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Acute Low Back Pain clinical trials

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NCT ID: NCT01638286 Completed - Acute Low Back Pain Clinical Trials

Study to Evaluate a Pharmacokinetic Drug Interaction Between Eperisone Hydrochloride and Aceclofenac in Healthy Male Subjects

Start date: August 2012
Phase: N/A
Study type: Observational

A randomized, open label, single-dose, 6-sequence, 3-period, crossover study to evaluate a pharmacokinetic drug interaction between eperisone hydrochloride and aceclofenac in healthy male subjects.

NCT ID: NCT01587274 Completed - Acute Low Back Pain Clinical Trials

A Randomized Study of Three Medication Regimens for Acute Low Back Pain

Start date: April 2012
Phase: Phase 4
Study type: Interventional

Low back pain causes 2.4% of visits to US emergency departments (ED) resulting in 2.7 million visits annually. In a general low back pain (LBP) population, prognosis is poor. About 50% of patients who visited general practitioners with new onset musculoskeletal LBP report persistent pain and functional disability three months after the index visit. Outcomes are similarly poor for the population of patients forced to use an ED for management of their LBP. In an observational study of patients with non-traumatic LBP recently completed at the PI's institution, patients were contacted one week after ED discharge: 70% reported persistent back-pain related functional impairment, 59% reported moderate or severe LBP, and 69% reported analgesic use within the previous 24 hours. Three months after the ED visit, 48% reported functional impairment, 42% reported moderate or severe pain, and 46% reported analgesic use within the previous 24 hours. A variety of evidence-based medications are available to treat LBP. Non-steroidal anti-inflammatory drugs (NSAID) are more efficacious than placebo with regard to pain relief, global improvement, and requirement of analgesic medication. Skeletal muscle-relaxants too are effective for short-term pain relief and global efficacy. Opioids are commonly used for moderate or severe acute LBP,(9) though high-quality evidence supporting this practice is lacking. Treatment of LBP with multiple concurrent medications is common in the ED setting. Emergency physicians often prescribe NSAIDs, skeletal muscle relaxants, and opioids in combination. Several clinical trials have compared combination therapy with NSAIDS+ skeletal muscle relaxants to monotherapy with just one of these agents. These trials have reported heterogeneous results. The combination of opioids + NSAIDS has not been evaluated experimentally in patients with acute LBP. Given the poor pain and functional outcomes that persist beyond an ED visit for musculoskeletal LBP, the investigators propose a clinical trial to evaluate whether combining muscle relaxants or opioids with NSAIDs is more effective than NSAID monotherapy for the treatment of non-traumatic, non-radicular low back pain. Specifically, the investigators will evaluate three distinct hypotheses: 1. The combination of naproxen + cyclobenzaprine will provide greater relief of LBP than naproxen alone seven days after an ED visit, as measured by the Roland Morris low back pain functional disability scale 2. The combination of naproxen + oxycodone/ acetaminophen will provide greater relief of LBP than naproxen alone seven days after an ED visit, as measured by the Roland Morris low back pain functional disability scale 3. The combination of naproxen + oxycodone/ acetaminophen will provide greater relief of LBP than naproxen + cyclobenzaprine seven days after an ED visit, as measured by the Roland Morris low back pain functional disability scale

NCT ID: NCT00952068 Completed - Acute Low Back Pain Clinical Trials

A Pharmacodynamic/Pharmacokinetic Study to Determine the Onset of Analgesic Effect and Plasma Levels of Tramadol in Patients With Acute Low Back Pain Receiving a Single 200 mg Dose of Tramadol Contramid® Once-a-Day

Start date: January 2007
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine the time of onset of analgesic effect of Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include determining the relationship between analgesic effect and plasma levels for Tramadol Contramid® OAD and to examine safety after single dose administration of 200 mg of Tramadol Contramid® OAD.

NCT ID: NCT00782925 Completed - Acute Low Back Pain Clinical Trials

An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers

PRESLO
Start date: October 2008
Phase: N/A
Study type: Interventional

At Lyon University Medical Center, back problems are the leading cause of sick leave. The course of lower back pain is usually relatively short (recovery occurs within 4 to 6 weeks in 90% of cases). However, about 5-10% develop chronic lower back pain. Although this is a relatively small group, the economic consequences are enormous (accounting for 70 to 80% of the total cost of lower back pain). Nowadays, some very general training sessions are offered to workers at Lyon University Medical Center, irrespective of their lower back pain status. These very general training sessions are mostly preventive and primary in nature (like back school program) despite the fact that these people already have a history of lower back pain, the main risk factor of recurrence and chronic pain. Since the 1980, some multidisciplinary functional restoration programs have been advised as a strategy for secondary and tertiary prevention of lower back pain. The purpose of this randomized controlled trial is to assess the effectiveness of physical exercise combined with an educational program and self-led exercise for Lyon University Medical Center workers with lower back pain. We hope this intervention will reduce the risk of recurrence and chronic lower back pain.

NCT ID: NCT00706043 Completed - Clinical trials for Chronic Low Back Pain

French Validation Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) Questionnaire

Start date: June 2008
Phase:
Study type: Observational

Low back pain is a very common disease. Among the persons suffering of acute low back pain, about 10% are at risk of developping chronic pain. A screening questionnaire assessing this risk has been developed and validated in Swedish and English (Orebro Musculoskeletal Pain Screening Questionnaire, Linton, 2003). The aim of our study is to validate a french translation of this questionnaire. Patients suffering from acute low back pain will be asked to fill in several questionnaires at day 0, and 6 and 12 month later.

NCT ID: NCT00643383 Completed - Acute Low Back Pain Clinical Trials

A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Acetaminophen and Tramadol Combination BID Versus Placebo for the Treatment of Acute Low Back Pain

Start date: March 2008
Phase: Phase 3
Study type: Interventional

A multi-center placebo controlled, double-blind, trial comparing the analgesic efficacy and safety of Acetram Contramid® BID versus placebo for the treatment of acute low back pain in patients between 18 and 80 yrs of age.

NCT ID: NCT00525811 Completed - Depression Clinical Trials

Development of a Web-Based Interactive Patient Decision Aid for the Treatment of Acute Low Back Pain and Depression

Start date: June 2007
Phase: N/A
Study type: Interventional

Shared decision making (SDM) has been advocated as an appropriate approach for physician patient communication. Positive effects of SDM are e.g higher patient satisfaction, greater treatment adherence, lower decisional conflict and better clinical outcomes. The Section of Clinical Epidemiology and Health Services Research at the University Medical Center in Freiburg (Germany) is developing and evaluating a web-based interactive decision aid ("patient dialogue") to support shared decision making in cooperation with the Techniker Krankenkasse, a large German health insurance company. Both development and evaluation are conducted along the International Patient Decision Aid Standards (IPDAS). The decision aid contains information on acute low back pain and depression and addresses insurance members who are facing a treatment decision in one of the indications. It aims at the development of patient competencies for participating in decision making, the support of constructive health behavior and patients' acceptance of evidence based treatment options. In an RCT the decision aid will be compared to a regular patient information on a sample of N=500 patients in each group. Data collection will take place at three points of time: before and after use of the decision aid as well as 3 months later.

NCT ID: NCT00343057 Completed - Acute Low Back Pain Clinical Trials

DISCO - Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP)

Start date: September 2003
Phase: N/A
Study type: Observational

To assess the impact of standardized written information on outcome in acute LBP.

NCT ID: NCT00010985 Completed - Acute Low Back Pain Clinical Trials

Usual Care Vs Choice of Alternative Rx: Low Back Pain

Start date: September 1999
Phase: Phase 3
Study type: Interventional

This study compares two approaches to the management of acute low back pain: usual care (standard benefit) vs. the choice of: usual care, chiropractic, acupuncture or massage therapy (expanded benefit). 480 subjects with uncomplicated, acute low back pain will be recruited from a health maintenance organization, and randomized to either usual care (n=160) or choice of expanded benefits (n=320). Patients' preferences for individual therapies and expectations of improvement will be measured at baseline and throughout the study. Subjects randomized to the expanded benefits arm who choose chiropractic, acupuncture or massage will receive up to 10 treatments over a five-week period. Additional treatments will be available after the fifth week but will require a copayment. Treatments will be provided by licensed providers who have met strict credentialing criteria. Chiropractic, acupuncture or massage treatments will begin within 48 hours. Chiropractic, acupuncture and massage therapy scope of practice guidelines for the treatment of acute low back pain have been developed as have detailed data tracking procedures to be used at each patient visit. Symptom relief, functional status, restricted activity days, use of health care, and patient and provider satisfaction will be assessed at 2, 5,12, 26 and 52 weeks after initiation of treatment. Primary outcomes will include: 1) change in symptoms; 2) change in functional status; 3) patient satisfaction; and 4) total utilization of services associated with care for low back pain. Medical records and the HMO's cost management information system will identify use of services. It is hypothesized that patients offered their choice of expanded benefits will experience a more rapid improvement in symptoms, a faster return to baseline functional status, a decrease in utilization of conventional medical services, and will be more satisfied with their care. The study is a direct examination of the effectiveness of an insurance eligibility intervention, not a test of the efficacy of specific, non-allopathic treatment regimens. The results of this study will provide valuable information to clinicians, patients and third party payers on the relative benefits and costs of an "expanded benefits" treatment option which incorporates chiropractic, acupuncture and massage services for low back pain.

NCT ID: NCT00000418 Completed - Acute Low Back Pain Clinical Trials

Psychosocial Treatment for Acute Low Back Pain

Start date: September 1977
Phase: Phase 2
Study type: Interventional

Acute low back pain (severe pain that comes on suddenly and lasts a relatively short time) is very common in the United States, and accounts for substantial illness, functional limitations, pain, and health care costs. This study looks at whether a program designed to improve self-efficacy (a person's belief in his or her ability to reach a goal, such as managing one's own disease) and social support improves the health status of people with acute low back pain.