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Reflexology in Diabetic Neuropathic Pain Management

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04564131
Enrollment
128
Registered
2020-09-25
Start date
2021-04-01
Completion date
2022-04-01
Last updated
2020-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain, Reflexology

Keywords

Type 2 Diabetes, Quality of Life, Nursing

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.

Interventions

OTHERReflexology

* 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.

OTHERControl

No intervention was performed to reduce pain in the control group

Sponsors

Istanbul Saglik Bilimleri University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
pain intensity5 MonthsAccording to the Douleur Neuropathique 4 Questions (DN4) questionnaire, neuropathic pain score changes to less than 4 points.
life quality5 MonthsChange of quality of life score higher than 42 points according to the Neuropathic Pain Impact on Quality-of Life Questionnaire (NePIQoL) scale

Countries

Turkey (Türkiye)

Contacts

Primary ContactNesibe Simsekoglu, RN
nesibesimsek._@hotmail.com+90 553 931 97 91
Backup ContactMerdiye Sendir, Prof. Dr.
merdiye.sendir@sbu.edu.tr(216) 418 96 16

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026