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.