Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial (original) (raw)

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

BMC Complementary and Alternative Medicine, 2014

Background: Low 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.

Lumbar motion changes in chronic low back pain patients

The Spine Journal, 2014

BACKGROUND CONTEXT: Several therapies have been used in the treatment of chronic low back pain (LBP), including various exercise strategies and spinal manipulative therapy (SMT). A common belief is that spinal motion changes in particular ways in direct response to specific interventions, such as exercise or spinal manipulation. PURPOSE: The purpose of this study was to assess changes in lumbar region motion for more than 12 weeks by evaluating four motion parameters in the sagittal plane and two in the horizontal plane in LBP patients treated with either exercise therapy or spinal manipulation. STUDY DESIGN/SETTING: Secondary analysis of a subset of participants from a randomized clinical trial. PATIENT SAMPLE: One hundred ninety-nine study participants with LBP of more than 6 weeks' duration who had spinal motion measures obtained before and after the period of intervention. OUTCOME MEASURES: Lumbar region spinal kinematics sampled using a six-degree-offreedom instrumented spatial linkage system. METHODS: Trained therapists collected regional lumbar spinal motion data at baseline and 12 weeks of follow-up. The lumbar region spinal motion data were analyzed as a total cohort and relative to treatment modality (high dose, supervised low-tech trunk exercise, SMT, and a short course of home exercise and self-care advice). The study was supported by grants from Health Resources and Services Administration, Danish Agency for Science Technology and Innovation, Danish Chiropractors Research Foundation, and the University of Southern Denmark. No conflicts of interest reported. RESULTS: For the cohort as a whole, lumbar region motion parameters were altered over the 12week period, except for the jerk index parameter. The group receiving spinal manipulation changed significantly in all, and the exercise groups in half, the motion parameters included in the analysis. The spinal manipulation group changed to a smoother motion pattern (reduced jerk index), whereas the exercise groups did not. FDA device/drug status: Not applicable.

Effects of low back pain stabilization or movement system impairment treatments on voluntary postural adjustments: a randomized controlled trial

The Spine Journal, 2014

BACKGROUND: People with low back pain (LBP) exhibit impaired anticipatory postural adjustments (APAs). OBJECTIVE: To evaluate whether current motor retraining treatments address LBP-associated changes in movement coordination during tasks that do and do not require APAs. DESIGN: Prospectively registered randomized controlled trial with a blinded assessor. SETTING: Outcome evaluations occurred in a university laboratory; treatments were carried out in outpatient physical therapy clinics. PATIENTS: Fifteen subjects without LBP and 33 subjects with chronic, recurrent, and nonspecific LBP. INTERVENTION: Twelve subjects with LBP received stabilization treatment, 21 received movement system impairment-based treatment, for more than 6 weekly 1-hour sessions plus home exercises. MEASUREMENTS: Pre-and post-treatment, surface electromyography (EMG) was recorded bilaterally from trunk and leg muscles during unsupported and supported leg-lifting tasks, which did and did not require an APA, respectively. Vertical reaction forces under the contralateral leg were recorded to characterize the APA. Oswestry disability scores and numeric pain ratings were also recorded. RESULTS: Persons with LBP demonstrated an impaired APA compared with persons without LBP, characterized by increased premovement contralateral force application and increased postmovement trunk EMG amplitude, regardless of the task. After treatments, both groups similarly improved in disability and function; however, APA characteristics did not change (ie, force application or EMG amplitude) in either task. LIMITATIONS: Treating clinicians were not blinded to treatment allocation, only short-term outcomes were assessed, and main effects of treatment do not rule out nonspecific effects of time or repeated exposure.

Immediate effects of a lumbar spine manipulation on pain sensitivity and postural control in individuals with nonspecific low back pain: a randomized controlled trial

Chiropractic & Manual Therapies

Background According to the American Physical Therapy Association, there is strong evidence to show that vertebral mobilization and manipulation procedures can be used to improve spinal and hip mobility and reduce pain and incapacity in low back pain patients that fit the clinical prediction rule. Objectives: To evaluate the immediate effects of high-velocity low-amplitude (HVLA) manipulation on pain and postural control parameters in individuals with nonspecific low back pain. Methods This study used a participant-blinded and assessor-blinded randomized controlled clinical trial involving a single session, in which 24 participants were randomly distributed into control (simulated manipulation) and intervention (HVLA lumbar manipulation) groups. The primary (pain: subjective pain intensity and pressure pain threshold) and secondary outcomes (postural control: ellipse area, center of pressure [COP] excursion, COP RMS velocity, and differences between the COP and center of projected g...

Do participants with low back pain who respond to spinal manipulative therapy differ biomechanically from non-responders, untreated or asymptomatic controls?

