Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER), a pragmatic trial for conservative chronic low back pain treatment.

BACKGROUND: Chronic low back pain (cLBP) is a common and highly disabling problem world-wide. Although many treatment options exist, it is unclear how to best sequence the multitude of care options to provide the greatest benefit to patients. METHODS: The Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER) trial uses a pragmatic, randomized, stepped design. Enrollment targets 2529 participants from 20 Veterans Affairs (VA) medical centers. Participants with chronic low back pain will first be randomized to one of three options: 1) an internet-based self-management program (Pain EASE); 2) a tailored physical therapy program (Enhanced PT); or 3) continued care with active monitoring (CCAM), a form of usual care. Participants not achieving a 30% or 2-point reduction on the study's primary outcome (Brief Pain Inventory Pain Interference (BPI-PI) subscale), 3 months after beginning treatment may undergo re-randomization in a second step to cognitive behavioral therapy for chronic pain, spinal manipulation therapy, or yoga. Secondary outcomes include pain intensity, back pain-related disability, depression, and others. Participants will be assessed every three months until 12 months after initiating their final trial therapy. Companion economic and implementation analyses are also planned. RESULTS: The SCEPTER trial is currently recruiting and enrolling participants. CONCLUSIONS: Trial results will inform treatment decisions for the stepped management of chronic low back pain - a common and disabling condition. Additional analyses will help tailor treatment selection to individual patient characteristics, promote efficient resource use, and identify implementation barriers of interventions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT04142177.

The reliability of a novel magnetic resonance compatible electro-pneumatic device for delivering a painful pressure stimulus over the lumbar spine.

BACKGROUND: Chronic lower back pain (CLBP) is a significant public health problem in the USA. The complexity of CLBP necessitates an assessment tool that can objectively evaluate the aspects of CLBP that lead to disability. Here we present a novel means by which to provide pressure stimuli to the lumbar spine through the use of an electro-pneumatic circuit that can be used in conjunction with functional magnetic resonance imaging (fMRI) technology to assess the cortical activity changes associated with CLBP. METHODS: A test-retest experimental design was used to objectively quantify pressure pain sensitivity of the lumbar spine. Sensitivity was investigated through the identification of pressure pain thresholds of the lumbar spine using a multiple random staircase method (5-s stimuli) and continuous pain intensity rating (25-s stimuli). RESULTS: Data presented here were consistent and reliable from day to day with an interclass-correlation coefficient (ICC) value of 0.913 for threshold values overall and individual ICC values of 0.652, 0.818, and 0.851 for mild, moderate, and intense thresholds, respectively. Linear regression analysis for longer trials indicated a large variation on day 1, R(2) values ranged from 0.222 to 0.882, however, the number of low correlation values decreased with only three subjects having R(2) < 0.6 for trial 2 on day 2. CONCLUSION: This project has successfully developed a device that can deliver a reliable and reproducible stimulus over the lumbar spine that mimics the palpatory technique used in clinical practice, and can be used in conjunction with fMRI to assess cortical response.

Evaluation of a modified clinical prediction rule for use with spinal manipulative therapy in patients with chronic low back pain: a randomized clinical trial.

BACKGROUND: Spinal Manipulative Therapy (SMT) and Active Exercise Therapy (AET) have both demonstrated efficacy in the treatment of Chronic Lower Back Pain (CLBP). A Clinical Prediction Rule (CPR) for responsiveness to SMT has been validated in a heterogeneous lower back pain population; however there is a need to evaluate this CPR specifically for patients with CLBP, which is a significant source of disability. METHODS: We conducted a randomized controlled trial (RCT) in Veteran Affairs and civilian outpatient clinics evaluating a modification of the original CPR (mCPR) in CLBP, eliminating acute low back pain and altering the specific types of SMT to improve generalizability. We enrolled and followed 181 patients with CLBP from 2007 to 2010. Patients were randomized by status on the mCPR to undergo either SMT or AET twice a week for four weeks. Providers and statisticians were blinded as to mCPR status. We collected outcome measures at 5, 12 and 24-weeks post baseline. We tested our study hypotheses by a general linear model repeated measures procedure following a univariate analysis of covariance approach. Outcome measures included, Visual Analogue Scale, Bodily pain subscale of SF-36 and the Oswestry Disability Index, Patient Satisfaction and Patient Expectation. RESULTS: Of the 89 AET patients, 69 (78%) completed the study and of the 92 SMT patients, 76 (83%) completed the study. As hypothesized, we found main effects of time where the SMT and AET groups showed significant improvements in pain and disability from baseline. There were no differences in treatment outcomes between groups in response to the treatment, given the lack of significant treatment x time interactions. The mCPR x treatment x time interactions were not significant. The differences in outcomes between treatment groups were the same for positive and negative on the mCPR groups, thus our second hypothesis was not supported. CONCLUSIONS: We found no evidence that a modification of the original CPR can be used to discriminate CLBP patients that would benefit more from SMT. Further studies are needed to further clarify the patient characteristics that moderate treatment responsiveness to specific interventions for CLBP. TRIAL REGISTRATION: ISRCTN30511490.

Spinal Manipulative Therapy for Chronic Lower Back Pain in Older Veterans: A Prospective, Randomized, Placebo-Controlled Trial.

INTRODUCTION: Chronic lower back pain (CLBP) is problematic in older veterans. Spinal manipulative therapy (SMT) is commonly utilized for CLBP in older adults, yet there are few randomized placebo-controlled trials evaluating SMT. METHODS: The purpose of the study was to compare the effectiveness of SMT to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics. RESULTS: Older veterans (≥ 65 years of age) who were naive to chiropractic were recruited. A total of 136 were included in the study with 69 being randomly assigned to SMT and 67 to sham intervention. Patients were treated 2 times per week for 4 weeks assessing outcomes at baseline, 5, and 12 weeks postbaseline. Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the SMT group when compared to the sham intervention group. There were no significant differences in adverse events between the groups. CONCLUSIONS: The SMT did not result in greater improvement in pain when compared to our sham intervention; however, SMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.

The role of chiropractic care in older adults.

There are a rising number of older adults; in the US alone nearly 20% of the population will be 65 or older by 2030. Chiropractic is one of the most frequently utilized types of complementary and alternative care by older adults, used by an estimated 5% of older adults in the U.S. annually. Chiropractic care involves many different types of interventions, including preventive strategies. This commentary by experts in the field of geriatrics, discusses the evidence for the use of spinal manipulative therapy, acupuncture, nutritional counseling and fall prevention strategies as delivered by doctors of chiropractic. Given the utilization of chiropractic services by the older adult, it is imperative that providers be familiar with the evidence for and the prudent use of different management strategies for older adults.

Spinal manipulative therapy for elderly patients with chronic obstructive pulmonary disease: a case series.

OBJECTIVE: The objective of this case series is to report the results of spinal manipulative therapy (SMT) for people with chronic obstructive pulmonary disease (COPD) who were older than 65 years. METHODS: The study design was a prospective case series. Six patients of a long-term care center who were older than 65 years and having COPD underwent a course of 12 SMT sessions over a 4-week period. Each SMT session consisted of manually applied spinal manipulation and instrument-assisted spinal manipulation delivered by a doctor of chiropractic. Lung function measurements were recorded at baseline and at 2 and 4 weeks. The occurrence and type of any adverse events (AEs) related to SMT were recorded at each SMT session. RESULTS: One male and 5 female patients took part in the study. The average age was 79.1 years (range, 68-89 years). There was a clinically significant increase in forced expiratory volume in the first second after SMT in 4 of the 6 patients at 2 weeks. This was sustained in only 1 patient at 4 weeks. No clinically significant changes were observed for forced vital capacity at 2 or 4 weeks. One hundred forty-four manually applied spinal manipulations and 72 instrument-assisted spinal manipulations were administered during the intervention period. No major or moderate AEs were reported. Only minor AEs were reported after 29% of the intervention sessions, with 1 AE being reported for each patient. All AEs resolved within 48 hours. CONCLUSIONS: This case series offers preliminary evidence that SMT may have the potential to benefit lung function in patients with COPD who are older than 65 years.

