Reflexology in Diabetic Neuropathic Pain Management

NCT ID: NCT04564131

Last Updated: 2020-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-04-01

Brief Summary

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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

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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.

Conditions

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Reflexology Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Reflexology

Intervention Type OTHER

* 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.

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.

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

No intervention was performed to reduce pain in the control group

Interventions

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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.

Intervention Type OTHER

Control

No intervention was performed to reduce pain in the control group

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Saglik Bilimleri University

OTHER

Sponsor Role lead

Responsible Party

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Nesibe Simsekoglu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nesibe Simsekoglu, RN

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri University

Locations

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Saglik Bilimleri University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Nesibe Simsekoglu, RN

Role: CONTACT

+90 553 931 97 91

Merdiye Sendir, Prof. Dr.

Role: CONTACT

(216) 418 96 16 ext. 2301

References

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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.

Reference Type BACKGROUND
PMID: 30228809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24527055 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22305243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28605119 (View on PubMed)

Other Identifiers

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SY200217B06

Identifier Type: -

Identifier Source: org_study_id

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