Active clinical trials for "Back Pain"

This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.

Lumbar pain, or low back pain, may be defined as pain or discomfort located from the lower portion of the costal margin to the gluteal folds, with or without referred pain in the legs. This pain is classified as non-specific lumbar pain when its cause is unknown, as well as chronic when it persists for longer than three months with the appearance of disabilities for activities of daily life. Treatments for low back pain are usually pharmacological, focusing on analgesics, muscle relaxants and anti-inflammatories. Although protective factors, such as exercise, healthy diet and functional training may mitigate the evolution of pain, physical disability due to pain and functional loss reduce quality of life. Photobiomodulation (PBM) can be defined as the therapeutic use of light sources to reduce inflammation and relief pain. In this context, the objectives of this study are to develop and evaluate the effectiveness of an application protocol of an LED cluster for the treatment of chronic low back pain in a randomized, double-blind clinical trial that will be conducted in the outpatient facility of Universidade Nove de Julho (Uninove). Patients with chronic nonspecific low back pain, who signs the Informed Consent Form approved by the Uninove Institutional Review Board will be included in the study. Treatment sessions will be performed with a LED cluster three times a week for 4 weeks (totaling 12 sessions) in the lumbar region, and the outcomes will be measured with the following evaluations: VAS - Visual Analog Scale; Roland-Morris Disability Questionnaire (RMDQ); Schöber test; Modified Oswestry Disability Questionnaire and Algometry.

This study aims to test the efficacy of the ActiPatch® device by means of a randomized double blind controlled trial in a convenience sample of chronic low back pain patients at RPAH pain clinic. Outcome measures are validated psychometric measures evaluating known determinants of pain related disability, functional capacity measures, and pain scores; and a bespoke questionnaire assessing fidelity with recommended usage, and willingness to reduce analgesic or other pain related medications with the future assistance of the ActiPatch®.

The working hypothesis is that spa therapy in addition to usual care including home exercises (UCHE) will result in greater improvements in pain reduction, associated disability and quality of life for chronic low back pain patients. It follows that health resource consumption and linked costs should also be reduced. The primary objective of this study is therefore to compare the therapeutic effect of UCHE alone versus spa therapy in addition to UCHE for chronic low back pain.

The purpose of this prospective post market pilot study is to evaluate the effect of Burst Spinal Cord Stimulation(B-SCS) in the management of chronic discogenic pain in subjects who are refractory to other available treatments. Selected subjects will not be suitable candidates for lumbar spinal surgery and will meet the standard selection process for SCS as routinely utilized in the study centers. Results from this pilot study will inform current clinical practice and future comparative studies in this specific population. Eligible subjects for B-SCS will be asked to participate in this study. If they decide to participate, they will be treated with the Prodigy TM and Proclaim TM (Abbott Laboratories) SCS system and prospectively followed for 12 months following implantation.

Non-specific chronic low back pain is defined as pain that originates in the lumbar spine, is persistent, lasts more than 3 months, and is unrelated to an inflammatory, traumatic, tumour, malformation, or infectious cause. Chronic low back pain is one of the most frequent reasons for consulting a physician, and one of the most common sources of disability, particularly as a result of socio-professional withdrawl. It is a major consumer of health resources (diagnostic investigations, multiple treatments) and involves heavy expenses for the investigator's health insurance system. In view of this major public health issue, in November 2017, the Health Insurance and several specialized health organizations launched a "general public" campaign to raise awareness of low back pain. This campaign, entitled "Back pain? The right treatment is movement" was designed to encourage appropriate physical activity in patients with low back pain. Among the available therapies, multimodal programs are recommended as a first line treatment. In order to incorporate physical activity into patients' daily lives, these rehabilitation programs are based on a comprehensive multidisciplinary approach (therapeutic education, muscle strengthening, reconditioning, ergonomics, psychological, social, professional and nutritional management and cardiovascular risk factors). Although such programmes have already shown short term effectiveness, few data are available on their continued effectiveness in the medium term (1 year). This project aims to identify good and bad responders to a multimodal program in the medium term, based on common clinical parameters (Quebec City questionnaire score and spontaneous walking speed), and to identify the mechanisms underlying this response. In addition, in clinical practice, heterogeneity in maintaining the effectiveness of the program is observed but little documented. The limited data available show a heterogeneity of these programs and one of the objectives of this project will be to identify the existing barriers and levers available to improve this situation.

