Assessment of forces during side-posture adjustment with the use of a table-embedded force plate: Reference values for education.

OBJECTIVE: Force-sensing treatment tables are becoming more commonly used by chiropractic educational institutions. However, when a table-embedded force platform is the sole measurement method, there is little information available about what force-time values instructors and students should expect for side-posture spinal manipulative thrusts. The purpose of this report is to provide force-time values recorded with such a system during side-posture manipulation with human recipients. METHODS: Student volunteers were examined by and received lumbar or pelvic side-posture manipulation from experienced chiropractors who were diplomates of the Gonstead Clinical Studies Society. Forces were recorded using proprietary software of a Bertec force platform; force and time data were analyzed with a custom-programmed software tool in Excel. RESULTS: Seven doctors of chiropractic performed 24 thrusts on 23 student recipients. Preload forces, averaging 69.7 N, and thrust loading duration, averaging 167 milliseconds, were similar to previous studies of side-posture manipulation. Peak loads were higher than previous studies, averaging 1010.9 N. Other variables included prethrust liftoff force, times from thrust onset to peak force and peak load to resolution of thrust, and average rates of force loading and unloading. CONCLUSION: The values we found will be used for reference at our institution and may be useful to instructors at other chiropractic educational institutions, in the teaching of lumbar side-posture manipulation. A caveat is that the values of this study reflect multiple sources of applied force, not solely the force applied directly to the spine.

Spinal Kinematic Assessment of Chiropractic Side-Posture Adjustments: Development of a Motion Capture System.

OBJECTIVE: The purpose of this study was to develop a protocol and a data analysis system for the assessment of postures and movements of doctors of chiropractic during side-posture adjustments (SPAs), otherwise known as side-posture chiropractic spinal manipulation. METHODS: For this study, an experienced chiropractor performed Gonstead-style lumbar SPAs on 10 participants. We used an inertial measurement unit system to record spinal angular motions and analyzed data with a custom application written in Microsoft Excel. RESULTS: Data collection was successful for all trials. We identified postural angles at the time of set-up and thrust and maximum and minimum angles in a period centered on the thrust. All spinal regions of the chiropractor were flexed during the entire period; otherwise, movement patterns were characterized by biphasic wavelike motions, which begin before the time of the thrust and finish afterward. Within each region and plane of motion, patterns were qualitatively similar between participants, but time of thrust was not consistent within the patterns. There was a wide range of angular velocities, and the fastest was measured in the chiropractor's cervical and thoracic regions. CONCLUSION: In this study, we developed a protocol and a data analysis system for assessment of chiropractors' postures and movements during SPAs. The protocol may be useful to future investigators who wish to use similar methods for educational purposes or to examine the role of optimal or suboptimal movement patterns in occupational injuries of doctors of chiropractic.

Development of a mannequin lab for clinical training in a chiropractic program.

OBJECTIVE: Faced with COVID-19 safety protocols that severely limited the ability to conduct chiropractic technique instruction in the usual manner, our university invested the resources to develop a new mannequin lab for hands-on training, which would help supplement the loss of person-to-person contact. METHODS: Training mannequins could enable student learning of palpation and adjustment skills while avoiding close human-human contact. The university had developed a mannequin over the previous 4 years consisting of a full-sized human torso with individually movable and palpable vertebrae, pelvis, and thighs. In the mannequin, 64 pressure sensors are attached to particular vertebral and skeletal landmarks and provide feedback on palpation location and level of force applied. We assembled 3 teams to produce 20 copies of that mannequin for student use. RESULTS: Mannequins were produced in 7 weeks, and space was built out for a special lab. Faculty members are developing classroom procedures to introduce the mannequin to students, phase in the skills from static and motion palpation, and practice thrust performance. CONCLUSION: The production run was successful, and the resulting equipment, well-received by students and faculty. In addition to helping teach manual skills, the lab serves as a platform for educational research to test the efficacy of mannequin-based training protocols. With the pressure sensors on known locations along the spine, future research may be able to test the ability of students to identify and contact specific target locations for adjustive thrusts.

Angular Kinematics of Chiropractic Supine Cervical Spine Manipulation: Rotational Measures and Comparisons to Doctor and Recipient Perceptions.

