Clinical trial NCT05580705: Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy
Official title: Effects of Vibration Therapy in Addition to Routine Physical Therapy on Pain, Balance, Functional Disability and Satisfaction in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: Diabetes Mellitus
Vibration Therapy
Diabetic Neuropathy
Pain
Balance
Functional Disability
Patient satisfaction
Routine Physical Therapy
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Intensity
timeFrame: Change in pain score will be measured at baseline, at the end of 1st week and 2nd week.
measure: Dynamic and Static Balance
timeFrame: Change in Balance score will be measured at baseline, at the end of 1st week and 2nd week.
measure: Level of Functional Disability
timeFrame: Change in Functional Disability score will be measured at baseline, at the end of 1st week and 2nd week
measure: Patient Satisfaction Level
timeFrame: Change in Patient Satisfaction Level will be measured at baseline, at the end of 1st week and 2nd week.
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore
state: Punjab
Study officials:
References: