Diabetic Neuropathy, Painful Clinical Trial
Official title:
The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy
Verified date | January 2023 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 13, 2021 |
Est. primary completion date | August 16, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Toros Devlet Hastanesi | Mersin |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Turkey,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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