Recent clinical trials in patients with ALBP show that SOMA 250 mg reduces disability

Feb 4 2010

A recent analysis of two pivotal clinical trials in patients with acute low back pain (ALBP) who were treated with SOMA® (carisoprodol) 250 mg showed significantly improved functionality and reduced disability after three days of treatment, as measured by the Roland-Morris Disability Questionnaire (RMDQ).  This analysis is being presented this week at the 26th annual meeting of the American Academy of Pain Medicine in San Antonio, TX.   In addition, a recent review of published literature indicates that SOMA 250 mg is the only skeletal muscle relaxant proven to significantly improve functionality in patients with acute low back pain as measured by the RMDQ.   SOMA 250 mg is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions.

"This outcomes data differentiates SOMA 250 mg among the diverse treatment choices for patients with acute low back pain," said Steven M. Simon, MD, RPh, Clinical Assistant Professor, University of Kansas and Kansas City, University of Medicine and Biosciences. "Almost all acute low back pain is mechanical in origin and one in five patients with this condition suffers from significant limitations in activity.  Treatment of acute low back pain with SOMA 250 mg has been shown to improve functionality, as measured by an internationally validated tool, and it may be a useful treatment option for many patients suffering from this common condition."

Low back pain can be a disabling condition that affects patients' ability to function.  Patients with acute low back pain may walk more slowly, sleep less, avoid common activities, and stay home.  

Outcomes-based healthcare is a comprehensive and increasingly popular approach to healthcare with goals of providing high quality care, controlling costs, and maximizing health care value based upon clinical quality and outcomes data.  This approach is increasingly influencing decisions on selection of treatment regimens, prescribing and reimbursement.  Promptly helping patients achieve clinical improvement in their functional status following acute musculoskeletal injuries is considered a key component of effective treatment and risk control strategies, and may contribute to a reduction in total healthcare costs.

"Overall, the greatest cost savings from a societal perspective may be obtained from interventions that promote early return to work and minimize lost productivity," said Al Moorad, MD, Medical Director, Integris Jim Thorpe Rehabilitation, Oklahoma City. "This may be accomplished by appropriate drug utilization to allow patients to actively participate in rehabilitation therapy and return to daily activities."

SOMA 250 mg Outcomes Data

SOMA 250 mg was studied in two multi-center, double-blind placebo-controlled clinical trials of more than 1300 subjects.  In these studies, the co-primary endpoints were met: patients receiving SOMA 250 mg reported a statistically significant improvement in global impression of change and relief from starting backache on day 3, the primary analysis, compared to placebo (P<0.0001).  

In these same studies, a secondary endpoint of patient functionality was measured.  Patients achieved significantly greater clinical improvement in functionality outcomes as measured by the Roland-Morris Disability Questionnaire (RMDQ) with SOMA 250 mg vs. placebo on day 3.  The Roland Morris Disability Questionnaire (RMDQ) is an internationally validated standard for measuring the degree of disability and functionality in patients with lower back pain. Developed in 1982 by Martin Roland and Richard Morris, the instrument is a sensitive and reliable self-evaluation tool. It is used as a marker to assess broader clinical impact of treatment modalities for patients with low back pain. Its ability to assess degree of pain at different points during treatment enables physicians to monitor patient improvement over time. The questionnaire contains 24 true/false statements regarding the effect of back pain on daily activities, adding one point per affirmative answer to the patient's total score. Its simplicity and sensitivity continue to make the RMDQ a standard assessment of back pain today.

SOMA 250 mg improved functionality as demonstrated by lower RMDQ scores compared to placebo (31% and 17% respectively).  According to published recommendations by Ostelo et. al in the journal Spine in 2008, a greater than 30 percent reduction in RMDQ score from baseline represents a clinically meaningful improvement.  Patients treated with SOMA 250 mg reported this level of improvement after 3 days of treatment.