U.S. Spine & Sport Foundation is proud to announce that it was recently awarded a research grant to conduct a clinical trial titled, “Continuous Low-Level Heat Wrap Therapy Alone and Combined with Active Exercise for Acute Low Back Pain: Effect of Functional Ability”. Details of the study are provided below.

Investigators: John M. Mayer, Ph.D. (Principal Investigator) and Vert Mooney, M.D.

Background Information: Low back pain is one of the leading causes of disability and the scope of the problem continues to grow. Moreover, debilitating low back pain affects 60-80% of adults at some point in their lives. Without proper treatment many low back pain sufferers are left with trunk muscle dysfunction, which may lead to future incidences of back pain. Patient-active therapies (e.g., physical exercise) and passive modalities (e.g., heat and ice) are frequently used to treat low back pain and have been recommended by the United States Department of Health and Human Services.

Recently, a disposable and light-weight heat wrap has been developed to administer topical heat to the low back. The heat wrap is made of a cloth-like material and is easily self-applied, conforming to the body's low back region. The wrap warms to 104o F (40o C) within 30 minutes and delivers at least eight hours of controlled heat. The wrap has been cleared for marketing by the U.S. Food and Drug Administration and is safe for human use. Published research has shown that the wrap effectively relieves low back pain and muscle soreness. It is unknown, however, if the wrap improves the ability to perform work tasks and activities of daily living, or if combining it with exercise results in additional benefits.

Purpose: The purpose of this study is to compare the effects of heat wrap therapy and exercise on functional ability, disability, pain relief, and patient satisfaction in patients with acute (i.e., less than three months duration) low back pain.

Participants & Interventions: Ninety-six individuals with low back pain between the ages of 18-55 years will be asked to participate in a randomized clinical trial. The participants will be assigned to one of four groups that will receive either heat wrap alone, heat wrap combined with exercise, exercise alone, or an educational booklet. Participants will complete four visits over one week at physical therapy centers in San Diego County. Study-related procedures are provided at no charge and participants will be compensated up to $40. The study runs from August 2003 through February 2004.

Printable Study Brochure