness acceptability curves were calculated to assess the uncertainty surrounding cost-effectiveness estimates. RESULTS:Total costs for SMT+HEA were 5% lower than HEA (mean difference: -$111; 95% confidence interval [CI] -$1,354 to $899) and 47% lower than SRE+HEA (mean difference: -$1,932; 95% CI -$2,796 to -$1,097). SMT+HEA also resulted in a greater reduction of neck pain over the year relative to HEA (0.57; 95% CI 0.23 to 0.92) and SRE+HEA (0.41; 95% CI 0.05 to 0.76). Differences in disability and QALYs favored SMT+HEA. The probability that adding SMT to HEA is cost-effective at willingness to pay thresholds of $50,000 to $200,000 per QALY gained ranges from 0.75 to 0.81. If adopting a health-care perspective, costs for SMT+HEA were 66% higher than HEA (mean difference: $515; 95% CI $225 to $1,094), resulting in an ICER of $55,975 per QALY gained. CONCLUSION:On average, SMT+HEA resulted in better clinical outcomes and lower total societal costs relative to SRE+HEA and HEA alone, with a 0.75 to 0.81 probability of cost-effectiveness for willingness to pay thresholds of $50,000 to $200,000 per QALY.

Project description:BackgroundRecent experimental research has suggested that spinal manipulative therapy (SMT) may reduce pain through modulation of the ascending pain signals and/or the central pain-regulating mechanisms. People with persistent neck pain (NP) have also been found to have disturbances in autonomic nervous system (ANS) regulation. A common way to study the ANS is to measure heart rate variability (HRV). It is not known whether deviations in HRV are related to changes in pain perception or to the treatment response to SMT. Commonly, an individual in pain will experience pain reduction when exposed to a second pain stimulus, a mechanism known as conditioned pain modulation (CPM). Patients with persistent pain have been found to have a reduced CPM reaction. It is not known whether this is predictive of treatment response to SMT. The aim of the study is to examine the effects of SMT on HRV and pain. Further, a secondary aim is to test whether a CPM test can be used to predict treatment response in a population of patients with recurrent and persistent NP.Method/designA multicentre randomized controlled clinical trial will be carried out in multidisciplinary primary care clinics. This setting is chosen to minimize bias resulting from patient preference for the treatment modality and provider. The subjects are either self-referred or referred from other health care practitioners locally. The treatment modalities are two well-known interventions for NP; SMT and stretching exercises compared to stretching exercises alone. HRV will be measured using a portable heart monitor. The subjective pain experience will be investigated by assessing pain intensity and the affective quality of pain. CPM will be measured with a standardized cold pressor test. Measurements will be performed three times during a 2-week treatment series.DiscussionThe study will utilize normal clinical procedures, which should aid the transferability and external validity of the results. The study will provide knowledge regarding the underlying mechanisms of the effects of SMT. Furthermore, the study will examine whether a CPM test is predictive of treatment outcome in a population of patients with recurrent and persistent NP.Trial registrationClinicalTrials.gov, NCT03576846 . Registered on 3 July 2018.

Dataset Information

Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial.

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Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial.

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