Effect of heating and cooling combination therapy on patients with chronic low back pain: study protocol for a randomized controlled trial

Background: Clinicians often apply heating or cooling stimulation for treatment of musculoskeletal pain. However, scalding, frostbite and skin ulcers may occur from the excessive use of either therapy alone. Heating and cooling combination therapy may be a suitable alternative for treatment of musculoskeletal diseases, although insufficient research has documented the safety and efficacy of such therapy. The purpose of this clinical trial is to determine the efficacy and safety of heating and cooling combination therapy for treatment of chronic low back pain. Methods/Design: This is a multicenter, parallel-group, double-blinded, randomized controlled trial to evaluate the efficacy and safety of a heating and cooling combination therapeutic device (OCH-S100) in patients with chronic low back pain. Eighty participants with chronic low back pain will be recruited from two hospitals in South Korea (Dongguk University Ilsan Oriental Hospital and Dongguk University Bundang Oriental Hospital). Enrolled patients will be randomly divided into a treatment group and a sham group. Patients in both groups will be given 10 treatments (15 min per treatment) over 4 weeks. The protocol will consist of five cycles of heating/cooling therapy (maximum: 45 degrees C, minimum: 15 degrees C) in the treatment group, and five cycles of sham therapy (maximum: 1 degrees C above skin temperature, minimum: 1 degrees C below skin temperature) in the sham group. The primary outcome measure is change from baseline in the 100 mm Visual Analogue Scale (VAS) for pain after 4 weeks. There are six secondary outcome measures that consider disability or range of motion (ROM). Discussion: This research will determine the efficacy and safety of heating and cooling combination therapy on chronic low back pain. The results of this trial may have important implications for the more widespread use of heating and cooling combination therapy for treatment of musculoskeletal pain.