View clinical trials related to Low Back Pain.
Filter by:The purpose of this prospective post market observational pilot study is to evaluate the effect of DRG stimulation 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 DRG stimulation as routinely utilised in the study centre. Results from this pilot study will inform current clinical practice and future comparative studies in this specific population.
The purpose of the Stanford Center for Back Pain is to investigate and characterize the mechanisms of four treatments for chronic low back pain. These interventions (research treatment) include real-time fMRI neurofeedback, mindfulness based stress reduction, cognitive behavioral therapy, and acupuncture treatment. The investigators plan to characterize both mechanisms of treatment effects and efficacy.
Investigators will conduct a randomized controlled trial of a 30-day positive activities intervention, Positive Piggy Bank, compared to a Wait-List control group (Figure 2). Prior to their scheduled appointment to undergo epidural steroid injection, all patients meeting study criteria will be contacted by research staff to be invited to participate in this study. Those interested will be asked to arrive 45 minutes before their regularly scheduled appointment. At that time they will learn more about the study and provide informed consent if they choose to participate. Participants will then complete the study questionnaires and be randomized 1:1 to the Positive Piggy Bank condition (n=100) or the Wait List control group (n = 100). All participants will receive the usual treatment provided at the Back & Pain Center at the University of Michigan, Department of Anesthesiology (e.g., maintenance of medication regimen, standard office visits). Post-intervention (Day 30) and 2 months after that (Day 90), participants will complete the same questionnaires by mail. The primary outcome will be improved functional status, while secondary outcomes will be symptomatic (i.e., pain, fatigue and sleep) and related to mood and well-being. After the study period, the patients in the Wait List control will be offered the Positive Piggy Bank intervention and will be asked to complete one more set of questionnaires at 30 days by mail.
The aim of this study is to examine the clinical effects of supporting the human pelvis in a neutral sitting position in subjects with Low Back Pain over a 3-week period. The neutral sitting posture will be supported by a portable and adjustable "pelvic support device" or "pelvic support assembly" per US Patent number US 8,857,906 B2 that is used in the seat of the user's desk chair.
Balance problems are addressed in low back pain patients. Dearth of literature available to prove core strengthening or any form of back exercises improving functional outcomes or balance in chronic back pain patients. No studies focus on balance training in improving balance of low back pain patients. The authors are conducting a randomised trial comparing balance exercises and routine back exercise program in improving pain, functional outcomes and balance of the patients
Effect of three therapeutics strategies on the restriction of the participation of patients with a chronic back pain : multidisciplinary is it the key component ?
Low back pain (LBP) is a recognized public health problem with high life time prevalence. Medical treatment may reduce the physical and mental discomfort, while it has not been able to improve the possibilities for retaining or return patients with LBP to work. This is an occupational intervention study for patients with LBP and physically demanding work, who are at risk of drop out of labour; a randomized controlled trial designed to test the effectiveness of an early intervention for retaining subjects with LBP attached to the labour marked. A work place modification intervention combined with moderate physical activity is given in the intervention group additional to LBP treatments according to best practice recommendations for general practice. The study population consists of patients in self-reported physically demanding, who are sick listed or at risk of sick leave due to LBP. Outcome will continually be collected during the intervention as well as 6 and additionally at 12 months follow up. The primary aim is to evaluate if an occupational intervention with focus on early workplace orientated counselling and work place intervention can retain subjects with physically demanding work and LBP in gainful employment to prevent/reduce the sick leave due to LBP. The secondary aims are to identify prognostic factors of an occupational intervention using the baseline and follow-up participant-rated outcomes: pain, physically function, generic health status, fear avoidance behaviours, job satisfaction, work-ability, satisfaction with intervention, clinical examination and MRI findings. Among these variables, we also aim to identify subjects, who will benefit from such an occupational intervention, and the subjects, who already have a good prognosis and therefore have no need for a larger scale intervention.
The objective of this randomized controlled trial is to describe the effect of two osteopathic techniques - "high velocity, low amplitude" (HVLA) and muscle energy (ME) - on thickness, activation, strength, pressure pain threshold (PPT) of the paravertebral muscles at the lumbar spine, as well as the peak plantar pressures immediately and after a two-day follow-up. The muscle thickness of the paravertebral muscles at the lumbar spine, namely internal oblique, external oblique and transversus abdominis can be altered after the application of 'high-velocity low-amplitude'(HVLA)and 'muscle energy' (ME)techniques immediately and after a two-day follow-up.
