Reflexology in Diabetic Neuropathic Pain Management

NCT04564131 | Unknown DMC

• 1 other identifier: SY200217B06
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Reflexology; Neuropathic Pain

Keywords

Type 2 Diabetes; Quality of Life; Nursing

Outcome Measures

Primary Outcomes (3)

• pain intensity

  According to the Douleur Neuropathique 4 Questions (DN4) questionnaire, neuropathic pain score changes to less than 4 points.

  5 Months

• pain intensity

  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

  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

Study Arms (2)

reflexology practice

EXPERIMENTAL

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

Control

EXPERIMENTAL

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

Interventions

Reflexology 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.

reflexology practice

Control OTHER

No intervention was performed to reduce pain in the control group

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

Saglik Bilimleri University

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 30228809 BACKGROUND

• 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.

  PMID: 24527055 BACKGROUND

• 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.

  PMID: 22305243 BACKGROUND

• 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.

  PMID: 28605119 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Diabetes Mellitus, Type 2

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Nesibe Simsekoglu, RN

  Saglik Bilimleri University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nesibe Simsekoglu, RN

CONTACT

+90 553 931 97 91; nesibesimsek._@hotmail.com

Merdiye Sendir, Prof. Dr.

CONTACT

(216) 418 96 16; merdiye.sendir@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 25, 2020
• Study Start: April 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: April 1, 2022
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)