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

Not Applicable
Completed
Conditions
Diabetic Neuropathy, Painful
Interventions
Other: foot and ankle exercise
Registration Number
NCT05670600
Lead Sponsor
Gazi University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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,
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
intervention groupfoot and ankle exerciseThe intervention group received training by sending foot and ankle exercise videos to their mobile phones via WhatsApp.
Primary Outcome Measures
NameTimeMethod
Change in pain level at 4th and 8th weeks compared to baseline.Two months

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.

Secondary Outcome Measures
NameTimeMethod
Effect of neuropathic pain on quality of life at 4 and 8 weeks change from initial stateTwo months

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.

Trial Locations

Locations (1)

Toros Devlet Hastanesi

🇹🇷

Mersin, Turkey

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