Diabetic Neuropathy, Painful Clinical Trial
Official title:
Gaziantep University's Clinical Research Ethics Committee
Verified date | June 2023 |
Source | Adiyaman Provincial Health Directorate |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction: Pain relief in diabetic neuropathy is one of the main goals of treatment. Foot reflexology and foot bath, which are two of the important applications of holistic approaches, reduce pain and can significantly increase the quality of life. Objective: In the current study, it was aimed to examine the effects of foot reflexology and foot bath applied to diabetic individuals with neuropathic pain on pain and quality of life. Method: In this randomized controlled study, the sample was randomized into three groups: (I) Foot reflexology (n: 30), (II) Foot bath (n: 30), and (III) Control (n: 30). The "Patient Information Form", "DN4 Pain Questionnaire", "Neuropathic Pain Impact on Quality-of-Life questionnaire (NePIQoL)", and "Visual Analog Scale (VAS)" were used to collect research data. In the study, a protective sensory examination was also performed with the Semmes-Weinstein Monofilament (SWM) Test and the Vibration Test (128 Hz diapason). Apart from these, foot care training was given to all patients included in the practice groups as the role of the diabetes nurse, based on the diabetic foot care training prepared by the Turkish Diabetes Association.
Status | Completed |
Enrollment | 90 |
Est. completion date | March 22, 2021 |
Est. primary completion date | August 21, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants diagnosed with diabetes and the value of HgbA1c = 6.5, - Participants with the DN4 = 4, - Participants with the VAS = 4. Exclusion Criteria: - Participants who were pregnant - Participants who received any other complementary therapy during the period of the study, - Participants who had history of systolic blood pressure lower than 100 mmHg in the past, - Participants who were taking systemic corticosteroids in the previous month, - Participants who with peripheral artery disease, gonarthrosis, spinal disc herniation, ankle tendonitis, active foot ulcer, and infection - Participants who had histories of Kidney, heart and brain diseases, rheumatic diseases, thyroid diseases, other hormonal disorders, and malignancy, |
Country | Name | City | State |
---|---|---|---|
Turkey | Reva Gundogan | Adiyaman |
Lead Sponsor | Collaborator |
---|---|
Adiyaman Provincial Health Directorate |
Turkey,
Zakin E, Abrams R, Simpson DM. Diabetic Neuropathy. Semin Neurol. 2019 Oct;39(5):560-569. doi: 10.1055/s-0039-1688978. Epub 2019 Oct 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The quality of life | Neuropathic Pain Impact on Quality-of-Life Questionnaire (NePIQoL)-The scale consists of 42 items in total and the item answer options are in the form of a 5-point Likert scale.Except for items 12, 15, 33, 34, which are reverse scored, all items are scored from 5-1; 5 is 'strongly agree' or 'always' and 1 is 'strongly disagree' or 'no, never'. The total score range varies between 42 and 210 .A high score on the scale indicates a low quality of life. | 6 weeks | |
Primary | Pain scores | Douleur Neuropathique 4 Questions -It consists of 10 questions in total. The total scale score is calculated by giving 1 point for the yes answer given by the patient to each of the questions and examination findings, and 0 points for the no answer. The lowest score is 0, the highest 10 points can be obtained. is evaluated. | 6 weeks | |
Primary | Pain severity | Visual Analog Scale (VAS)-It is an equidistant scale on a 10 cm horizontal plane, on one side of which there is no pain and on the other side the pain is "unbearable". The patient is asked to mark the point on this line that best expresses the severity of his or her pain. This distance, measured in millimeters, is interpreted as a "score" .For pain severity, 0 points are "no pain" and 10 points are "worst unbearable pain". evaluated as. | 6 weeks | |
Secondary | Sensory level | Semmes-Weinstein Monofilament (SWM) Test-During the test, the monofilament designed to apply 10 grams of pressure to the patients is touched to the designated areas of the foot until it forms the letter C. Pressure is applied to three different areas (1st metatarsal head, plantar surface of distal hallux, 5th metatarsal plantar surface) on both feet for one second, sufficient to bend the monofilament, and patients are asked whether they feel this pressure. Expression of pressure by the patient in at least two of the three areas on the plantar surface of the foot indicates sensory loss. | 6 weeks | |
Secondary | Vibration sense | Vibration Test (128 Hz) diapason-It is applied to the patients in the supine position with 128 Hz Diaposan.The tuning fork is placed perpendicularly and steadily on the dorsal surface of the distal phalanx of the first toe of the foot .The felt vibration time is recorded and if the patient feels the tuning fork vibration after 10 seconds, it is considered as no vibration sense. | 6 weeks |
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