OBJECTIVES: The primary purposes of this study were to measure axial rotation during supine cervical spinal manipulative therapy (cSMT) and to record recipients' and doctors' perceptions of rotational magnitudes. METHODS: Experienced doctors of chiropractic (DCs) provided supine cSMT and acted as recipients of cSMT. Participants who received SMT wore inertial measurement units attached to the forehead and sternum for motion capture. Afterward, recipients and DCs completed questionnaires asking about their perceptions of motion. Data were analyzed for magnitudes of axial rotation at peak thrust and correlations with patient and doctor perceptions. Secondary analyses included angular velocity, angular acceleration, and other kinematic variables. RESULTS: We recorded 23 SMT events with 14 DCs. Rotation at thrust peaks averaged 32.4° (17.4°). Doctors' and recipients' perceptions of rotation were higher than measured values 45% and 50% of the time, respectively. Maximum angular velocity and acceleration averaged 221.9°/s (124.9) and 4786.5°/s2 (2456.6), respectively. We found no correlation between perceptions and velocity or acceleration; doctors' perceptions had an inverse correlation with measurements. CONCLUSION: On average, we found rotation during supine cSMT to be 32°. Both DCs and SMT recipients overestimated rotation compared with actual measurements. These factors should be considered in discussions of rotation and SMT.

Assessing the feasibility of using an electronic records database system in use in a group of private chiropractic clinics for practice-based research.

OBJECTIVE: To explore the feasibility of collecting aggregated patient data from the electronic records of a group of private practices and to determine the suitability of the data for comparative effectiveness or other practice-based research (PBR). METHODS: Assess the type and quality of healthrelated variables contained in a commercially available electronic records system (Vitalogics) in use in consenting chiropractor's offices. Descriptively analyze baseline patient records to identify demographic variables, vital signs, case types and diagnoses. RESULTS: Of the 46,000 individual patient records that were analyzed, only a fraction had usable demographic data while more than half contained ICD-9 codes, including records for non-insurance case-types. None contained outcome variables. CONCLUSION: We did not find that the electronic record system we examined had the types of demographic and outcomes variables that would be useful for comparative effectiveness research. The addition of special fields to code chief complaint and health status indicators not typically included in an electronic records system would be most useful.

OBJECTIF: Examiner la possibilité de recueillir des macrodonnées de patients dans les dossiers électroniques d'un groupe de cliniques privées et déterminer leur utilité pour mener une recherche comparative d'efficacité ou mener d'autres recherches fondées sur la pratique. MÉTHODOLOGIE: Évaluer le type et la qualité des variables de santé contenus dans le logiciel de gestion de dossiers médicaux informatisés de Vitalogics en usage dans les cabinets des chiropraticiens consentants. Effectuer une analyse descriptive de dossiers de patients de référence pour trouver des variables démographiques, des signes vitaux, des cas types et des diagnostics. RÉSULTATS: Des 46 000 dossiers de patients examinés, seule une partie contenaient des données démographiques utiles alors que moins de la moitié contenaient les codes de la classification ICD-9, et des données sur des cas types non assurés. Aucun ne contenait de variables de résultats. CONCLUSION: À notre avis, le système de gestion de dossiers électroniques examinés ne fournit pas des types de variables démographiques et de variables de résultats qui seraient utiles pour mener une recherche comparative d'efficacité. L'ajout de champs spéciaux permettant de saisir le code du symptôme principal et des indicateurs de l'état de santé, ce qui d'habitude ne se trouve pas dans un logiciel de gestion de dossiers électroniques, s'avérerait très utile.

Mechanical properties of a thoracic spine mannequin with variable stiffness control.

