NCT06951412

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2024

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

June 22, 2024

Last Update Submit

April 22, 2025

Conditions

Keywords

Foot massageReflexologyNeuropatic painNursingneuropathy

Outcome Measures

Primary Outcomes (1)

  • pain score

    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 Outcomes (1)

  • Four Question Neuropathic Pain Questionnaire

    6 weeks

Study Arms (2)

The effect of reflexology massage on the average pain score

EXPERIMENTAL

The effect of reflexology massage on neuropathy-related pain score

Other: Foot Reflexology Massage

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

EXPERIMENTAL

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

Other: Foot Reflexology Massage

Interventions

Reflexology Massage

Also known as: complementary therapy
The Effect of Foot Reflexology Massage Applied to Women With Type 2 Diabetes on Neuropathic PainThe effect of reflexology massage on the average pain score

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale Type 2 Diabetes patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those diagnosed with type 2 diabetes,
  • Being 18 years or older
  • 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.
  • Those who volunteer to participate in the study,
  • Those who do not have problems with verbal communication,
  • Those who have not been diagnosed with any psychiatric disease.
  • Those with neuropathic pain of 12 points and above according to the LANS score
  • Patients receiving duloxetine drug therapy
  • Those who are not pregnant
  • Patients without peripheral artery disease, deep vein thrombosis and gonatosis will be included in the study. -

You may not qualify if:

  • Those who did not agree to participate in the study
  • Those under 18 years of age
  • 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.
  • Those who have problems with verbal communication
  • Those with neuropathic pain below 12 points according to the LANS score
  • Patients receiving treatment other than duloxetine drug therapy
  • Those who are pregnant
  • Those with any psychiatric disorder
  • Patients with peripheral artery disease, deep vein thrombosis and gonatosis will not be included in the study.-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, Gaziantep, 27000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Complementary Therapies

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Ersin Akarsu

    Gaziantep University Faculty of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
experimental and control group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc prof.

Study Record Dates

First Submitted

June 22, 2024

First Posted

April 30, 2025

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 15, 2024

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations