Back to resultsThe Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathy, Painful
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
foot and ankle exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetic Neuropathy, Painful focused on measuring Diabetic neuropathic pain, exercise, foot and ankle, pain, quality of life
Eligibility Criteria
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
Sites / Locations
- Toros Devlet Hastanesi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention group
Arm Description
The intervention group received training by sending foot and ankle exercise videos to their mobile phones via WhatsApp.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05670600
Brief Title
The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy
Official Title
The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
August 16, 2021 (Actual)
Study Completion Date
September 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Painful
Keywords
Diabetic neuropathic pain, exercise, foot and ankle, pain, quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
The intervention group received training by sending foot and ankle exercise videos to their mobile phones via WhatsApp.
Intervention Type
Other
Intervention Name(s)
foot and ankle exercise
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in pain level at 4th and 8th weeks compared to baseline.
Description
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.
Time Frame
Two months
Secondary Outcome Measure Information:
Title
Effect of neuropathic pain on quality of life at 4 and 8 weeks change from initial state
Description
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.
Time Frame
Two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ülkü Polat, Prof.
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Selin Çiftçi
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toros Devlet Hastanesi
City
Mersin
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
all IPD underlying results in a publication
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The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy
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