Diabetic Peripheral Neuropathy Clinical Trial
Official title:
Effects of Vibration Therapy in Addition to Routine Physical Therapy on Pain, Balance, Functional Disability and Satisfaction in Patients With Diabetic Neuropathy
Verified date | April 2023 |
Source | University of Lahore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is aimed to determine the effects of sole-foot vibration therapy on pain intensity, static and dynamic balance, functional status and satisfaction to the intervention applied on patients with peripheral neuropathy due to type 2 diabetes mellitus.
Status | Completed |
Enrollment | 72 |
Est. completion date | February 22, 2023 |
Est. primary completion date | February 22, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age of 40-75 years - Both male and female participants - On oral medicine for diabetes - HbA1C <8.5%, and controlled blood sugar in the last three months - Patients with < 6 years from diagnosis of diabetes - Diagnosed patient of peripheral neuropathy having type 2 diabetes by registered medical practitioner - Patient is able to stand on both feet. Exclusion Criteria: - Systemic diseases such as advanced cardiovascular, renal, or hepatic diseases - Open wounds/ulcers on lower limb - Neurological illness that affects balance i.e. vertebral artery syndrome, Multiple Sclerosis, Parkinson's disease, Alzheimer's disease, Stroke and cerebral ataxia - Musculoskeletal problems such as leg length discrepancy, ankle sprain and severe osteoarthritis of knee and hip joints - Patients who have performed vibration therapy exercises prior to intervention - Patient under any antihypertensive drugs and blood pressure more than 160/95 mm hg |
Country | Name | City | State |
---|---|---|---|
Pakistan | The University of Lahore | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
University of Lahore |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Intensity | Pain Intensity will be measured by using Numeric Pain Rating Scale. Pain score range from 1-10, with 1 indicates least possible pain level and 10 is the worst pain level. | Change in pain score will be measured at baseline, at the end of 1st week and 2nd week. | |
Primary | Dynamic and Static Balance | Dynamic and static balance will be measured by using Berg Balance Scale. Its score range from 0 to 56, lower score represents more chances of losing balance and requirement of assistive measures. | Change in Balance score will be measured at baseline, at the end of 1st week and 2nd week. | |
Primary | Level of Functional Disability | Functional Disability will be measured by using Revised Neuropathy Disability Score. The total score is 10 with higher score indicates more severity of disease. | Change in Functional Disability score will be measured at baseline, at the end of 1st week and 2nd week | |
Primary | Patient Satisfaction Level | Patient Satisfaction Level will be measured by the Patient Satisfaction Questionnaire. Total score is 90. and higher score towards maximum value indicates higher level of satisfaction. | Change in Patient Satisfaction Level will be measured at baseline, at the end of 1st week and 2nd week. |
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