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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05580705
• Other study ID #: Sajawal Bashir
• Status: Completed
• Phase: N/A
• Start date: September 22, 2022
• Est. completion date: February 22, 2023

Study information

• Verified date: April 2023
• Source: University of Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• Routine Physical Therapy
The Routine Physiotherapy treatment will include Transcutaneous Electrical Nerve Stimulation, Hot pack, Range of Motion (ROM) Exercises and Muscle Strengthening Exercises
• Vibration 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.

Locations

Country	Name	City	State
Pakistan	The University of Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

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.