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NCT Number: NCT05580705

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

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.

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Key information

Conditions

Diabetic Peripheral Neuropathy Behavior Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Patient Satisfaction Peripheral Nervous System Diseases Signs and Symptoms Treatment Adherence and Compliance

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine physical therapy

Other

The Routine Physiotherapy treatment will include Transcutaneous Electrical Nerve Stimulation, Hot pack, Range of Motion (ROM) Exercises and Muscle Strengthening Exercises

Vibration Therapy

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2022
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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