Clinical trial NCT04564131: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Reflexology
Neuropathic Pain
Keywords: Type 2 Diabetes
Quality of Life
Nursing
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: pain intensity
timeFrame: 5 Months
measure: pain intensity
timeFrame: 5 Months
measure: life quality
timeFrame: 5 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri University
Study officials:
affiliation: Saglik Bilimleri University
name: Nesibe Simsekoglu, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.