OBJECTIVE: To test the posterior-to-anterior stiffness (PAS) of a new thoracic spine training simulator under different conditions of "fixation." METHODS: We constructed a thoracic spine model using plastic bones and ribs mounted in a wooden box, with skin and soft tissue simulated by layers of silicone and foam. The spine segment could be stiffened with tension applied to cords running through the vertebrae and ribs. We tested PAS at 2 tension levels using a custom-built device to apply repetitive loads at the T6 spinous process (SP) and over adjacent soft tissue (TP) while measuring load and displacement. Stiffness was the slope of the force-displacement curve from 55 to 75 N. RESULTS: Stiffness in the unconstrained (zero tension) condition over the SP averaged 11.98 N/mm and 6.72 N/mm over the TP. With tension applied, SP stiffness increased to 14.56 N/mm, and TP decreased to 6.15 N/mm. CONCLUSION: Thoracic model compliance was similar to that reported for humans. The tension control system increased stiffness by 21.3% only over the SP. Stiffness over the TP was dominated by the lower stiffness of the thicker foam layer and did not change. The mannequin with these properties may be suitable for use in manual training of adjusting or PAS testing skills.

Changes in adjustment force, speed, and direction factors in chiropractic students after 10 weeks undergoing standard technique training.

OBJECTIVE: To assess the force profiles of high-velocity low-amplitude thrusts delivered to a mannequin on a force platform by novice students given only verbal instructions. METHODS: Student volunteers untrained in adjusting delivered a series of adjustments to a mannequin on a force platform. Participants performed 3 light, 3 normal, and 3 heavy thrusts on 5 listings specifying contact point, hand, and direction. Force profiles were analyzed for speed and amplitude, consistency, and force discrimination. Two recording sessions occurred 10 weeks apart. RESULTS: Sixteen participants (11 females, 5 male) completed the study. Peak forces ranged from 880 to 202 N for heavy thrusts and 322- to 66 N for light thrusts. Thrust rate was from 8.1 to 1.8 Newtons per millisecond. Average coefficients of variability (CV = STD/mean) at each load level (initial/final) were heavy: 17%/15%; normal: 16%/15%; and light: 20%/20%, with 0 as ideal. A force ratio measured students' abilities to distinguish thrust magnitude. The heavy/normal ratio (initial/final) was 1.35/1.39, and the light/normal ratio was 0.70/0.67. CONCLUSIONS: At this point, without force feedback being used in the classroom, novice students can produce thrusts that look like those of their teachers and of experienced practitioners, but they may not produce similar speed and force values. They are consistent within and between sessions and can discriminate between light and heavy loads. A natural next step in our educational research will be to measure adjustment factors on more experienced cohorts of students with and without the presence of force-feedback training apparatus.

Thrust Magnitudes, Rates, and 3-Dimensional Directions Delivered in Simulated Lumbar Spine High-Velocity, Low-Amplitude Manipulation.

OBJECTIVES: The purpose of this study was to measure faculty performance of simulated spinal manipulation on a mannequin to help identify teaching standards. METHODS: We measured 3-dimensional transmitted loads using a force plate mounted in the table. Thrusts were delivered through a compliant, jointed mannequin by faculty members along predefined "listings" as taught in lumbopelvic technique courses. RESULTS: Eleven chiropractic faculty members participated, delivering 9 thrusts at 3 loads (light, moderate, and heavy) along 9 different prone and side-posture listings, totaling 81 thrusts per participant. Single-hand Gonstead-style thrusts had variability in magnitude across participants and loads: light thrusts averaged 365 N (95% confidence interval [CI] 327-402), moderate thrusts 454 N (421-487), and heavy thrusts 682 N (623-740). All faculty members could easily distinguish the loads within their performances, but there was some crossover of load levels between participants. Thrust rates averaged 3.55 N/ms (95% CI 3.29-3.82). The dominant vector of prone thrusts was in the z direction (vertically downward), but side-to-side and inferior-to-superior vector components occurred. CONCLUSION: Faculty member performance of simulated spinal manipulation indicated that they are able to control the thrust magnitude and rate as well as direction. In this sample, there was significant variability in peak loads between participants, which needs to be considered in student learning standards. These findings may be useful in translating the understanding of force characteristics to the technique teaching lab.

Low Back Pain Response to Pelvic Tilt Position: An Observational Study of Chiropractic Patients.

