The Effect of Massage on Diabetic Parameters

April 18, 2024 updated by: Elif Gencer Sendur, Abant Izzet Baysal University

The Effect of Massage on Diabetic Foot Risk, HbA1c and Physiological Parameters in People With Type 2 Diabetes

This research aims to investigate the effect of massage on diabetic foot risk, HbA1c and physiological parameters in individuals with type 2 diabetes. This randomized controlled experimental design will be carried out in Bolu Izzet Baysal State Hospital Köroğlu Unit Internal Medicine Polyclinic and Internal Medicine Service. According to power analysis, the minimum sample size was determined as 60 people, 30 of which were in the intervention group and 30 in the control group. Data collection tools include "Peripheral Neuropathy Sign and Symptom Score", "Ankle-Brachial Index (ABI)", "Glycemic Control Assessment (HbA1c)", "Physiological Parameters (blood pressure, heart rate and oxygen saturation)", "Inlow's 60-second Diabetic Food Screen". A total of 24 massage sessions will be applied to the intervention group, 2 times a week during the 12-week working period. Participants in the control group will continue their medical treatment protocols and massage will not be applied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

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
      • Bolu, Turkey
        • Bolu Provincial Health Directorate Bolu Izzet Baysal State Hospital

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

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between 30-75 years old,
  • Diagnosed with diabetes at least 6 months ago,
  • Absence of irritation, ulceration in the areas where the massage will be applied (hands, feet and legs),
  • No problem in verbal communication,
  • Being able to speak Turkish,
  • No diagnosis of psychiatric disease,
  • Absence of amputation in the upper and lower extremities,
  • Having HbA1c test results in the last 1 week,
  • Not having had Covid-19 in the last 6 months
  • No experience of massage application in the last 1 month
  • Willingness to participate in the research

Exclusion Criteria:

  • Presence of diabetic ulcer and foot wound,
  • Irritation and ulceration in the areas where the massage will be applied (hands, feet and legs),
  • Having problems in verbal communication,
  • Not being able to speak Turkish,
  • Having a diagnosis of psychiatric illness.

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: Intervention group
A total of 24 massage sessions will be applied to the intervention group, 2 times a week during the 12-week working period. Sesame oil will be used as the main oil in the massage application. Massage times are recommended as 10-15 minutes for upper extremity massage and 15-20 minutes for lower extremity massage.
Other: Massage therapy
Classical massage will be applied to the hands and feet, which is expected to take an average of 30 minutes.
No Intervention: Control group
Participants in the control group will continue their medical treatment protocols and massage will not be applied. Measurement tools and physiological measurements will be evaluated at the frequency specified in the intervention group, using the same measurement tools and the same measurement methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Means of Peripheral Neuropathy Sign and Symptom Score
Time Frame: Change from baseline Neuropathy score at 3 months

Peripheral neuropathy consists of two parts: symptom and symptom score. For the peripheral neuropathy symptom score;

  • Discomfort they feel in their feet,
  • Location of complaints,
  • The presence of complaints increases at night,
  • Time of occurrence of complaints and
  • 5 questions will be asked about how the complaints decreased. Peripheral neuropathy symptom score obtained from 5 questions was 0-2 points, "normal"; 3-4 points, "mild neuropathy"; 5-6 points, "moderate neuropathy"; A score of 7-9 will be considered "severe neuropathy".

For peripheral neuropathy finding score; It will be determined based on four parameters including 1. Vibration sense, 2. Pimpiric test, 3. Achille tendon reflex, 4. Protective sensory examination
Change from baseline Neuropathy score at 3 months
Means of Ankle-Brachial Index Score
Time Frame: Change from baseline Ankle-Brachial Index score at 3 months
It is calculated by dividing the tibialis posterior pressure by the brachial arterial pressure. The highest of the four measurements at the ankles and feet is divided by the two higher brachial measurements. The normal value is close to 1.
Change from baseline Ankle-Brachial Index score at 3 months
Means of HbA1c (%)
Time Frame: Change from baseline HbA1c score at 3 months
HbA1c values of the participants will be monitored as a glycemic control parameter. The HbA1c value will be evaluated at baseline and 3 months later, as it represents the three-month average blood glucose value. For the measurement of HbA1c, the test results within the last week will be taken from the participants at the beginning and a blood sample will be taken into ethylenediaminetetraacetic acid (EDTA) coated tubes (2 mL whole) by a nurse three months later.
Change from baseline HbA1c score at 3 months
Means of systolic blood pressure (mmHg)
Time Frame: Change from baseline systolic blood pressure at 3 months
It will be measured by the researcher with a manual measurement tool.
Change from baseline systolic blood pressure at 3 months
Means of diastolic blood pressure (mmHg)
Time Frame: Change from baseline diastolic blood pressure at 3 months
It will be measured by the researcher with a manual measurement tool.
Change from baseline diastolic blood pressure at 3 months
Means of heart rate (/minutes)
Time Frame: Change from baseline heart rate at 3 months
It will be measured by the researcher with a pulse oximeter.
Change from baseline heart rate at 3 months
Means of oxygen saturation (%)
Time Frame: Change from baseline oxygen saturation at 3 months
It will be measured by the researcher with a pulse oximeter.
Change from baseline oxygen saturation at 3 months
Means of diabetic foot risk score
Time Frame: Change from baseline diabetic foot risk score at 3 months
"Inlow's 60-second Diabetic Food Screen" form will be used in diabetes foot risk assessment. Diabetic foot examination consists of 12 parameters. Skin Assessment, Evaluation of Nail Structure, deformity, Evaluation of the Shoe, Heat Evaluation - Being Cold, Heat Evaluation - Being Hot, Range of Motion Evaluation, Sensory Evaluation, Sensory Evaluation (Assessment with questions directed to individuals), Evaluation of Pedal Pulses, Dependent Rubor Evaluation, Evaluation of Erythema (Redness). The minimum score to be taken from the foot examination form is evaluated as 0 and the maximum score as 23 points. The higher the score, the higher the risk of diabetic foot.
Change from baseline diabetic foot risk score at 3 months

Collaborators and Investigators

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

Sponsor

Abant Izzet Baysal University

Investigators

  • Principal Investigator: Elif Gençer Şendur, MSC, Abant Izzet Baysal University

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)

September 9, 2022

Primary Completion (Actual)

February 9, 2024

Study Completion (Actual)

February 9, 2024

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

December 2, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAIBU-SBF-EGS-2

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

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Massage therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe