Robert D. Vining

Patient-centered outcomes of high-velocity, low-amplitude spinal manipulation for low back pain: A systematic review

Low back pain (LBP) is a well-recognized public health problem with no clear gold standard medical approach to treatment. Thus, those with LBP frequently turn to treatments such as spinal manipulation (SM). Many clinical trials have been conducted to evaluate the efficacy or effectiveness of SM for LBP. The primary objective of this paper was to describe the current literature on patient-centered outcomes following a specific type of commonly used SM, high-velocity low-amplitude (HVLA), in patients with LBP. A systematic search strategy was used to capture all LBP clinical trials of HVLA using our predefined patient-centered outcomes: visual analogue scale, numerical pain rating scale, Roland-Morris Disability Questionnaire, and the Oswestry Low Back Pain Disability Index. Of the 1294 articles identified by our search, 38 met our eligibility criteria. Like previous SM for LBP systematic reviews, this review shows a small but consistent treatment effect at least as large as that seen in other conservative methods of care. The heterogeneity and inconsistency in reporting within the studies reviewed makes it difficult to draw definitive conclusions. Future SM studies for LBP would benefit if some of these issues were addressed by the scientific community before further research in this area is conducted.

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

BackgroundLow back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults.Methods/designThis pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes.DiscussionThis pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain.Trial registrationThis trial registered in ClinicalTrials.gov on 04 March 2011 with the ID number of NCT01312233.

Similar Effects of Thrust and Nonthrust Spinal Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled Trial With Adaptive Allocation.

Study Design. A three-arm controlled trial with adaptive allocation. Objectives. The aim of this study was to compare short-term effects of a side-lying, thrust spinal manipulation (SM) procedure and a nonthrust, flexion-distraction SM procedure in adults with subacute or chronic low back pain (LBP) over 2 weeks. Summary of Background Data. SM has been recommended in recently published clinical guidelines for LBP management. Previous studies suggest that thrust and nonthrust SM procedures, though distinctly different in joint loading characteristics, have similar effects on patients with LBP. Methods. Participants were eligible if they were 21 to 54 years old, had LBP for at least 4 weeks, scored 6 or above on the Roland-Morris disability questionnaire, and met the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force Classification for Spinal Disorders. Participants were allocated in a 3:3:2 ratio to four sessions of thrust or nonthrust SM procedures directed at the lower lumbar and pelvic regions, or to a 2-week wait list control. The primary outcome was LBP-related disability using Roland-Morris Disability Questionnaire and the secondary outcomes were LBP intensity using visual analog scale, Fear-Avoidance Beliefs Questionnaire, and the 36-Item Short Form Health Survey. The study was conducted at the Palmer Center for Chiropractic Research with care provided by experienced doctors of chiropractic. Clinicians and patients were not blinded to treatment group. Results. Of 192 participants enrolled, the mean age was 40 years and 54% were male. Improvement in disability, LBP intensity, Fear-Avoidance Beliefs Questionnaire—work subscale, and 36-Item Short Form Health Survey—physical health summary measure for the two SM groups were significantly greater than the control group. No difference in any outcomes was observed between the two SM groups. Conclusion. Thrust and nonthrust SM procedures with distinctly different joint loading characteristics demonstrated similar effects in short-term LBP improvement and both were superior to a wait list control. Level of Evidence: 2

Prevalence of Radiographic Findings in Individuals With Chronic Low Back Pain Screened for a Randomized Controlled Trial: Secondary Analysis and Clinical Implications

OBJECTIVE The purpose of this study is to measure the prevalence of graded disc degeneration, spondylolisthesis, transitional segmentation, and the distribution of sacral slope in patients 21 to 65 years of age with chronic low back pain (CLBP). METHODS This retrospective study analyzed 247 digital lumbar radiographic series obtained during a randomized controlled trial of chiropractic patients with CLBP. Chronic low back pain was defined as pain in the low back lasting 12 weeks or longer. Radiographic findings of disc degeneration, spondylolisthesis, and lumbosacral transitional segmentation were graded by 2 authors using established classification criteria. Sacral slope was measured with a digital tool contained within imaging software. RESULTS Lumbosacral transitional segments graded I to IV (Castellvi classification) were present in 14% of cases. Lumbar disc degeneration was most prevalent at L3-4 (49%), followed by L4-5 (42%), L2-3 (41%), L5-S1 (37%), and L1-2 (29%). Isthmic spondylolisthesis was present in 5% of cases, with L5 the most common location. Degenerative spondylolisthesis demonstrated a prevalence of 18%, most commonly occurring at L4. The prevalence of degenerative spondylolisthesis was 51% for women aged 50 to 59 years and 24% for men in the same age range. CONCLUSIONS Moderate-severe disc degeneration, multilevel disc narrowing, and degenerative spondylolisthesis were common in individuals with CLBP with age more than 40 years. Isthmic spondylolisthesis was not more prevalent than what has been reported in other populations. Transitional segmentation was identified in a minority of participants, with some of these exhibiting accessory joints or fusion. Mean sacral slope in individuals with CLBP was not substantially different from mean slopes reported in other populations.

