Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Vibration Therapy in Addition to Routine Physical Therapy on Pain, Balance, Functional Disability and Satisfaction in Patients With Diabetic Neuropathy

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Other: Routine Physical Therapy
* Other: Vibration Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ROUTINE PHYSICAL THERAPY GROUP<br>This group will receive routine physical therapy including strength training intervention. This protocol will be given for two weeks (6 sessions on alternate days, 3 sessions per week), outcomes will be measured at baseline, at the end of 1st week and 2nd week. | Other: Routine Physical Therapy<br>* The Routine Physiotherapy treatment will include Transcutaneous Electrical Nerve Stimulation, Hot pack, Range of Motion (ROM) Exercises and Muscle Strengthening Exercises<br>|
| Experimental: VIBRATION THERAPY<br>This group will receive routine physical therapy and vibration therapy. This protocol will be given for two weeks (6 sessions on alternate days, 3 sessions per week), outcomes will be measured at baseline, at the end of 1st week and 2nd week. | Other: Vibration Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Vibration Therapy, Diabetic Neuropathy, Pain, Balance, Functional Disability, Patient satisfaction, Routine Physical Therapy