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Reflexology in Diabetic Neuropathic Pain Management

Primary Purpose

Reflexology, Neuropathic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reflexology
Control
Sponsored by
Istanbul Saglik Bilimleri University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Reflexology focused on measuring Type 2 Diabetes, Quality of Life, Nursing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Saglik Bilimleri University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

reflexology practice

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 28, 2020
Last Updated
September 24, 2020
Sponsor
Istanbul Saglik Bilimleri University
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1. Study Identification

Unique Protocol Identification Number
NCT04564131
Brief Title
Reflexology in Diabetic Neuropathic Pain Management
Official Title
The Effect of Reflexology Massage Applied to Diabetic Neuropathic Pain on Patients Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Saglik Bilimleri University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reflexology, Neuropathic Pain
Keywords
Type 2 Diabetes, Quality of Life, Nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
reflexology practice
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Reflexology
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No intervention was performed to reduce pain in the control group
Primary Outcome Measure Information:
Title
pain intensity
Description
According to the Douleur Neuropathique 4 Questions (DN4) questionnaire, neuropathic pain score changes to less than 4 points.
Time Frame
5 Months
Title
pain intensity
Description
Change of neuropathic pain score to less than 12 points according to The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale.
Time Frame
5 Months
Title
life quality
Description
Change of quality of life score higher than 42 points according to the Neuropathic Pain Impact on Quality-of Life Questionnaire (NePIQoL) scale
Time Frame
5 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nesibe Simsekoglu, RN
Phone
+90 553 931 97 91
Email
nesibesimsek._@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Merdiye Sendir, Prof. Dr.
Phone
(216) 418 96 16
Ext
2301
Email
merdiye.sendir@sbu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesibe Simsekoglu, RN
Organizational Affiliation
Saglik Bilimleri University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saglik Bilimleri University
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30228809
Citation
Silva NCM, Chaves ECL, Carvalho EC, Carvalho LC, Iunes DH. Effect of Foot Reflexology on Capillary Blood Glucose, Tissue Temperature, and Plantar Pressure of Individuals With Diabetes Mellitus (Type 2): A Pilot Study. J Chiropr Med. 2018 Sep;17(3):182-189. doi: 10.1016/j.jcm.2018.03.003. Epub 2018 Aug 26.
Results Reference
background
PubMed Identifier
24527055
Citation
Dalal K, Maran VB, Pandey RM, Tripathi M. Determination of efficacy of reflexology in managing patients with diabetic neuropathy: a randomized controlled clinical trial. Evid Based Complement Alternat Med. 2014;2014:843036. doi: 10.1155/2014/843036. Epub 2014 Jan 9.
Results Reference
background
PubMed Identifier
22305243
Citation
Wandell PE, Carlsson AC, Gafvels C, Andersson K, Tornkvist L. Measuring possible effect on health-related quality of life by tactile massage or relaxation in patients with type 2 diabetes. Complement Ther Med. 2012 Feb-Apr;20(1-2):8-15. doi: 10.1016/j.ctim.2011.09.007. Epub 2011 Oct 22.
Results Reference
background
PubMed Identifier
28605119
Citation
Gok Metin Z, Arikan Donmez A, Izgu N, Ozdemir L, Arslan IE. Aromatherapy Massage for Neuropathic Pain and Quality of Life in Diabetic Patients. J Nurs Scholarsh. 2017 Jul;49(4):379-388. doi: 10.1111/jnu.12300. Epub 2017 Jun 12.
Results Reference
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Reflexology in Diabetic Neuropathic Pain Management

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