Diabetic Peripheral Neuropathy
Conditions
Keywords
Diabetes Mellitus, Vibration Therapy, Diabetic Neuropathy, Pain, Balance, Functional Disability, Patient satisfaction, Routine Physical Therapy
Brief summary
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.
Detailed description
Peripheral Diabetic Neuropathy has disastrous effects on human body. It causes impairment which makes normal functioning and activity of daily life difficult. Vibration therapy improves neural mechano-sensitivity to promote movement and function. In Pakistan, researches have been conducted only on Whole-body vibration and no data is available on foot-sole vibration therapy which is convenient to apply and appropriate for patients as there will be no fear of fall associated during treatment. Therefore, the aim of this study is to analyze the effects of vibration therapy, applied locally on foot, on pain management, balance adjustment, function and satisfaction to treatment in patients with diabetic neuropathy.
Interventions
OTHERRoutine Physical Therapy
The Routine Physiotherapy treatment will include Transcutaneous Electrical Nerve Stimulation, Hot pack, Range of Motion (ROM) Exercises and Muscle Strengthening Exercises
OTHERVibration Therapy
Vibration Therapy will include a vibration device of brand Manipol, model number RK-001. It has 360 degree off-centered axis with a frequency of 2500 times per minute. It will be applied on sole of the foot for about 15 mins.
Sponsors
University of Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
It will be a single blinded study and the outcome assessor will be blinded to the treatment group
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Change in pain score will be measured at baseline, at the end of 1st week and 2nd week. | 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. |
| Dynamic and Static Balance | Change in Balance score will be measured at baseline, at the end of 1st week and 2nd week. | 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. |
| Level of Functional Disability | Change in Functional Disability score will be measured at baseline, at the end of 1st week and 2nd week | Functional Disability will be measured by using Revised Neuropathy Disability Score. The total score is 10 with higher score indicates more severity of disease. |
| Patient Satisfaction Level | Change in Patient Satisfaction Level will be measured at baseline, at the end of 1st week and 2nd week. | 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. |
Countries
Pakistan
Outcome results
None listed