OBJECTIVE: The aim of this study was to look for differences between patients with an increased pain response as compared with those with a decreased pain response. METHODS: Data were collected from consecutive new patients with lumbar or lumbopelvic pain in a chiropractic clinic. A pelvic tilt exercise was included in the initial examination, and pain response was noted. Analysis was made of pain and disability severity, as well as symptom location, chronicity, and other characteristics, before and after a course of chiropractic care. RESULTS: Patients with an increased pain response to pelvic tilt (n = 12) had higher levels of pain and disability at baseline than patients without (n = 34). There were no between-group differences in other aspects of their complaints; in age, sex, or body mass; or in the types of care they received (eg, manipulation, stretching, exercise instruction). On the average, both groups of patients showed improvement with chiropractic care, and there was no detectable difference in improvement between groups. CONCLUSIONS: This study found that patients experiencing pain in response to a pelvic tilt maneuver may have a poorer precare status than patients with a decreased pain response.

Establishing force and speed training targets for lumbar spine high-velocity, low-amplitude chiropractic adjustments.

OBJECTIVE: We developed an adjusting bench with a force plate supporting the lumbar portion to measure loads transmitted during lumbar manual adjustment. It will be used to provide force-feedback to enhance student learning in technique labs. The study goal is to define the learning target loads and speeds, with instructors as expert models. METHODS: A total of 11 faculty members experienced in teaching Gonstead technique methods performed 81 simulated adjustments on a mannequin on the force plate. Adjustments were along 9 lumbopelvic "listings" at 3 load levels: light, normal, and heavy. We analyzed the thrusts to find preload, peak load, duration, and thrust rate. RESULTS: Analysis of 891 thrusts showed wide variations between doctors. Peak loads ranged from 100 to 1400 N. All doctors showed clear distinctions between peak load levels, but there was overlap between high and low loads. Thrust rates were more uniform across doctors, averaging 3 N/ms. CONCLUSION: These faculty members delivered a range of thrusts, not unlike those seen in the literature for high velocity, low amplitude manipulation. We have established at least minimum force and speed targets for student performance, but more work must be done to create a normative adjustment to guide refinement of student learning.

Effects of spinal manipulation on sensorimotor function in low back pain patients--A randomised controlled trial.

BACKGROUND: Low back pain (LBP) is a major health problem in industrialized societies. Spinal manipulation (SM) is often used for treating LBP, though the therapeutic mechanisms remain elusive. Research suggests that sensorimotor changes may be involved in LBP. It is hypothesized that SM may generate its beneficial effects by affecting sensorimotor functions. OBJECTIVES: To compare changes in sensorimotor function, as measured by postural sway and response to sudden load, in LBP patients following the delivery of high-velocity low amplitude (HVLA)-SM or low-velocity variable amplitude (LVVA)-SM versus a sham control intervention. DESIGN: A three-arm (1:1:1 ratio) randomized controlled trial. METHODS: A total of 221 participants who were between 21 and 65 years, having LBP intensity (numerical rating scale) ≥4 at either phone screen or the first baseline visit and ≥2 at phone screen and both baseline visits, and Quebec Task Force diagnostic classifications of 1, 2, 3 or 7 were enrolled to receive four SM treatments over two weeks. Study outcomes were measured at the first and fifth visits with the examiners blinded from participant group assignment. RESULTS: The LVVA-SM group demonstrated a significant increase in medial-to-lateral postural excursion on the soft surface at the first visit when compared to the control group. No other significant between-group differences were found for the two sensorimotor tests, whether during the first visit or over two weeks. CONCLUSIONS: It appears that short-term SM does not affect the sensorimotor functions as measured by postural sway and response to sudden load in this study.

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.

Force-time profile differences in the delivery of simulated toggle-recoil spinal manipulation by students, instructors, and field doctors of chiropractic.

