Reflexology in Diabetic Neuropathic Pain Management

Not Applicable

• Conditions: Reflexology; Neuropathic Pain
• Interventions: Other: Control; Other: Reflexology

• Registration Number: NCT04564131
• Lead Sponsor: Istanbul Saglik Bilimleri University

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.

Study Timeline

• Study First Submitted: 2020-08-28
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-24
• Last Update Submitted: 2020-09-24
• Study First Posted: 2020-09-25
• Last Update Posted: 2020-09-25
• Study Start: 2021-04-01
• Primary Completion: 2021-07-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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.
reflexology practice	Reflexology	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.

Primary Outcome Measures

Name	Time	Method
life quality	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
pain intensity	5 Months	Change of neuropathic pain score to less than 12 points according to The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale.

Trial Locations

Locations (1)

Saglik Bilimleri University; 🇹🇷 Istanbul, Turkey