Clinical trial NCT06951412: The Effect of Foot Reflexology Massage on Neuropathic Pain
Official title: The Effect of Foot Reflexology Massage Applied to Women With Type 2 Diabetes on Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Foot massage
Reflexology
Neuropatic pain
Nursing
neuropathy
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At this stage, the patients in the intervention group received a foot reflexology massage by the researcher in the podiatry room of the Endocrinology and Metabolic Diseases polyclinic in a quiet and calm environment for 6 weeks, two sessions per week, for a total of 12 sessions and 30-40 minutes (15-20 minutes for each foot). Data collection forms were filled out for the patients in the control group, but no application was made.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is conducted to measure the effect of foot reflexology massage on neuropathic pain in diabetic patients.Is reflexology foot massage applied to type 2 diabetic patients effective on neuropathic pain?

Detailed description: Controlling pain in individuals with diabetes; It is important for the individual to relax, increase the quality of life, reduce complications and shorten the duration of hospital stay. For this reason, the importance of neuropathic pain and its treatment is increasing in terms of public health. In this study, the effect of foot reflexology massage applied to women with type 2 diabetes on neuropathic pain was measured.

Eligibility criteria: Inclusion Criteria:

1. Those diagnosed with type 2 diabetes,
2. Being 18 years or older
3. Individuals who do not have any fractures in the extremities, skin diseases, past wound history, open wounds and unilateral or bilateral amputation, tendonitis in the ankle, active foot ulcer and infection.
4. Those who volunteer to participate in the study,
5. Those who do not have problems with verbal communication,
6. Those who have not been diagnosed with any psychiatric disease.
7. Those with neuropathic pain of 12 points and above according to the LANS score
8. Patients receiving duloxetine drug therapy
9. Those who are not pregnant
10. Patients without peripheral artery disease, deep vein thrombosis and gonatosis will be included in the study. -

Exclusion Criteria:

1. Those who did not agree to participate in the study
2. Those under 18 years of age
3. Individuals with no fractures in the extremities, skin diseases, past wound history, open wounds and unilateral or bilateral amputation, tendonitis in the ankle, active foot ulcers and infections.
4. Those who have problems with verbal communication
5. Those with neuropathic pain below 12 points according to the LANS score
6. Patients receiving treatment other than duloxetine drug therapy
7. Those who are pregnant
8. Those with any psychiatric disorder
9. Patients with peripheral artery disease, deep vein thrombosis and gonatosis will not be included in the study.-

Primary outcomes:
measure: pain score
timeFrame: 6 Weeks
Secondary outcomes:
measure: Four Question Neuropathic Pain Questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University
Study officials:
affiliation: Gaziantep University Faculty of Medicine
name: Ersin Akarsu
role: STUDY_DIRECTOR
References:
citation: Paju, W., Yusuf, R., Nurhidayah, J., Fauzi, A., Bata, V. A., & Agustine, U. (2022). The effect of foot massage on peripheral neuropathy in patients with diabetic mellitus: a systematic review. Malaysian Journal of Medicine and Health Sciences, 18(17), 354-362.
citation: de Fátima Megda, L., Terra, A. M. S. V., de Matos, J. B., de Melo Taveira, L., Martínez, B. B., de Cássia Pereira, R., ... & Santos, A. T. S. (2020). Immediate effect of foot reflexology in patients with diabetic neuropathy-Randomized Clinical Trial. Revista Neurociências, 28, 1-22.
citation: Ibrahim MM, Rizk SMA, The efficacy of foot reflexology on the reduction of peripheral diabetic neuropathic pain. J Nurs Health Sci. 2018; 7(5): 44-55.