Active clinical trials for "Back Pain"

Mobile health applications (mHealth apps) are transforming medical research and intervention by allowing constant, instantaneous and personalized access to patients. The investigators have designed a mHealth app (Stanford SpineKeeper) utilizing the Apple ResearchKit and HealthKit platform, which is an open source software framework designed Apple Inc to be used by medical researchers to use for research purposes. The investigators will assess whether a multidisciplinary intervention delivered through the application can help improve quality of life and minimize symptoms in patients with chronic low back pain.

The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA (Dysport - Ipsen Pharmaceuticals) in chronic low back pain. The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A into erector spinae muscles (extensors of the spine) can relieve low back pain through anti-spasm and analgesic effect of botulinum toxin.

Low back pain is a common condition, affecting majority of the adults in the United States at some point in their lives. Fortunately, most resolve, even without treatment. However, some suffer from continued or recurrent pain. For those suffering from continued or recurrent low back pain, numerous treatment options exist. One such option is an epidural injection, particularly when other non-surgical treatment options have failed. An epidural injection is the placement of a needle into the space around the spinal cord with the aid of a live X-Ray machine, followed by an injection of various medications. Typically, the medication that is injected is a steroid, commonly with the combination of local anesthetic medication. Epidural steroid injections, with or without local anesthetic is part of the established standard of care in the United States for those with continued or recurrent low back pain. The steroid is believed to reduce inflammation and edema of the injured or irritated nerves. However, despite the routine use of epidural steroids, the steroid itself is not without risks or side effects. Though rare, the steroids have been associated with complications including osteoporosis, steroid induced myopathy, cataracts and many others. In order to minimize the side effects associated with epidural steroids, limiting the dose and frequency have been outlined. Clonidine is another medication, commonly used in numerous clinical settings. U. S. Food and Drug Administration approved the medication for epidural use for cancer pain but studies have shown effectiveness in non-cancer pain was well and is routinely used for various conditions. There is growing evidence on the use of epidural clonidine for treatment of pain, including low back pain. This research will study and compare the effectiveness, if any, of clonidine compared to steroid in an epidural injection for low back pain.

To assess changes in pain and function in patients with discogenic low back pain after a standard of care intradiscal injection of Platelet-Rich Plasma (PRP).

The purpose of the research is to collect and examine spinal disc and ligament tissues to see if there are any biological markers that can be correlated with MRI images to help us learn more about causes of back pain. Spinal discs are the pillow-like cushions between the bones of the spine. They act as shock-absorbers for the spine. Spinal ligaments support the disc structure during movement.

Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is mainly based on MR imaging, showing MODIC I or II changes in patients with concordant symptomatology. The treatment of discogenic low back pain is nevertheless difficult: intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with notable risk of side-effects. In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in patients with disabling discogenic pain is assessed.

The purpose of this study is: - To validate or not the interest of the classification using the pragmatic application of clinical predictive rule for low back pain to identify patients with good prognosis following a brief spinal manipulation intervention. Patients (n = 100 to 150) : Recruited from emergency department of Saint-Luc hospital by medical doctors Inclusion criteria: A. Non-specific (No red flags) acute low back with mobility deficit (limitation in bending) and a pain duration < 16 days and no symptoms distal to the knees, male and female patients aged 19-55 years. Exclusion criteria: Specific LBP (red flags) and radiating beyond the knee Low Back Pain Non-specific subacute and chronic Recurrent low back pain (more than 3 painful episodes) Lumbar instability or hyper laxity (instability catch, active straight leg raise (SLR) > 90°, aberrant movement,range of motion (ROM) of le lower lumbar spine > 50° during standing flexion), pregnancy and post-partum status High irritability = necessity of opioid medication or intravenous injection of medication in the emergency department previous history of surgical intervention in the low back area Intervention: - 3 sessions within one week of spinal manipulation (thrusts, grade V) comparison: - 3 sessions of false/sham manipulation (placebo) in side lying on thoraco-lumbar hinge in a grade II Co-intervention similar in both group: = traditional medical care (TMC) - Reassure patients, avoid bed rest, advise them to stay active and to take analgesics (if needed such as paracetamol) (European Guidelines for non-specific acute low back pain ; van Tulder et al. 2006 ; Koes et al. 2010). Outcomes: Use of effect sizes by standardized mean of difference. ANOVA one and Two Way, number needed to treat (NNT) analysis and intention to treat analysis on all outcome variables: Primary: Kinematic Variables: two indices, logit score for the amplitude and velocity (Hidalgo et al., 2012) and patient's expectation from manual therapy (MT) treatment to improve his LBP Secondary: Pain in the presentation with visual analogical scale (VAS) and the repartition (body diagram), Oswestry Disability Index (ODI, questionnaire on pain and function), patient specific function (PSF), fear avoidance beliefs questionnaire (FABQ), Start back tool, physical examination, medication use, return to work and treatment side effects, patient's belief in a real MT intervention or not (at the end of the follow-up) Study design: Double blind ie: patients and assessors blind. The methodological quality of the study is the 8-9/10 on the PEDro scale, we will strictly follow the CONSORT statement and will be register in clinical.trials gov Evaluators: Christine Detrembleur (PT-PhD-UCL), Maxime Gilliaux (PT-PhD-student-UCL) Responsible for the study: Henri Nielens (MD-PhD-UCL) Practitioner and investigator: Benjamin Hidalgo PE, PT-MT, DO, PhD-student Certificate in Orthopedic Manual Therapy (Manual Concepts, Curtin University) Assistant-Professor Faculty of Physical therapy (FSM-UCL) Belgium International collaborator: Timothy Flynn (PT-PhD), Regis University, Denver, USA

Low back pain is a usual conditions in the western countries and several treatments available for patients with "non-specific low back pain". According to the European guidelines are exercise and cognitive intervention effective on pain and function(www.backpaineurope.org), but it have no documented effect on return to work. In addition, there is no documentation that treatments which focus on a single treatment, is effective with regard to return to work for sick-listed patients. The challenges for health personnel is not cure of the patients back pain, but to build up rehabilitation programs which focus on disability and work incapacity, in patients which are at risk of loosing their work. Dr. P. Loisel, Montreal, Canada", has since 1995 treated patients with back pain according to the "The PREVICAP model - (PREVention of work handICAP)", where the main purpose with work-related program is to prevent prolonged disability and to help patients back to work. Loisel demonstrated that the PREVICAP models accelerated the "return to work" factor by a factor 2.4 (p=0.01). The PREVICAP model have also been evaluated in Amsterdam, by Dr. Anema with the same results. At the Back Clinic, Ullevål University Hospital we have evaluated several exercise programs with good effect on pain and function, but not on the return to work rate. We are planning to do a randomized controlled trial after the PREVICAP model. All included patients in both groups, will have an clinical examination by specialist in Physical Medicine and Rehabilitation and an exercise program. Patients will be randomized to a work-related rehabilitations program or to usual care by the general practitioner. Hypothesis Main hypothesis: Sick-listed patients with back pain, who will be randomized to the work-related rehabilitation programs, will return to work faster than patients randomized to usual care by the general practitioner. Second hypothesis: A cost-benefit analysis will favor the exercise program and work place intervention

The purpose of this study is to compare the clinical outcomes and costs associated with two different management strategies for patients with acute low back pain who consult their primary care physician. The investigators hypothesize that management using a brief, standardized physical therapy intervention will result in better outcomes than management based on current practice guideline recommendations of watchful waiting for the first 4 weeks following consultation.

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.