Study Design: Non-randomized controlled study Objective: To determine if low back pain (LBP) patients who respond to spinal manipulative therapy (SMT) differ biomechanically from non-responders and untreated asymptomatic controls. Summary of Background Data: Some, but not all LBP patients report improvement in function after SMT. When compared to non-responders, studies suggest that SMT-responders demonstrate significant changes in spinal stiffness, muscle contraction and disc diffusion. Unfortunately, the significance of these observations remains uncertain given methodological differences between studies including a lack of controls. Methods LBP participants and asymptomatic controls attended three sessions over 7 days. On sessions 1 and 2, LBP participants received SMT (+LBP/+SMT, n = 32) while asymptomatic controls did not (-LBP/-SMT, n = 57). In these sessions, spinal stiffness and multifidus thickness ratios were obtained before and after SMT and on day 7. Apparent diffusion coefficients (ADC) from lumbar discs were obtained from +LBP/+SMT participants before and after SMT on session 1 and from a LBP control group that did not receive SMT (+LBP/-SMT, n = 16). +LBP/+SMT participants were dichotomized as responders/non-responders based on self-reported disability on day 7. A repeated measures ANCOVA was used to compare ADCs among responders, nonresponders and +LBP/SMT, as well as spinal stiffness or multifidus thickness ratio among responders, non-responders and –LBP/-SMT subjects. Results: After the first SMT, SMT-responders displayed statistically significant decreases in spinal stiffness and increases in multifidus thickness ratio sustained over 7 days; these findings were not observed in other groups. Similarly, only SMT-responders displayed significant post-SMT improvement in ADC. Conclusions Those reporting post-SMT improvement in disability demonstrated simultaneous changes between self-reported and objective measures of spinal function. This coherence did not exist for asymptomatic controls or no-treatment controls. These data imply that SMT impacts biomechanical characteristics within SMT-responders not present in all LBP patients. This work provides a foundation to investigate the heterogeneous nature of LBP, mechanisms underlying differential therapeutic response and the biomechanical and imaging characteristics defining responders at baseline.

Clinical and psychological correlates of lumbar motion abnormalities in low back disorders

The Spine Journal, 2001

Low back pain (LBP) and low back disorders (LBDs) identify a complex constellation of conditions that frustrate both diagnosis and therapy. Dynamic quantitative assessment and questionnaire instruments directed toward psychosocial and situational variables provide potentially powerful tools for determining functional pathology and potentially outcome. Our goal was to independently assess clinical correlates of a trunk motion measurement device, the lumbar motion monitor (LMM). The reliability of the LMM as a clinical test was assessed by comparison with an independent medical examination and biobehavioral questionnaires. There were three study components. A multispecialty physician panel that administered a structured physical examination contributed to a clinical correlation case series study. Standardized outcomes and risk identification questionnaires were administered to the case population. Finally, the LMM was administered in a customary fashion to the same population. Nineteen subjects were recruited on the basis of criteria that included symptoms of chronic recurrent low back pain. This was an employed and active, although impaired, population. Eighteen of the subjects were currently employed with limited lost work time, but chronic and recurrent pain was a common feature. Questionnaire outcome measures were both characterologic and situation based. In addition to providing diagnoses, the physician panel was also asked to offer certain qualitative assessments, such as rehabilitative potential and functional level pertinent to activities of daily living. The impact of LMM measures on physician decision making was also assessed. Trunk angular measurements were used to assess function of patients with chronic low back disorders. Kinematic performance on the LMM was expressed as three probability scores. These were the likelihood of abnormality, the "sincerity of effort" (exacerbation or aggravation of impairment), and the likelihood of structural anatomic disease. These variables were examined against established self-report measures of pain and disability. The LMM and physician panels were in agreement on the presence or absence of abnormality. LMM findings tended to be more consistent with clinical history than the clinical examination. The LMM results were also generally consistent with the self-reported measures of pain and disability: a high likelihood of structural disease was associated with depression, somatization, poor health perception and diminished vitality. The LMM appears to be a useful assessment tool for gauging the presence of LBP and LBD. It was accurate in detecting abnormality when abnormality was determined by clinical history and physician diagnosis. The LMM's differentiation of mechanical low back disease (nonanatomically specific disorders) from structurally specific low back disease was not consistent with a parallel clinical differentiation. Larger trials in a prospective format and studies on a chronically disabled population seem warranted. In an impaired but less disabled population, elevated pain and somatization did not appear to weaken the effort during testing.

A randomized control trial to determine the effectiveness and physiological effects of spinal manipulation and spinal mobilization compared to each other and a sham condition in patients with chronic low back pain: Study protocol for The RELIEF Study

Contemporary clinical trials, 2018

Low back pain (LBP) is one of the most common reasons for seeking medical care. Manipulative therapies are a common treatment for LBP. Few studies have compared the effectiveness of different types of manipulative therapies. Moreover, the physiologic mechanisms underlying these treatments are not fully understood. Herein, we present the study protocol for The Researching the Effectiveness of Lumbar Interventions for Enhancing Function Study (The RELIEF Study). The RELIEF Study is a Phase II RCT with a nested mechanistic design. It is a single-blinded, sham-controlled study to test the mechanisms and effectiveness of two manual therapy techniques applied to individuals (n = 162; 18-45 years of age) with chronic LBP. The clinical outcome data from the mechanistic component will be pooled across experiments to permit an exploratory Phase II RCT investigating the effectiveness. Participants will be randomized into one of three separate experiments that constitute the mechanistic compone...