Attitudes toward evidence-based clinical practice among doctors of chiropractic with diplomate-level training in orthopedics

BackgroundEvidence-based clinical practice (EBCP) is a practice model gaining prominence within healthcare, including the chiropractic profession. The status of EBCP has been evaluated in a variety of healthcare disciplines, but little is known regarding the attitudes doctors of chiropractic (DCs) hold toward this model of healthcare. This project examines the attitudes toward EBCP within a specialty discipline of DCs.MethodsWe identified a survey questionnaire previously used to evaluate EBCP among non-chiropractic complementary and alternative practitioners. We adapted this questionnaire for use among DCs and pretested it in 5 chiropractic college faculty. The final version was administered to DCs with diplomate-level training in orthopedics. The survey was emailed to 299 potential participants; descriptive results were calculated.Results144 surveys were returned, resulting in a 48% response rate. The majority of respondents perceived EBCP as an important aspect of chiropractic practice. Respondents also believed themselves to have an above average skill level in EBCP, reported that training originated from their diplomate education, and based the majority of their practice on clinical research.ConclusionDoctors of chiropractic with an orthopedic diplomate appear to have favorable attitudes toward EBCP. Further study will help understand EBCP perceptions among general field DCs. A logical next step includes validation of this questionnaire.

Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical Care Alone on Pain and Disability Among US Service Members With Low Back Pain: A Comparative Effectiveness Clinical Trial

Importance It is critically important to evaluate the effect of nonpharmacological treatments on low back pain and associated disability. Objective To determine whether the addition of chiropractic care to usual medical care results in better pain relief and pain-related function when compared with usual medical care alone. Design, Setting, and Participants A 3-site pragmatic comparative effectiveness clinical trial using adaptive allocation was conducted from September 28, 2012, to February 13, 2016, at 2 large military medical centers in major metropolitan areas and 1 smaller hospital at a military training site. Eligible participants were active-duty US service members aged 18 to 50 years with low back pain from a musculoskeletal source. Interventions The intervention period was 6 weeks. Usual medical care included self-care, medications, physical therapy, and pain clinic referral. Chiropractic care included spinal manipulative therapy in the low back and adjacent regions and additional therapeutic procedures such as rehabilitative exercise, cryotherapy, superficial heat, and other manual therapies. Main Outcomes and Measures Coprimary outcomes were low back pain intensity (Numerical Rating Scale; scores ranging from 0 [no low back pain] to 10 [worst possible low back pain]) and disability (Roland Morris Disability Questionnaire; scores ranging from 0-24, with higher scores indicating greater disability) at 6 weeks. Secondary outcomes included perceived improvement, satisfaction (Numerical Rating Scale; scores ranging from 0 [not at all satisfied] to 10 [extremely satisfied]), and medication use. The coprimary outcomes were modeled with linear mixed-effects regression over baseline and weeks 2, 4, 6, and 12. Results Of the 806 screened patients who were recruited through either clinician referrals or self-referrals, 750 were enrolled (250 at each site). The mean (SD) participant age was 30.9 (8.7) years, 175 participants (23.3%) were female, and 243 participants (32.4%) were nonwhite. Statistically significant site × time × group interactions were found in all models. Adjusted mean differences in scores at week 6 were statistically significant in favor of usual medical care plus chiropractic care compared with usual medical care alone overall for low back pain intensity (mean difference, −1.1; 95% CI, −1.4 to −0.7), disability (mean difference, −2.2; 95% CI, −3.1 to −1.2), and satisfaction (mean difference, 2.5; 95% CI, 2.1 to 2.8) as well as at each site. Adjusted odd ratios at week 6 were also statistically significant in favor of usual medical care plus chiropractic care overall for perceived improvement (odds ratio = 0.18; 95% CI, 0.13-0.25) and self-reported pain medication use (odds ratio = 0.73; 95% CI, 0.54-0.97). No serious related adverse events were reported. Conclusions and Relevance Chiropractic care, when added to usual medical care, resulted in moderate short-term improvements in low back pain intensity and disability in active-duty military personnel. This trial provides additional support for the inclusion of chiropractic care as a component of multidisciplinary health care for low back pain, as currently recommended in existing guidelines. However, study limitations illustrate that further research is needed to understand longer-term outcomes as well as how patient heterogeneity and intervention variations affect patient responses to chiropractic care. Trial Registration ClinicalTrials.gov Identifier: NCT01692275

Training and certification of doctors of chiropractic in delivering manual cervical traction forces: Results of a longitudinal observational study.

