View clinical trials related to Back Pain.
Filter by:The broad, long-term objective of this research protocol is to improve the quality of life for patients suffering from lumbar spinal stenosis. This objective will be met by examining the safety and clinical efficacy of epidural steroid injections for treatment of pain associated with lumbar spinal stenosis. This prospective, randomized, double-blind controlled trial (RCT) will test the hypothesis that the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone in older adults with lumbar spinal stenosis.
The CAre Management for the Effective use of Opioids (CAMEO) trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for chronic lower back pain. The study aims are to compare the interventions' (PHARM vs. BEH) effects on pain intensity, pain interference, function, and other pain relevant outcomes over 12 months.
Chronic pain affects an estimated 50 to 65 million individuals in the US, and its incidence and prevalence is steadily on the rise in correspondence with the increasing longevity of the population. Spinal pain, encompassing lower back, thoracic and neck pain, is a very common type of chronic pain that can greatly reduce quality of life. Facet joint pain is most often associated with facet arthropathy or degenerative arthritis of the joint. This condition develops due to progressive wear and tear caused by the small but repetitive strain of the joints throughout a lifetime. Strain and inflammation can induce fluid distention of the joints which in turn can result in compression of the nerve roots of the joint - the origin of the chronic pain. Current treatments for facet arthropathy and pain include oral medications, intra-articular injections of anesthetic or steroid medications, energy ablation (e.g. radiofrequency ablation) for denervation, and in some severe cases facet rhizotomy (surgical severing of the nerves). The ExAblate magnetic resonance guided focused ultrasound system enables noninvasive focal ablation of tissue. Results from feasibility studies, including those from the FDA approved feasibility study (IDE # G050177) have shown the palliative effect of the ExAblate for patients with bone metastases. It is reasonable to assume that this palliative effect of MRgFUS could also translate to the alleviation of facet pain if focused ultrasound beams are directed to the facet joints. The highly-target focal ablation could also diminish the risk of complications that are often associated with other less selective denervation techniques. The objective of this trial is to evaluate the safety and effectiveness of the ExAblate system and the treatment of pain resulting from facet joint osteoarthritis.
Low back pain is a public health problem affecting between 70-85% of adults at some time in their life. This study is being done to study the safety and effectiveness of the drug Milnacipran in treating chronic low back pain.
Rehabilitative Ultrasound Imaging (US) is a procedure used to evaluate skeletal muscle size and function to inform clinical practice. US has been shown to be a reliable and valid tool for measuring changes in trunk muscle (i.e. abdominal and back muscle) size and activity during sub-maximal contractions in younger populations. Younger adults with low back pain as compared with healthy adults without pain demonstrate smaller back muscle size, lower back muscle activity, and greater back muscle asymmetry (differences in right side compared with left side). No trials are published evaluating muscle adaptations using US in response to clinical treatments for low back pain in the older adult population. Increased muscle size and improved muscle symmetry have been reported in younger adults with low back pain who participate in low back stabilization exercises. These exercises use voluntary contractions of the back muscles with prolonged hold times and low loads. Neuromuscular Electrical Stimulation (NMES) is a treatment modality that increases muscle activity when voluntary activity is impaired and increases muscle size. Most studies assessing muscle size and activity in response to NMES have been conducted in the knee muscles (i.e. the quadriceps), while the impact of NMES on the back muscles remains relatively unexplored. Given the potential to evaluate back muscle size and activity with US, this assessment tool may be used to document muscle adaptations to a clinical intervention in older adults with low back pain. The purpose of this study is to conduct a 6-week clinical trial to determine if NMES plus lumbar stabilization exercises (i.e. NMES AND Stabilization Exercises) is superior to lumbar stabilization exercises (i.e. Moist Heat AND Stabilization Exercises) for improving back muscle size, activity, and side-to-side (i.e. right side versus left side) symmetry in older adults with chronic low back pain (i.e. low back pain of greater than 3 months). Muscle size, activity, and symmetry will be assessed using US before and after the treatments to determine if the treatments positively impact muscle. Secondary clinical measures of success will include improvements in physical, psychological, and social function pre- to post-treatment.
Manual treatment offers benefit to some patients suffering from back pain but little is known about which of the many tissue layers are affected. This study will help identify which tissues may be stimulated sufficiently to be a source for the clinical effects of treatment and to prioritize future work to understand mechanisms of back pain and to improve care. Current soft-tissue ultrasound elastography techniques, under static condition, will be extended to quantify relative displacement and strains(active and passive)across the depth of tissue strata that arise from small amplitude motions during continuous passive motion clinical procedures and in weight bearing postures. Relative movement of the stratified layers of the back, from treatment and task-generated perturbations, will enable the elastography interrogation of the tissue.