TNF is required for the induction but not the maintenance of compression-induced BME signals in murine tail vertebrae: limitations of anti-TNF therapy for degenerative disc disease.

While bone marrow edema (BME) is diagnostic of spondyloarthropathy, its nature remains poorly understood. In contrast, BME in ankylosing spondylitis is caused by tumor necrosis factor (TNF)-induced vascular and cellular changes. To investigate the relationship between chronic compression and TNF signaling in compression-induced BME we utilized a tail vertebrae compression model with WT, TNF-Tg, and TNFR1&2-/- mice to evaluate: (i) healing following release of chronic compression, (ii) induction of BME in the absence of TNFR, and (iii) efficacy of anti-TNF therapy. Compression-induced normalized marrow contrast enhancement (NMCE) in WT was significantly decreased threefold (p < 0.01) within 2 weeks of release, while the NMCE values in TNF-Tg vertebrae remained elevated, but had a significant decrease (p < 0.05) by 6 weeks after the release of compression. TNFR1&2-/- mice were resistant to compression-induced BME. Anti-TNF therapy did not affect NMCE versus placebo. Histological examination revealed that NMCE values significantly correlated with marrow vascularity and cellularity (p < 0.05), which account for 76% of the variability of NMCE. Collectively, these data demonstrate a critical role for TNF in the induction of chronic compression-induced BME, but not in its maintenance. Amelioration of BME is achieved through biomechanical stability, but is not affected by anti-TNF therapy.

Chronic axial compression of the mouse tail segment induces MRI bone marrow edema changes that correlate with increased marrow vasculature and cellularity.

Magnetic resonance imaging (MRI) of bone marrow edema (BME) has been found to be helpful in the diagnosis of back pain attributed to degenerative disk disease (DDD) and spondyloarthropathy (SA), but its interpretation is limited by a lack of knowledge of its nature and natural history. We assessed effects of compressive forces to mouse tail segments of WT and TNF-Tg mice with SA, via contrast enhanced-MRI and histology. Normalized marrow contrast enhancement (NMCE) of uninstrumented WT vertebrae significantly decrease, threefold (p < 0.01) from 8 to 12 weeks of age, while the NMCE of TNF-Tg vertebrae remained elevated. Compressive loading (6x body weight) increased NMCE twofold (p < 0.02) within 2 weeks in WT tails, which was equal to 6x loaded TNF-Tg tails within 4 weeks. Histology confirmed degenerative changes and that load-induced NMCE corresponded to increased vascular sinus tissue (35 +/- 3% vs. 19 +/- 3%; p < 0.01) and cellularity (4,235 +/- 886 vs.1,468 +/- 320 cells/mm(2); p < 0.01) for the loaded versus unloaded WT, respectively. However, micro-computed tomography (CT) analyses failed to detect significant load-induced changes to bone. While the bone marrow of loaded WT and TNF-Tg vertebrae were similar, histology demonstrated mild cellular infiltrate and increased osteoclastic resorption in the WT tails versus severe inflammatory-erosive arthritis in TNF-Tg joints. Significant (p < 0.05) decreases in cortical and trabecular bone volume in uninstrumented TNF-Tg versus WT vertebrae were confirmed by micro-CT. Thus, chronic load-induced DDD causes BME signals in vertebrae similar to those observed from SA, and both DDD and SA signals correlate with a conversion from yellow to red marrow, with increased vascularity.

Chiropractic and public health: current state and future vision.

This article provides an overview of primary chiropractic issues as they relate to public health. This collaborative summary documents the chiropractic profession's current involvement in public health, reflects on past barriers that may have prevented full participation within the public health movement, and summarizes the relationship of current chiropractic and public health topics. Topics discussed include how the chiropractic profession participates in preventive health services, health promotion, immunization, geriatrics, health care in a military environment, and interdisciplinary care.

