Reflexology in Diabetic Neuropathic Pain Management

September 24, 2020 updated by: Nesibe Simsekoglu, Istanbul Saglik Bilimleri University

The Effect of Reflexology Massage Applied to Diabetic Neuropathic Pain on Patients Quality of Life

Reflexology massage, applied by applying pressure to any point on the feet, is one of the most popular complementary treatments in the world. Given the negative impact of neuropathic pain on quality of life and the limited effectiveness of traditional medicines, it is important to investigate the effects of various complementary therapies available, including reflexology massage. Therefore, the study was planned as a prospective randomized controlled experimental study with a pre-test and post-test design aiming to investigate the effect of reflexology massage for neuropathic pain on pain intensity and quality of life in diabetic individuals.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pressure will be applied to the relevant reflex areas of the foot based on the individual's pain area. In order to standardize the application, the procedure will start with the left foot and end with the right foot. Both feet will be massaged using petroleum jelly for 5 minutes of relaxation movements, 5 minutes of general foot massage and 5 minutes of standing and reflex area corresponding to the painful body area. 5 more minutes will be applied to the left foot in order to increase the endorphin secretion and reduce the pain by activating the parasympathetic system. Reflexology massage will be applied for a total of 35 minutes in one session. Each reflexology area will be stimulated 15 times, as less than 10 stimulation to a particular reflexology area does not produce any therapeutic effect and more than 20 stimulations will be excessive. A total of 3 follow-ups will be done throughout the study. In the follow-up sessions; Visual Analogue Scale (VAS), Douleur Neuropathique 4 (DN4), The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) , Neuropathic Pain Impact on Quality-of-Life questionnaire (NePIQoL) scales will be applied, foot assessment and SWMI test will be applied. The 1st follow-up will be done before any intervention in the 1st session, the 2nd follow-up will be done after the reflexology application in the 5th session, and the 3rd follow-up will be done after the reflexology application at the 10th session . There will be a break of at least one day between two sessions to relax the body and eliminate toxins.

Study Type

Interventional

Enrollment (Anticipated)

128

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 Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34000
        • Saglik Bilimleri 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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Those over the age of 18,
  • Literate,
  • A diagnosis of neuropathic pain associated with Type 2 diabetes,
  • Defined pain of at least 4 severity according to the Visual Analogue Scale (VAS),

Exclusion Criteria:

  • A diagnosis of disease causing neuropathy (uremia, malnutrition, liver failure, alcoholism, kidney failure, dialysis treatment, oncology patients, vitamin deficiency),
  • have a pacemaker,
  • Diabetic foot diagnosis,
  • who are pregnant,
  • Having vision, hearing, cognitive ability disorders and psychosis, Reflexology massage in the last month,
  • Receiving medical treatment with an effect that conceals neuropathic pain symptoms,
  • Disc herniation,
  • Any infectious skin disease (shingles, fungus, etc.),
  • Individuals with open lesions / wounds, scar tissue, fractures, dislocations, amputation, edema, hematoma, thrombophlebitis, inflamed and degenerative joint diseases in the lower extremities will not be included in the sample.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: reflexology practice

Blood glucose measurement with a glucometer to be provided by the researcher, blood pressure measurement with a digital blood pressure device, and foot temperature measurement with an infrared thermometer will be made. Turkey podiatry foot care guide will be trained under the guidance of the Society of Endocrinology and Metabolism.

Experimental group participants will be given 10 sessions of reflexology massage twice a week for 5 weeks. A total of three follow-ups will be performed in the 1st session, the 5th session and the 10th session. In the follow-up sessions; VAS, DN4, LANSS, NePIQol scales will be applied, foot assessment and SWMI test will be applied.
Other: Reflexology
  • Hands are washed.
  • The individual is provided to be in a comfortable position to lie down or to be in a semi-sitting position.
  • The toes of the patient are crossed and the patient's feet are placed at our chest level when we sit.
  • Depending on the size of the foot, a slightly moisturizing amount of non-allergenic petroleum jelly is taken, and it is spread to provide slipperiness.
  • Exercises to warm and relax the feet for five minutes.
  • General massage is applied to the whole foot for five minutes.
  • Reflexology massage is applied to the application areas for neuropathic pain.
  • The individual is helped to take a comfortable position.
  • Hands are washed.
EXPERIMENTAL: Control
Blood glucose measurement with a glucometer to be provided by the researcher, blood pressure measurement with a digital blood pressure device, and foot temperature measurement with an infrared thermometer will be made. Turkey podiatry foot care guide will be trained under the guidance of the Society of Endocrinology and Metabolism. 1. 3. 5. A total of three follow-ups will be done once in the week. In the follow-up sessions; VAS, DN4, LANSS, NePIQol scales will be applied, foot assessment and SWMI test will be applied.
Other: Control
No intervention was performed to reduce pain in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: 5 Months
According to the Douleur Neuropathique 4 Questions (DN4) questionnaire, neuropathic pain score changes to less than 4 points.
5 Months
pain intensity
Time Frame: 5 Months
Change of neuropathic pain score to less than 12 points according to The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale.
5 Months
life quality
Time Frame: 5 Months
Change of quality of life score higher than 42 points according to the Neuropathic Pain Impact on Quality-of Life Questionnaire (NePIQoL) scale
5 Months

Collaborators and Investigators

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

Sponsor

Istanbul Saglik Bilimleri University

Investigators

  • Principal Investigator: Nesibe Simsekoglu, RN, Saglik Bilimleri University

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

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 (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

July 1, 2021

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (ACTUAL)

September 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SY200217B06

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 Neuropathic Pain

Clinical Trials on Reflexology

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe