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Clinical Trials/NCT05580705
NCT05580705
Completed
N/A

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

University of Lahore1 site in 1 country72 target enrollmentSeptember 22, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetic Peripheral Neuropathy
Sponsor
University of Lahore
Enrollment
72
Locations
1
Primary Endpoint
Pain Intensity
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 22, 2022
End Date
February 22, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Lahore
Responsible Party
Principal Investigator
Principal Investigator

Ayesha Jamil

Assistant Professor

University of Lahore

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain Intensity

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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