The Effect of Foot Reflexology Massage on Neuropathic Pain

Not Applicable

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT06951412
• Lead Sponsor: University of Gaziantep

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.

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-15
• Study First Submitted: 2024-06-22
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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.-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pain score	6 Weeks	visual analog scale:VAS: It is a scale scored between 0 and 10 points. A score of 0 indicates that the patient has no pain, and a score of 10 indicates that the patient has unbearable pain. The patient gives a score between 0 and 10 depending on the pain condition.

Secondary Outcome Measures

Name	Time	Method
Four Question Neuropathic Pain Questionnaire	6 weeks	This questionnaire consists of a total of 10 items; 7 items are related to the quality of pain (burning, painful cold, electric shocks) and its relationship with abnormal sensations (tingling, pins and needles, numbness, itching), and 3 items are related to the clinical examination of the painful area (touch hypoesthesia, pricking hypoesthesia, tactile allodynia). Each item is scored 1 if the answer is yes and zero if no, with a minimum of zero and a maximum of 10 points. In this assessment, a score of ≥4 out of 10 is considered neuropathic pain

Trial Locations

Locations (1)

Gaziantep University; 🇹🇷 Gaziantep, Turkey