The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy

Study Overview
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Brief Summary
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The study will be carried out to determine the effect on pain and quality of life between the groups that received and did not receive foot and ankle exercise training.

Detailed Description
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In the literature, in patients with diabetic neuropathy who received foot and ankle exercise training; It is observed that it reduces the level of pain and increases the quality of life. Foot and ankle exercise training given to the participants improved blood circulation, improved foot-ankle range of motion, increased foot muscle strength and function, improved diabetic neuropathy symptoms, redistributed plantar pressure during movement, improved sensitivity, and was effective in maintaining balance; It is thought that participants can reduce pain and improve their quality of life with foot and ankle exercise training. While there are studies examining the effect of non-pharmacological interventions such as spa treatment and pulse electromagnetic field therapy in patients with diabetic neuropathy in our country, no study has been found examining the effect of foot and ankle exercise training on pain and quality of life in patients with diabetic neuropathic pain. It is thought that the results of the research will be beneficial in symptom management and improve quality of life in addition to pharmacological treatment.

Official Title
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The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy

Conditions
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Diabetic Neuropathy, Painful

Intervention / Treatment
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* Other: foot and ankle exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and over, Having been diagnosed with Type 2 diabetes for at least one year, Diagnosed with diabetic peripheral neuropathy for at least 6 months by EMG by a neurologist, Individuals with diabetes mellitus with neuropathic pain who score 12 or higher on the S-Lanns (Self-Leeds Assessment of Neuropathic Symptoms and Sign) pain scale, Visual Analogue Scale (VAS) value to be at least 1, Receiving medical treatment for diabetic neuropathy, Did not receive physical therapy and non-pharmacological treatment during the research period, Having no physical and mental problems that will prevent communication, Having blood glucose meters at home, Individuals with smart device use, Exclusion Criteria: Peripheral vascular complications due to diabetes or another etiology, Having a history of surgery on the knee, ankle and hip and indication for surgery during the intervention period, Those who cannot communicate on the phone (with hearing problems), Having nephropathy, retinopathy and diabetic foot, Neurological diseases (stroke, cerebrovascular diseases, epilepsy) and serious musculoskeletal problems (rheumatoid arthritis, osteoarthritis) Neurocognitive disorder (Alzheimer's disease, dementia), Not taking any physical therapy during the intervention period, Patients with deep vein thrombosis, femur fractures, surgical conditions, open wounds

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Experimental research method was used. There is an intervention and control group. While the intervention group was given foot and ankle exercise training, no intervention was given to the control group. The Visual Analog Scale (VAS) of Neuropathic Pain was calculated by another researcher, who applied foot and ankle exercises to both groups before starting the exercise (1st measurement), fourth (2nd measurement) and at the end of the eighth week (3rd measurement). The Impact on Quality of Life Questionnaire (NePIQoL) was administered.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>The intervention group received training by sending foot and ankle exercise videos to their mobile phones via WhatsApp. | Other: foot and ankle exercise<br>* Foot and Ankle Exercise Phase Pulling the foot upwards from the ankle Bending the foot down from the ankle Spreading the feet like a fan, moving the toes in and out to the right and left Circle drawing exercise with ankle Towel folding exercise Bottle rolling exercise under the feet (The water in the bottle will be warm tap water)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain level at 4th and 8th weeks compared to baseline. | Pain scores of the patients were checked after foot and ankle exercise training. The scale, developed by Price, McGrath, Rafii, and Buckingham, is a measurement tool that evaluates pain severity. The scale is 10 cm long and is graded on a horizontal line (0 = no pain, 10 = most severe pain). The patient is asked to mark a point on this line that corresponds to the intensity of pain he feels. The marked numerical value indicates the severity of the patient's perception of pain. A VAS value of 1 to 4 indicates mild pain, 5-6 indicates moderate pain, and 7-10 indicates severe pain. As scores increase, the level of pain worsens and general health deteriorates. | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of neuropathic pain on quality of life at 4 and 8 weeks change from initial state | After the interventions, the patient's scores on the effect of neuropathic pain on quality of life are checked. Poole, Murphy, and Nurmka (2009) developed a questionnaire on the impact of neuropathic pain on quality of life. The scale consisting of 42 items; symptoms were divided into 6 subscales under the headings of relationships, psychological, social activity, physical activity, and personal/self care. The results of the questionnaire on the effect of neuropathic pain on the quality of life were calculated by summing the 42-item scores. The total score range is between 42 and 210. The score range for each item is between 1 and 5. | Two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic neuropathic pain, exercise, foot and ankle, pain, quality of life