Active clinical trials for "Low Back Pain"

Abstract. Insufficient motor control mechanism of transversus abdominus and multifidus muscles is the most important cause of the chronic nonspecific low back pain (CNLBP). Recently, applications sre developed that generates audio and vibrant stimuli in response to anteroposterior and mediolateral rotations and can be adapted according to subject-specific movement sensitivity. Objective. The objective of this study was to compare effects of a biofeedback application that is alternative to physiotherapist feedback in core stabilization training of patients with chronic nonspecific low back pain. Design. This study was a parallel group randomized controlled trial with outcome assessment. Patients. The participants were 38 patients with chronic (≥12 weeks) nonspecific low back pain. Interventions. Patients were randomly assigned to receive either physiotherapist feedback or Perfect Practice (Level Belt Pro Inc.) biofeedback. Patients in both groups received 12 sessions, 30 minutes of three weekly graded functional core education trial. Measurements. Primary outcome measures were muscle strength (transversus abdominus and multifidus) pain intensity (Visual Analog Scale) and functional level (Revised Oswestry Disability Index); secondary outcomes were flexibility (modified Schober test), range of motion (universal goniometer), proprioception (Active Reposition Test), patient beliefs (Fear Avoidance Beliefs Questionnaire), psychological status (Beck Depression Index), and quality of life(36 Item Short-Form Health Survey questionnaire [SF-36]). Limitations. Outcome measures for muscle strength did not include objective assesment. Keywords. Chronic low back, core stabilization training, biofeedback, pain, function

Probiotics for spinal inflammatory end-plate changes, so-called Modic changes, a randomised controlled study Modic changes are inflammatory end-plate changes primarily affecting the lower lumbar levels. They are associated with disc degeneration, disc herniation and age, and are only seen on magnetic resonance imaging of the lumbar spine, not on X-ray. Three different types of Modic changes have been described, type 1, 2 and 3, the latter being rare [5]. It has been shown that type 1, but not type 2, is associated with more intense low back pain (LBP) and worse LBP outcome including a lower rate of return to work [7]. In addition, more inflammatory cells have been identified in this type of structural abnormality [25]. Modic changes may affect up to 20% of the general population and more than the double proportion in clinical populations, type 1 and 2 being about equally represented [6]. The investigators have estimated that at least 5,000 of the patients, who are referred to secondary health care in Denmark for LBP per year, will suffer from type 1 Modic changes. Based on a hypothesis of infection as the cause of Modic changes, a randomised clinical trial with one year follow-up has been performed [16]. This trial documented significant effect of long-term (100 days) broad-spectrum antibiotic treatment (amoxicillin/ clavulanic acid) in patients with type 1 Modic changes. However, infection in Modic changes has not been documented convincingly in this or in other studies, and almost all of the treatment effect occurred after the antibiotic treatment was stopped. As yet, the study has not been replicated. The investigators hypothesize that the treatment effect may have been caused by an effect on the gut microbiom possibly explaining the delay of the effect. Probiotics have been shown to influence interleukins in patients with inflammatory conditions and in healthy volunteers [32, 36, 37]. The investigators are therefore performing a randomised trial to study the clinical effect of probiotics on type 1 Modic changes as well as the effect on interleukin levels. The trial is designed as a randomised, clinical, double blind, placebo-controlled trial taking place at the Spine Center, Silkeborg Regional Hospital. Power calculation was based on a smaller treatment effect than the effect found in the study above and resulted in the requirement of including 94 patients. One-year follow-up is planned. The investigators use lactobacillus rhamnosus GG (Dicoflor®) for the trial, as this strain has been used in several clinical studies. The dietary supplement has been shown to influence relevant interleukins significantly, and it has been proven to be stable in action and safe, also in pregnancy. A positive result of such a trial may have significant consequences. The perspective of using probiotics instead of antibiotics in this common disorder is very attractive. At the time being, many type 1 Modic patients in Denmark and other western countries are treated with antibiotics. This is of great concern because of side effects and possible drug resistance development of bacteria. The Technology Transfer Office of Aarhus University is involved.

The relevance of this study is given by the feasibility to assess the effect of an intervention program based on the postural control and trunk neuromuscular activity, comparing two methods: stabilization exercises vs. back strengthening exercises, in athletes with low back pain. The main outcomes will be computed by electromyography measurement so that to assess the trunk neuromuscular activation pattern as well as by force platform parameters for determining of postural control. Clinical symptoms such as pain intensity, perception of disability and fear and avoidance will also be computed. This is the first study to compare two intervention methods using the main biological outcomes related to trunk neuromuscular function.

The purposes of this study include 1) determine clinical utility of clinical observation of aberrant movement patterns during functional trunk and pelvic movements in asymptomatic individuals and patients with non-specific low back pain, 2) characterize trunk neuromuscular control in asymptomatic individuals and patients with non-specific low back pain, and 3) determine the appropriate physical therapy intervention that addresses trunk neuromuscular control deficits in patients with non-specific low back pain.

This is a 1-year trial designed to gather information about the use of the Quell for persons with chronic musculoskeletal low back pain.

The purpose of this study is to evaluate the efficacy and safety NVP-1203 in patients with Acute low back pain

The main goal of this study is to get to know if applying both, massotherapy plus hypopressive abdominal gymnastics (H.A.G) will reduce the pain of chronic non-specific low back pain. It actually reduces the inability produced by the pain and improve the patient's quality of life as well as the join range of the lumbar spine, way more than these two therapies applied separately.

The purpose of this study is to determine the short-term effects of thoracic spine thrust manipulation on participants with low back pain. Participants in this study will be randomized to receive either the lower thoracic spinal manipulation and a standard set of exercises, or a sham manipulation and the same standard set of exercises. It is hypothesized that thoracic manipulation when combined with core strengthening exercises will have positive short term improvements in pain and function for patients with LBP as compared to a sham manipulation combined with core strengthening exercises.

This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.

Up to 80% of Australians experience back pain and 10% have significant disability as a result. There is a critical need for the development and evaluation of innovative treatments that have the capacity to target the multidimensional nature of chronic low back pain. This study will compare the effects and mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for chronic low back pain. Results will ultimately lead to streamlined interventions designed to efficiently maximise benefit.