OBJECTIVES: The objectives of this study were to examine the force-time profiles of toggle recoil using an instrumented simulator to objectively measure and evaluate students' skill to determine if they become quicker and use less force during the course of their training and to compare them to course instructors and to field doctors of chiropractic (DCs) who use this specific technique in their practices. METHODS: A load cell was placed within a toggle recoil training device. The preload, speed, and magnitude of the toggle recoil thrusts were measured from 60 students, 2 instructors, and 77 DCs (ie, who use the toggle recoil technique in their regular practice). Student data were collected 3 times during their toggle course (after first exposure, at midterm, and at course end.) RESULTS: Thrusts showed a dual-peak force-time profile not previously described in other forms of spinal manipulation. There was a wide range of values for each quantity measured within and between all 3 subject groups. The median peak load for students decreased over the course of their class, but they became slower. Field doctors were faster than students or instructors and delivered higher peak loads. CONCLUSION: Toggle recoil thrusts into a dropping mechanism varied based upon subject and amount of time practicing the task. As students progressed through the class, speed reduced as they increased control to lower peak loads. In the group studies, field DCs applied higher forces and were faster than both students and instructors. There appears to be a unique 2-peak feature of the force-time plot that is unique to toggle recoil manipulation with a drop mechanism.

Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study.

STUDY DESIGN: Randomized controlled trial. OBJECTIVE: To assess changes in pain levels and physical functioning in response to standard medical care (SMC) versus SMC plus chiropractic manipulative therapy (CMT) for the treatment of low back pain (LBP) among 18 to 35-year-old active-duty military personnel. SUMMARY OF BACKGROUND DATA: LBP is common, costly, and a significant cause of long-term sick leave and work loss. Many different interventions are available, but there exists no consensus on the best approach. One intervention often used is manipulative therapy. Current evidence from randomized controlled trials demonstrates that manipulative therapy may be as effective as other conservative treatments of LBP, but its appropriate role in the healthcare delivery system has not been established. METHODS: Prospective, 2-arm randomized controlled trial pilot study comparing SMC plus CMT with only SMC. The primary outcome measures were changes in back-related pain on the numerical rating scale and physical functioning at 4 weeks on the Roland-Morris Disability Questionnaire and back pain functional scale (BPFS). RESULTS: Mean Roland-Morris Disability Questionnaire scores decreased in both groups during the course of the study, but adjusted mean scores were significantly better in the SMC plus CMT group than in the SMC group at both week 2 (P < 0.001) and week 4 (P = 0.004). Mean numerical rating scale pain scores were also significantly better in the group that received CMT. Adjusted mean back pain functional scale scores were significantly higher (improved) in the SMC plus CMT group than in the SMC group at both week 2 (P < 0.001) and week 4 (P = 0.004). CONCLUSION: The results of this trial suggest that CMT in conjunction with SMC offers a significant advantage for decreasing pain and improving physical functioning when compared with only standard care, for men and women between 18 and 35 years of age with acute LBP.

Paraspinal muscle function assessed with the flexion-relaxation ratio at baseline in a population of patients with back-related leg pain.

OBJECTIVE: The purpose of this study was to assess back muscle status at baseline in patients with back-related leg pain (BRLP) and to correlate those findings with baseline demographic and clinical factors. METHODS: Surface electromyography (EMG) and electromagnetic motion-tracking detected flexion-relaxation response in 135 patients with BRLP. Surface EMG electrodes were attached with standard skin preparation over the right and left paraspinal muscles at L3. Participants moved from upright standing into full forward flexion, rested flexed for 1 second, and returned to the upright position. A flexion-relaxation ratio (FRR) factor was calculated as the root mean square EMG amplitude during forward flexion divided by the activity at full flexion. RESULTS: High repeatability was found (intraclass correlation coefficient [ICC]([1,3]) = 0.94 and 0.86) between 3 cycles of assessment at the same session. Patients with BRLP exhibited low FRR values, indicating a loss of the flexion-relaxation response similar to that seen in low back pain patients. Patients with very low FRR had higher Roland-Morris Disability Questionnaire scores than the other patients, had increased incidence of straight leg raise test, and had decreased range and rate of forward flexion. CONCLUSIONS: A subgroup of patients with BRLP was identified with very low FRR who exhibited more disability and clinical findings and decreased motion. The use of the inverted FRR factor, expressing muscle activity at the fully flexed and resting position as a percentage of peak activity during flexion, provides more stable numerical behavior and another perspective on interpreting FRRs.

Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial.