Low back pain (LBP) is considered one of the most common musculoskeletal disorders in modern society, resulting in substantial costs to society. Factors associated with the development of low back pain include poor posture, strenuous work with the body, inadequate non ergonomic work and traumas. Rotation movement pattern of the lumbar spine in different positions is essential aspect in understanding the LBP Pathophysiology. Rotation coupled with forward bending (flexion) is a dominant factor which could increase the risk LBP and disc prolapse. There is also a decline in range of motion (ROM) of rotation in forward bending (flexion) compared to neutral position during sitting and standing. In addition,lumbar rotation movement patterns differ in population with LBP compared to asymptomatic individuals. Healthy individuals exhibit rotation accompanied by consistent coupled movement patterns of lateral bending in the opposite direction at thr upper levels, and by lateral bending in tge same direction at the lower levels . while Chronic LBP patients exhibit non consistent patterns altered from those of the normal population.
There is evidence for altered muscle activity patterns in individuals with non-specific chronic back pain (NSCBP). It is unknown why these alterations in activation pattern occur and how they may be linked to pain experience and to the development of CNSBP. The main objective of this study is to investigate the spatial aspects of muscle activation in relation to fatigue/endurance and CNSBP. A novel approach, utilizing a new multi-channel surface-EMG (MCsEMG) technique will be applied in this project to get insight in fundamental mechanisms related to motor control and fatigue/endurance. In this project data from healthy persons and from patients with NSCBP will be collected and analyzed. NSCBP patients will be compared to healthy persons. To minimize heterogeneity between groups the subject's age range will be from 30 - 50 years. The investigators main hypothesis is that motor control mechanisms of the lumbar muscles are disturbed in NSCBP patients compared to normals, explaining the reduced tolerance for static postures. There has been little investigation of the lumbar musculature with MCsEMG recordings. The lumbar musculature has a complex organization; many, relatively small muscles, in a restricted area. Utilizing two HDsEMG grids with 252 Ag/AgCl contacts will be the superior non-invasive method to investigate motor control mechanisms in this region, and further the investigators understanding of neuromuscular adaptations related to NSCBP. The project may demonstrate changes that will lead us to new insight and new strategies for the treatment of back pain.
The investigators will be comparing the effectiveness of two types of chiropractic manipulation and standard medical care for patients with a recent onset of low back pain. The two types of chiropractic treatments being compared will be hands-on (manual) manipulation and mechanical-assisted (Activator) manipulation. The standard medical care will consist of a medical examination and prescription for over-the-counter anti-inflammatory medication.
INTRODUCTION Pamidronate and other bisphosphonates (bisph) have an anti-nociceptive effect in animals. In humans, IV pamidronate is analgesic in patients affected by numerous painful conditions, including cancer bone pain, complex regional pain syndrome (CRPS), ankylosing spondylitis, and rheumatoid arthritis. The investigators have explored the effect of IV pamidronate in the management of chronic low back pain (CLBP), a worldwide public health problem in terms of lost workdays, treatment costs, and suffering. The study was a randomized, double blind, dose-escalation trial of IV pamidronate. Study participants were divided among four study phases. Each group received IV placebo or escalating doses of IV pamidronate. STUDY DESIGN A phase I-II, randomized, double-blind, placebo controlled, dose finding study for the treatment of patients with CLBP with IV pamidronate. The study was first conducted at Beth Israel Medical Center, NY for the first two groups, and was completed at Mount Sinai Medical Center , NY for the remaining groups. PRIMARY OBJECTIVES The intent of this pilot study was to determine the optimal IV pamidronate treatment protocol for CLBP in a Phase III trial. Primary study aims were safety and average daily pain. Subjects used an electronic diary (LOGPAD) to record their daily adverse events (AEs) and their baseline and post-treatment average pain on the 0-10 numerical rating scale (NRS). STATISTICAL ANALYSES All the analysis were performed on an intention-to-treat basis. Primary outcomes are LOGPAD change in pain severity and whether a patient was a responder (pain score dropped ≥2 points or ≥30%). Because there was no statistical difference in these two outcomes among the 4 placebo groups, all placebo patients were combined (Comb PL) in the subsequent analyses. Primary analytic tool was mixed model for repeated measures (MMRM), assuming autoregressive covariance structure (LOGPAD pain and Brief Pain Inventory - BPI interferences), and Generalized Estimating Equation (GEE) model for categorical outcomes (Response rates and Patient Global Impression of Change - PGIC). The main objective was to assess whether the changes in outcome from baseline or the response rates were the same across the study phases, while adjusting for baseline values and time effect. Least square means were contrasted. Interaction between time and study phases were also tested to see if the treatment effect is a function of time. Fisher's exact tests or ANOVA (Kruskal-Wallis) tests were performed for cross-sectional group comparison, including baseline.