RATIONALE: Exposure in vivo therapy aims to reduce pain-related fear - a key maintaining factor of chronic low back pain- while increasing level of daily functioning, despite the pain. This is done by exposing patients to their most feared activities/movements, while behavioral experiments are performed that serve to correct catastrophic (erroneous) beliefs about pain. Yet, performing exposure exercises might be very threatening for patients and might encourage them to build in subtle safety-seeking behavior. Whether safety-seeking behavior should be allowed or not during therapy is heavily debated. Whereas some argue that it will only interfere with therapeutic progress because it prevents the disconfirming experience exposure tries to offer, other argue that it will facilitate therapeutic progress because it enhances one's sense of control, if used judiciously. So far (clinical-)experimental studies have provided mixed evidence nor have they lead to any clinical recommendation. Hence, in a replicated single-case experiment, we will compare exposure therapy with versus exposure without safety-seeking behavior versus exposure only. STUDY POPULATION: Participants are chronic low back pain patients seeking treatment, who fulfill all inclusion and exclusion criteria and participate voluntarily. INTERVENTION: All participants receive exposure therapy at the rehabilitation department of the academic hospital in Maastricht, but with different recommendations for the use of safety-seeking behavior. We will assess: 1) daily measures of fear, pain intensity and self-reported achievement of goals and 2) non-daily measures of pain disability, pain-related fear, pain catastrophizing, pain solutions, need to control and safety-seeking behavior. To measure to the influence of safety-seeking behavior on actual level of functioning, two behavioral performance tasks will also be presented, ie. a bag carrying task and a personalized task. BURDEN AND RISKS: There are no risks associated with participation to this study that are not otherwise related to rehabilitation and movement in general and participation is completely voluntary. Participants are requested to fill out questionnaires on a daily basis at home (computerized if possible), as well as on different time points during the study and at follow up and perform two behavioral performance tasks. This study could help to further improve the beneficial long-term effects of exposure.
Rationale: Axial spondyloarthritis (axSpA) is an inflammatory back pain disorder affecting up to 24% of young chronic low back pain (CLBP) patients. For general practitioners (GPs) it is difficult to distinguish axSpA patients in the large amount of CLBP patients. In previous studies a referral rule for axSpA applicable in CLBP patients was developed and validated. The next step is to investigate the impact of the referral rule in daily practice. This impact analysis will test if the referral rule will be beneficial or harmful. Objective: To evaluate the clinical impact of a referral rule in young patients presenting at the general practitioners with chronic low back pain, who are at risk for axSpA, compared to usual care. Study design: A cluster randomized clinical trial. Study population: Primary care patients with chronic low back pain, aged 18-45 years. Intervention (if applicable): GPs are randomized in clusters either to use directly the referral rule or use the referral rule after 4 months. The referral rule consists out of four variables, a positive ASAS inflammatory back pain questionnaire, a positive family history for spondyloarthritis, a good reaction to NSAIDs (non-steroidal anti-inflammatory drugs) and back pain duration longer than 5 years. If at least two out of four variables are present a referral to the rheumatologist is advised. Main study parameters/endpoints: The primary outcome is a change in the Roland Morris Disability Questionnaire (RMDQ) compared to baseline in the CLBP patients with or without use of the referral model. Secondary parameters: Quality of life measurements, cost-effectiveness, pain and fatigue and referral to rheumatologist and diagnosis of axSpA. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden and risks associated with participation are minimal. No medical intervention is taken place. If the GP of the patients is randomized to the referral model, the patient is checked for the risk of axial spondyloarthritis, by the non-invasive referral model. If the referral model is positive a referral to the rheumatologist is advised. Is the GP is randomized to the 'usual care' there is no difference in the treatment of low back pain than nowadays. A GP is still allowed to treat the CLBP patients optimal and a referral to the rheumatologist is allowed but not actively advised. All participating CLBP patients are asked to fill several questionnaires at four different time points, at baseline, after 12 months and after 24 months. In total there are 8 questionnaires and four separate questions. The questionnaire are designed to fill out by the patient themselves. The total time to fill in the questionnaire is estimated to be 30 minutes. The benefits of the study are: - For the CLBP patients, up to 24% of the back pain complaints are caused by axSpA, but the GPs are not (yet) aware of this disease. When a CLBP patient is participating in this study, the chance of having axSpA as cause for the back pain is investigated. This a benefit for a CLBP patients since there is effective treatment for axSpA. - For the GP it is very difficult to distinguish an axSpA patients in the large amount of CLBP patients. If it appears that the validated referral rule has an impact on CLBP and GPs, the next step will be implementation of this referral model in daily practice and it will become a helpful tool for the GP. - For the society, CLBP is a great socioeconomic burden for the society. When one of the causes for CLBP, namely axSpA is diagnosed and treated in an earlier stage this will lead to a decreased sick leave because of back pain and is therefore potentially cost-effective.