Diabetic Peripheral Neuropathy
Conditions
Keywords
diabetic peripheral neuropathy, hand and foot exercises, cold application, virtual reality, kinesiophobia, fraility, neuropatic pain
Brief summary
The study will be conducted to determine the effect of cold application and virtual reality (VR) or combined hand and foot exercises on pain intensity, kinesiophobia, and fragility levels in patients with diabetic peripheral neuropathy.
Detailed description
Diabetic neuropathy is associated with high morbidity and mortality rates in both Type 1 and Type 2 diabetes patients, increasing the risk of foot ulcers and amputations, hospital admission rates, and healthcare costs. It also causes a decline in individuals' quality of life, functional capacity, and physical activity levels. Especially at night, increased pain disrupts individuals' sleep patterns; psychological problems such as stress, anxiety, and depression are common. Diabetic neuropathy is a complication that affects individuals physically, psychologically, and socially. It is known that neuropathic pain accompanies the clinical picture in 25-50% of patients with diabetic neuropathy. One of the exercise programs used by healthcare professionals to alleviate symptoms in patients with peripheral neuropathy is hand and foot exercises. Studies in the literature show that hand and foot exercises performed by patients with peripheral neuropathy reduce pain levels, improve quality of life, and increase physical activity levels.Another alternative method used in the treatment of neuropathic pain is cold application. Cold application causes vasoconstriction in the blood vessels in the area where it is applied, slowing down tissue metabolism. In diabetic peripheral neuropathy, patients often describe a burning sensation in their hands and feet. Virtual reality technology has been used in the treatment and care of many diseases in the healthcare sector in recent years. VR is known to be quite effective in reducing pain, managing symptoms, and continuing care and rehabilitation outside of the hospital. VR applied to patients with diabetic peripheral neuropathy generally involves exercise interventions. The study population will consist of patients with diabetic peripheral neuropathy who visit the Diabetes Clinic of the Department of Internal Medicine at Sakarya University Education and Research Hospital. All patients who meet the inclusion criteria will be included in the study population. The G\*Power 3.1.9.2 program was used to calculate the number of individuals to be sampled. In this regard, a power level of 90% and a significance level of 0.05 were accepted in calculating the research sample. The power analysis is based on a previously published article that addressed a similar topic and provided mean and standard deviation values (Elshinnawy et al., 2024). According to the calculations, 42 patients (14 individuals in each group) are planned to be included in the study sample.The study will use a socio-demographic form, a neuropathic pain assessment questionnaire (DN4), the Tampa Kinesiophobia Scale, and the Tilburg Frailty Scale. The study will consist of two intervention groups and one control group. The Cold Application group will perform the hand and foot exercises in the exercise video three days a week, then apply cold compress bags to their hands and feet for 5-10 minutes. Patients in the virtual reality group will exercise for 15 minutes with a hand and foot exercise video in a virtual environment accompanied by cold-themed sounds and the sound of snow.Patients in the control group will be allocated time similar to the intervention flow applied to the intervention groups, and diabetic peripheral neuropathy will be explained. The explanation will cover the treatment and management of diabetic neuropathy. Patients will perform this exercise for eight weeks, and at the end of eight weeks, individuals' pain, kinesiophobia, and fragility will be assessed. No studies have been found in the literature where hand and foot exercises were applied to patients with diabetic neuropathy in combination with VR or cold application. In our study, hand and foot exercises are planned to be applied to patients in both the cold application and virtual reality intervention groups. This will ensure that patients feel relaxed after exercise and that multiple non-pharmacological methods are used simultaneously. As a result of all these interventions, patients' pain levels and kinesiophobia will be assessed.
Interventions
BEHAVIORALExercises and cold application
Hand and foot exercises combined with cold application interventions are non-pharmacological methods used to reduce pain, kinesiophobia, and fragility levels in patients with diabetic peripheral neuropathy.
OTHERExercises and virtual reality
Performing hand and foot exercises in a cold, snowy virtual environment using virtual reality goggles may be a non-pharmacological intervention to alleviate burning-type hand and foot pain in patients with diabetic neuropathy.
Sponsors
Sakarya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
In terms of the reliability of the study results, patients in this study will be divided into groups using a stratified randomization method. Patients will be randomly assigned to two intervention (I) and one control (C) groups according to their age.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Those who volunteer to participate in the study * Those who have been diagnosed with diabetes at least 6 months ago * Those who show symptoms of neuropathy * Those over the age of 18 * Those without cognitive or psychiatric diagnoses * Those who are open to communication and cooperation * Those who use a smartphone
Exclusion criteria
* Those with neurological disorders other than neuropathy * Those with any additional orthopedic or systemic disorders that would prevent them from performing the exercises * Those who have had a lower extremity pathology (surgery, fracture, soft tissue injury, etc.) in the past 6 months * Those who are pregnant during the study period * Those who wish to withdraw from the study of their own accord
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in kinesiophobia | At the end of eight weeks | As a result of the intervention, the Tampa Kinesiophobia Scale will be used to evaluate the differences and effects between the intervention and control groups in terms of fear of movement levels. The Turkish validity and reliability study of the scale developed by Miller and colleagues (1991) was conducted by Yılmaz and colleagues (2011). The TKÖ is a 17-item scale developed to measure fear of movement/re-injury. Each question in the scale uses a 4-point Likert scale (1 = Strongly disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Strongly agree). The total score obtained from the questionnaire ranges from 17 to 68. A high score on the scale indicates a high level of kinesiophobia. |
| Change in the neuropathic pain levels | at the end of eight weeks | Following an eight-week intervention, the Douleur Neuropathique en 4-DN4 questionnaire will be used to assess whether there has been a reduction in patients' neuropathic pain levels. The DN4 pain questionnaire, developed by a neuropathic pain group, consists of four questions that inquire about the characteristics, type, location, and aggravating factors of neuropathic pain. According to the scale, neuropathic pain is assessed with a total of four questions, the first two of which are based on direct interviews with the patient and the last two on the patient's clinical examination. The Turkish validity and reliability study was conducted by Ünal Çevik and colleagues (2010). The questions in the questionnaire are answered with yes or no. Each 'yes' answer is scored as 1 point, and each no answer is scored as 0 points. According to the scale, the threshold value for neuropathic pain is set at 4/10 or higher. |
| Change in fraility | At the end of eight weeks | As a result of the intervention, the fragility levels of patients with diabetic peripheral neuropathy will be assessed using the Tilburg Fraility Scale. The Turkish validity and reliability study of the scale developed by Gobbens and colleagues (2010) was conducted by Arslan and colleagues (2018). The TKÖ consists of 15 questions and 3 sub-dimensions that assess vulnerability. The scale includes 8 questions that assess the physical domain, 4 questions that assess the psychological domain, and 3 questions that assess the social domain. Eleven items of the TKÖ are evaluated in two categories: Yes and No. Four items of the TKÖ are scored as yes, sometimes, and no. The total score that can be obtained from the scale ranges from 0 to 15, with scores of 5 and above indicating the presence of vulnerability. |
Countries
Turkey (Türkiye)
Outcome results
None listed