The Effect of Foot Reflexology Massage on Neuropathic Pain

April 22, 2025 updated by: Adile Nese, University of Gaziantep

The Effect of Foot Reflexology Massage Applied to Women With Type 2 Diabetes on Neuropathic Pain

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gaziantep, Turkey, 27000
        • Gaziantep University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The effect of reflexology massage on the average pain score
The effect of reflexology massage on neuropathy-related pain score
Other: Foot Reflexology Massage
Reflexology Massage
Other Names:
  • complementary therapy
Experimental: The Effect of Foot Reflexology Massage Applied to Women With Type 2 Diabetes on Neuropathic Pain
Other: Foot Reflexology Massage
Reflexology Massage
Other Names:
  • complementary therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 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.
6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Four Question Neuropathic Pain Questionnaire
Time Frame: 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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Gaziantep

Investigators

  • Study Director: Ersin Akarsu, Gaziantep University Faculty Of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
  • 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.
  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

June 22, 2024

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Foot Reflexology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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