2. Materials and methods
This prospective study was designed as a randomized controlled, patient-blind, single-center clinical study held in Aksaray University Hospital between November 2018 and March 2019. The patients were provided detailed information about the study, and the informed consent form was signed. A total of 160 patients aged between 18 and 50 years and diagnosed with ureter stones by radiological imaging techniques (kidney–bladder–ureter radiography, ultrasonography, or computed tomography) were subsequently registered for the study. Patients who had distal ureter stones (one-third of the last part of the ureter), were pregnant, had known previous allergy to skin patches, or had difficulty comprehending the Visual Analog Scale (VAS) were excluded from the study. In addition, patients who could not withstand pain and wanted analgesic agents were excluded. Out of 160, 42 patients failed to meet the inclusion criteria, and the remaining 118 patients who fulfilled the criteria for this study were offered participation by written information, and randomization was performed to receive either heat-patch or sham treatment (Fig.1). Randomization was conducted with a closed-envelope method. On the basis of the envelope selection, for patients who chose the letter S, a heat patch (9.5 ×13.0 cm) containing iron powder, activated carbon, and water (Voltapatch; GlaxoSmithKline Pharmaceuticals) was administered to the most painful region as indicated by the patients. For those who chose the letter C, a sham-patch—a cotton pad wrapped with gauze and designed to have the same size, weight, color, and temperature (room temperature) as that of a heat patch—was applied in a similar base. The patients in both groups did not receive any medical treatment outside the patch, but analgesic treatment (3 ml of diclofenac sodium 75 mg) was initiated if the patient requested it during any period of the study. If the pain persisted, opioids (fentanyl 1.5 mcg/kg, i.v.) were the second option.
All the patients enrolled in the study were evaluated with a detailed medical history and physical examination. Patches were attached to the locations with most pain. The VAS scores were evaluated for both groups at 0, 15, 30, 45, and 60 min after patch application. All the patients were monitored, and their vital findings were checked. Their body temperature (Btemp) values were measured with a tympanic thermometer (Braun ThermoScan IRT4520; Braun GmbH, Kronberg, Germany; range 34.0–42.2°). The skin temperature (Stemp) values were measured using a thermometer (Nihon Kohden YSI-409A; Nihon Kohden, Tokyo, Japan) placed underneath the patch application site. At the end of this period, those who did not want to wait until the end and those who could not withstand pain and were given analgesic treatment (3 ml of diclofenac sodium 75 mg, i.m.) were also excluded.