Clinical trial NCT05920434: The Effect of Foot Reflexology and Foot Bath on Paın And Qualıty of Lıfe Applıed to Dıabetıc Neuropathıc Paın
Official title: Gaziantep University's Clinical Research Ethics Committee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy, Painful
Keywords: Diabetes
Neuropathic Pain
Foot Reflexology
Foot Bath
Lead sponsor: Adiyaman Provincial Health Directorate
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: (I) Foot reflexology group Individuals in the foot reflexology group were treated by the researcher once a week for a total of 60 minutes, 30 minutes on each foot, for 6 weeks.

(II) Foot bath group In the first meeting, each patient in the foot bath group was informed about the way of doing a footbath in practice. Each patient in the foot bath group was asked to apply a foot bath for 10 minutes, 3 times a week, and twice a day for 6 weeks. A plastic foot bath tub (42 x 37 x 12 cm) without a massage function is provided for each of the patients (Figure 2D). In order not to miss the applications, the patient was followed up by phone on the specified days (3 times a week, Monday-Wednesday-Friday). The patient was told that the foot bath water should be at 40 degrees celsius and that his feet should be kept in water for 10 minutes, approximately 10 cm above the ankle 25. The patient came to the clinic for the forms and protective sensory examination in the 2nd, 4th, and last week.

Control group Forms and protective sensory examination tests were applied to the patients in the control group, as in the intervention groups, and no application was made other than standard nursing care.

Eligibility criteria: 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,

Primary outcomes:
measure: Pain scores
timeFrame: 6 weeks
measure: Pain severity
timeFrame: 6 weeks
Secondary outcomes:
measure: Sensory level
timeFrame: 6 weeks
measure: Vibration sense
timeFrame: 6 weeks
Other outcomes:
measure: The quality of life
timeFrame: 6 weeks
Locations:
city: Adıyaman
country: Turkey
facility: Reva Gundogan
Study officials:
affiliation: Adıyaman Provincial Health Directorate, Adıyaman Provincial Ambulance Chief Physician
name: Reva Gundogan, Expert Nurse
role: STUDY_CHAIR
References:
citation: 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.