A pilot study comparing two manual therapy interventions for carpal tunnel syndrome.

OBJECTIVE: The purpose of this study was to determine the clinical efficacy of manual therapy interventions for relieving the signs and symptoms of carpal tunnel syndrome (CTS) by comparing 2 forms of manual therapy techniques: Graston Instrument-assisted soft tissue mobilization (GISTM) and STM administered with the clinician hands. METHODS: The study was a prospective comparative research design in the setting of a research laboratory. Volunteers were recruited with symptoms suggestive of CTS based upon a phone interview and confirmed by electrodiagnostic study findings, symptom characteristics, and physical examination findings during an initial screening visit. Eligible patients with CTS were randomly allocated to receive either GISTM or STM. Interventions were, on average, twice a week for 4 weeks and once a week for 2 additional weeks. Outcome measures included (1) sensory and motor nerve conduction evaluations of the median nerve; (2) subjective pain evaluations of the hand using visual analog scales and Katz hand diagrams; (3) self-reported ratings of symptom severity and functional status; and (4) clinical assessments of sensory and motor functions of the hand via physical examination procedures. Parametric and nonparametric statistics compared treated CTS hand and control hand and between the treatment interventions, across time (baseline, immediate post, and at 3 months' follow-up). RESULTS: After both manual therapy interventions, there were improvements to nerve conduction latencies, wrist strength, and wrist motion. The improvements detected by our subjective evaluations of the signs and symptoms of CTS and patient satisfaction with the treatment outcomes provided additional evidence for the clinical efficacy of these 2 manual therapies for CTS. The improvements were maintained at 3 months for both treatment interventions. Data from the control hand did not change across measurement time points. CONCLUSIONS: Although the clinical improvements were not different between the 2 manual therapy techniques, which were compared prospectively, the data substantiated the clinical efficacy of conservative treatment options for mild to moderate CTS.

Evaluation of the effect of postural perturbation on motoneuronal activity following various methods of lumbar spinal manipulation.

BACKGROUND AND CONTEXT: One basic physiologic response to spinal manipulation (SM) is a transient decrease in motoneuronal activity, as assessed by the Hoffmann reflex (H-reflex) technique. However, questions of appropriate control procedures when using the H-reflex technique to study the basic physiologic mechanisms of SM still exist. The identification of appropriate control procedures may allow us to better differentiate among the specific and nonspecific aspects of SM. PURPOSE: The purpose of the research was to determine the contributions of postural perturbations on the attenuation of motoneuronal activity following spinal manipulative thrusts and spinal joint preload procedures applied to the lumbar spine. STUDY DESIGN/SETTING: H/M(max) ratios, recorded from the gastrocnemius muscle, were measured before and after lumbar spinal procedures. The experimental designs for the laboratory data collection protocols were repeated measures and between-subjects. PATIENT SAMPLE: The subjects were asymptomatic, young, healthy volunteers. OUTCOME MEASURE: H/M(max) ratios recorded from the gastrocnemius muscle. METHODS: In Experiment 1, the administration of prone lumbar procedures involved either manual assist to more fully shear the lumbar zygapophyseal joints or no manual assist. One set of subjects (n=17) received assisted joint preload force and manipulation, whereas a second set of subjects (n=17) received unassisted joint preload force and manipulation. In a second laboratory experiment, one set of subjects (n=10) received a L5-S1 side-posture SM, whereas a second set of subjects (n=10) were just positioned into side-posture. RESULTS: There was a H/M(max) ratio attenuation of 18.2% after assisted spinal manipulation, whereas H/M(max) ratio attenuation was only 9.5% after unassisted spinal manipulation. Decreases of H/M(max) ratios by 8.5% and 7.5% were observed after assisted and unassisted joint preload forces, respectively. The amount of H/M(max) ratio attenuation was significantly greater immediately after the L5-S1 SM procedure (28.4%) as compared with a side-posture positioning maneuver (15.3%). CONCLUSION: SM may provide procedure-specific sensory input that appears to vary, based upon the various types of vertebral loading applied to the lumbar spine.