This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) in combination with the non-steroidal anti-inflammatory drug Celecoxib and the antispasmodic drug Eperisone (hereafter, "C-E drug therapy") is statistically significantly more effective than either rESWT or C-E drug therapy alone in the treatment of chronic non-specific low back pain.

The purpose of this research is to integrate the meditative components of integrative restoration (iRest) yoga nidra with simple and safe movement sequences derived from established yoga postures and physical therapy interventions for chronic nonspecific low back pain and to use telemedicine technology to facilitate the intervention in a diverse socioeconomic and racial/ethnic population. This project will first systematically adapt the iRest yoga intervention for the incorporation of movement using a consultative and iterative process followed by a pilot intervention to assess the acceptability and preliminary efficacy of this program for pain, back related function and to address body-mind regulation and biopsychosocial-spiritual well-being. Hypothesis: a yoga intervention emphasizing meditative movement and relaxation will be safe for remote delivery and effective for biopsychosocial-spiritual outcomes for people with chronic low back pain.

Clinical evidence about the effects of cannabis in the management of acute pain is rather scarce, mostly consisting of case report-based opinions on adverse events during or after general anesthesia after smoking cannabis, experimental pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages and routes of administration. It is difficult to draw strong conclusions from the available evidence, that may seem sometimes even contradictory, mainly due -the investigators believe- to the many sources of variability in the study designs (e.g.: heterogeneity of the study samples, underpowered, unblinding, lack of randomization, timing of the therapeutic intervention, different experimental pain models, inclusion of different kind of surgical pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that cannabis and cannabinoids may have a beneficial role in the management of acute pain, at least for a selected group of patients and through an appropriate therapeutic intervention. Cannabis oil seem to be most suitable to our investigation. The co-administration of tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic benefits with an attenuation of adverse effects. And will help treat acute radicular back pain

There is emerging evidence that Bowen Therapy may improve musculoskeletal pain. While it can be an effective treatment strategy to enhance pain modulation; studies on the clinical effect are scarce. The aim of this study is to examine the effectiveness of Bowen therapy for people with chronic LBP on measures of pain, function, pain-related self-efficacy, and health related quality of life. Parallel-group randomized controlled trial (RCT) study will be employed. Pain Catastrophizing Scale (PCS) will be adopted as a screening test upon the randomization. A cutoff of more than 30 points will be used to represents clinically relevant level of catastrophizing. 46 participants with informed consent who meet the eligibility criteria of study are recruited and randomly assigned to one of two groups i.e. Bowen Therapy group and Sham Bowen Conventional Therapy group. Permuted block randomization is applied to control the key confounding variable of catastrophizing which is significantly associated with pain and disability in chronic LBP. Sequentially numbered, opaque, sealed envelopes (SNOSE) is used to ensure the allocation sequence before the group allocation. Double blinding of participants and outcome assessor will be adopted. Measurements are collected at the baseline (Week 0), post-intervention (Week 6) and at a 4-week follow-up (Week 10). The primary outcomes are pain as measured by Percentage of Pain Intensity Difference (PID) and pain relief scale (PRS). The secondary outcomes are measuring the physical functioning, self-efficacy in pain and HRQoL using Owestry Disability Index (ODI), Pain Self-efficacy Questionnaire (PSEQ) and SF-12 (HK) respectively. Intervention is provided weekly for 6 sessions lasting 30-40 minutes per treatment session. The experimental group will receive Bowen therapy according to ISBT Bowen Therapy®. The control group will receive a usual OT therapy with the same number of treatment session, treatment time, including back care advice and functional rehab training.