BACKGROUND: Low back pain (LBP) is a recognized public health problem, impacting up to 80% of US adults at some point in their lives. Patients with LBP are utilizing integrative health care such as spinal manipulation (SM). SM is the therapeutic application of a load to specific body tissues or structures and can be divided into two broad categories: SM with a high-velocity low-amplitude load, or an impulse "thrust", (HVLA-SM) and SM with a low-velocity variable-amplitude load (LVVA-SM). There is evidence that sensorimotor function in people with LBP is altered. This study evaluates the sensorimotor function in the lumbopelvic region, as measured by postural sway, response to sudden load and repositioning accuracy, following SM to the lumbar and pelvic region when compared to a sham treatment. METHODS/DESIGN: A total of 219 participants with acute, subacute or chronic low back pain are being recruited from the Quad Cities area located in Iowa and Illinois. They are allocated through a minimization algorithm in a 1:1:1 ratio to receive either 13 HVLA-SM treatments over 6 weeks, 13 LVVA-SM treatments over 6 weeks or 2 weeks of a sham treatment followed by 4 weeks of full spine "doctor's choice" SM. Sensorimotor function tests are performed before and immediately after treatment at baseline, week 2 and week 6. Self-report outcome assessments are also collected. The primary aims of this study are to 1) determine immediate pre to post changes in sensorimotor function as measured by postural sway following delivery of a single HVLA-SM or LVVA-SM treatment when compared to a sham treatment and 2) to determine changes from baseline to 2 weeks (4 treatments) of HVLA-SM or LVVA-SM compared to a sham treatment. Secondary aims include changes in response to sudden loads and lumbar repositioning accuracy at these endpoints, estimating sensorimotor function in the SM groups after 6 weeks of treatment, and exploring if changes in sensorimotor function are associated with changes in self-report outcome assessments. DISCUSSION: This study may provide clues to the sensorimotor mechanisms that explain observed functional deficits associated with LBP, as well as the mechanism of action of SM. TRIAL REGISTRATION: This trial is registered in ClinicalTrials.gov, with the ID number of NCT00830596, registered on January 27, 2009. The first participant was allocated on 30 January 2009 and the final participant was allocated on 17 March 2011.

Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial.

BACKGROUND CONTEXT: Several conservative therapies have been shown to be beneficial in the treatment of chronic low back pain (CLBP), including different forms of exercise and spinal manipulative therapy (SMT). The efficacy of less time-consuming and less costly self-care interventions, for example, home exercise, remains inconclusive in CLBP populations. PURPOSE: The purpose of this study was to assess the relative efficacy of supervised exercise, spinal manipulation, and home exercise for the treatment of CLBP. STUDY DESIGN/SETTING: An observer-blinded and mixed-method randomized clinical trial conducted in a university research clinic in Bloomington, MN, USA. PATIENT SAMPLE: Individuals, 18 to 65 years of age, who had a primary complaint of mechanical LBP of at least 6-week duration with or without radiating pain to the lower extremity were included in this trial. OUTCOME MEASURES: Patient-rated outcomes were pain, disability, general health status, medication use, global improvement, and satisfaction. Trunk muscle endurance and strength were assessed by blinded examiners, and qualitative interviews were performed at the end of the 12-week treatment phase. METHODS: This prospective randomized clinical trial examined the short- (12 weeks) and long-term (52 weeks) relative efficacy of high-dose, supervised low-tech trunk exercise, chiropractic SMT, and a short course of home exercise and self-care advice for the treatment of LBP of at least 6-week duration. The study was approved by local institutional review boards. RESULTS: A total of 301 individuals were included in this trial. For all three treatment groups, outcomes improved during the 12 weeks of treatment. Those who received supervised trunk exercise were most satisfied with care and experienced the greatest gains in trunk muscle endurance and strength, but they did not significantly differ from those receiving chiropractic spinal manipulation or home exercise in terms of pain and other patient-rated individual outcomes, in both the short- and long-term. CONCLUSIONS: For CLBP, supervised exercise was significantly better than chiropractic spinal manipulation and home exercise in terms of satisfaction with treatment and trunk muscle endurance and strength. Although the short- and long-term differences between groups in patient-rated pain, disability, improvement, general health status, and medication use consistently favored the supervised exercise group, the differences were relatively small and not statistically significant for these individual outcomes.

Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial.

BACKGROUND: Back-related leg pain (BRLP) is a common variation of low back pain (LBP), with lifetime prevalence estimates as high as 40%. Often disabling, BRLP accounts for greater work loss, recurrences, and higher costs than uncomplicated LBP and more often leads to surgery with a lifetime incidence of 10% for those with severe BRLP, compared to 1-2% for those with LBP.In the US, half of those with back-related conditions seek CAM treatments, the most common of which is chiropractic care. While there is preliminary evidence suggesting chiropractic spinal manipulative therapy is beneficial for patients with BRLP, there is insufficient evidence currently available to assess the effectiveness of this care. METHODS/DESIGN: This study is a two-site, prospective, parallel group, observer-blinded randomized clinical trial (RCT). A total of 192 study patients will be recruited from the Twin Cities, MN (n = 122) and Quad Cities area in Iowa and Illinois (n = 70) to the research clinics at WHCCS and PCCR, respectively.It compares two interventions: chiropractic spinal manipulative therapy (SMT) plus home exercise program (HEP) to HEP alone (minimal intervention comparison) for patients with subacute or chronic back-related leg pain. DISCUSSION: Back-related leg pain (BRLP) is a costly and often disabling variation of the ubiquitous back pain conditions. As health care costs continue to climb, the search for effective treatments with few side-effects is critical. While SMT is the most commonly sought CAM treatment for LBP sufferers, there is only a small, albeit promising, body of research to support its use for patients with BRLP.This study seeks to fill a critical gap in the LBP literature by performing the first full scale RCT assessing chiropractic SMT for patients with sub-acute or chronic BRLP using important patient-oriented and objective biomechanical outcome measures. TRIAL REGISTRATION: ClinicalTrials.gov NCT00494065.

Comparison of posteroanterior spinal stiffness measures to clinical and demographic findings at baseline in patients enrolled in a clinical study of spinal manipulation for low back pain.

OBJECTIVE: A system for measuring posterior-to-anterior spinal stiffness (PAS) was developed for use in clinical trials of manipulation for low back pain (LBP). The current report is an analysis of the baseline PAS data, with particular emphasis on relationships between PAS and clinical and demographic characteristics. METHODS: Posterior-to-anterior spinal stiffness measurements were recorded over the spinous processes of the lumbar spines from patients who had LBP. The system uses electronic sensors to record displacement and force, whereas a human operator provides the force of indentation. Clinical and outcome measures were compared with spinal stiffness. RESULTS: We recruited 192 patients (89 female and 103 male; average age, 40.0 years; SD, 9.4 years). The average Roland-Morris score was 9.7 (SD, 3.2) on a 24-point scale. The Visual Analog Scale pain scores were 55.7 (SD, 20.9) on a 100-mm scale. Stiffness values ranged from 4.16 to 39.68 N/mm (mean, 10.80 N/mm; SD, 3.72 N/mm). Females' lumbar spines were, on the average, 2 N/mm more compliant than males (P < .001). CONCLUSIONS: The PAS system of computer-monitored equipment with human operation performed well in this clinical study of LBP. Spinal stiffness was found to be different between males and females, and age and body mass index were related to PAS. We found no significant relationship between the severity or chronicity of the LBP complaint and spinal stiffness. There was little agreement between the stiff or tender segments identified by the clinicians using palpation and the segment that measured most stiff using the PAS device.

Process development for ethical recruitment of patients into simultaneous clinical studies in a chiropractic research clinic.

OBJECTIVE: To develop a process at one institution that creates an ethical means to bring other research projects to the attention of an individual who was excluded from the project for which they originally expressed interest, and to discuss the ethical issues surrounding patient recruitment and enrollment. METHOD: General consensus process via meetings of investigators involved in the ongoing trials at one institution. RESULTS: A process and flow sheet for offering new study information to individuals who did not meet the criteria for participation was developed. Once rejected, an individual can be asked if they wish to learn about other studies, are sent home with information, and are instructed to call back if they wish to volunteer. Consent can be used to take baseline information from the first study and apply it to the second. CONCLUSION: This process was developed and implemented for use in this research center.