Objective : Doctors of chiropractic (DCs) use manual cervical distraction to treat patients with neck pain. Previous research demonstrates variability in traction forces generated by different DCs. This article reports on a training protocol and monthly certification process using bioengineering technology to standardize cervical traction force delivery among clinicians. Methods : This longitudinal observational study evaluated a training and certification process for DCs who provided force-based manual cervical distraction during a randomized clinical trial. The DCs completed a 7-week initial training that included instructional lectures, observation, and guided practice by a clinical expert, followed by 3 hours of weekly practice sessions delivering the technique to asymptomatic volunteers who served as simulated patients. An instrument-modified table and computer software provided the DCs with real-time audible and visual feedback on the traction forces they generated and graphical displays of the magnitude of traction forces as a function of time immediately after the delivery of the treatment. The DCs completed monthly certifications on traction force delivery throughout the trial. Descriptive accounts of certification attempts are provided. Results : Two DCs achieved certification in traction force delivery over 10 consecutive months. No certification required more than 3 attempts at C5 and occiput contacts for 3 force ranges (0-20 N, 21-50 N, and 51-100 N). Conclusions : This study demonstrates the feasibility of a training protocol and certification process using bioengineering technology for training DCs to deliver manual cervical distraction within specified traction force ranges over a 10-month period.

Study protocol for patient response to spinal manipulation – a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain

BackgroundLow back pain (LBP) is a major health issue due to its high prevalence rate and socioeconomic cost. While spinal manipulation (SM) is recommended for LBP treatment by recently published clinical guidelines, the underlying therapeutic mechanisms remain unclear. Spinal stiffness is routinely examined and used in clinical decisions for SM delivery. It has also been explored as a predictor for clinical improvement. Flexion-relaxation phenomenon has been demonstrated to distinguish between LBP and healthy populations. The primary objective of the current study is to collect preliminary estimates of variability and effect size for the associations of these two physiological measures with patient-centered outcomes in chronic LBP patients. Additionally biomechanical characteristics of SM delivery are collected with the intention to explore the potential dose–response relationship between SM and LBP improvement.Methods/DesignThis is a prospective, observational study applying side-lying, high velocity, low amplitude SM as treatment for patients with LBP over a course of 6 weeks. Approximately 80 participants will be enrolled if they present with chronic LBP of 1, 2 or 3 in Quebec Task Force Classification for spinal disorders, a Roland-Morris Disability Questionnaire (RMDQ) score ≥ 6, and persistent LBP ≥ 2 with a maximum ≥ 4 using numerical rating scale. Patient-centered outcomes include LBP using visual analog scale, RMDQ, and PROMIS-29. Lumbar spine stiffness is assessed using palpation, a hand-held instrumented device, and an automated device. Flexion-relaxation is assessed using surface electromyography at the third level of the lumbar spine. Biomechanical characteristics of SM are assessed using a self-reported, itemized description system, as well as advanced kinetic measures that will be applied to estimate forces and moments at the lumbar segment level targeted by SM.DiscussionBeside alterations in material properties of the passive components of the spine, increased neuromuscular activity may also contribute to a stiffened spine. Examining changes in both spinal stiffness and flexion-relaxation along the course of the treatment provides an opportunity to understand if the therapeutic effect of SM is associated with its action on active and/or passive components of the spine.Trial registrationNCT01670292 on clinicaltrials.gov.

DEVELOPMENT OF FORCE-FEEDBACK TECHNOLOGY FOR TRAINING CLINICIANS TO DELIVER MANUAL CERVICAL DISTRACTION

Objective: Neck pain is a prevalent musculoskeletal (MSK) complaint and costly societal burden. Doctors of chiropractic (DCs) provide manual therapies for neck pain patients to relieve discomfort and improve physical function. Manual cervical distraction (MCD) is a chiropractic procedure for neck pain. During MCD, the patient lies face down on a specially designed chiropractic table. The DC gently moves the head and neck in a cephalic direction while holding a gentle broad manual contact over the posterior neck, to create traction effects. MCD traction force profiles vary between clinicians making standardization of treatment delivery challenging. This paper reports on a bioengineering technology developed to provide clinicians with auditory and graphical feedback on the magnitude of cervical traction forces applied during MCD to simulated patients during training for a randomized controlled trial (RCT). Methods: The Cox flexion-distraction chiropractic table is designed with a moveable headpiece. The table allows for long axis horizontal movement of the head and neck, while the patient’s trunk and legs rest on fixed table sections. We instrument-modified this table with three-dimensional force transducers to measure the traction forces applied by the doctor. Motion Monitor software collects data from force transducers. The software displays the magnitude of traction forces graphically as a function of time. Real-time audible feedback produces a steady tone when measured traction forces are <20N, no tone when forces range between 20-50N, and an audible tone when forces exceed 50N. Peer debriefing from simulated patients reinforces traction force data from the bioengineering technology.

P03.09. Development of an interprofessional model of collaborative care by doctors of chiropractic and medical doctors for older adults with low back pain

Purpose Although low back pain (LBP) is a common reason older adults seek treatment from either medical doctors (MD/DO) or doctors of chiropractic (DC), collaborative care between these providers is rarely reported. The purpose of our study is to develop a model for such collaborative care in LBP patients, based upon an existing integrative medicine model (Hsiao et al., 2006), focusing on four facets of interprofessional collaboration: attitudes, knowledge, referral, and integrative practice.