Back to resultsEffects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy
Primary Purpose
Diabetic Peripheral Neuropathy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Routine Physical Therapy
Vibration Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring Diabetes Mellitus, Vibration Therapy, Diabetic Neuropathy, Pain, Balance, Functional Disability, Patient satisfaction, Routine Physical Therapy
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
Sites / Locations
- The University of Lahore
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ROUTINE PHYSICAL THERAPY GROUP
VIBRATION THERAPY
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05580705
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
February 22, 2023 (Actual)
Study Completion Date
February 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
Keywords
Diabetes Mellitus, Vibration Therapy, Diabetic Neuropathy, Pain, Balance, Functional Disability, Patient satisfaction, Routine Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
It will be a single blinded study and the outcome assessor will be blinded to the treatment group
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ROUTINE PHYSICAL THERAPY GROUP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
VIBRATION THERAPY
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Physical Therapy
Intervention Description
The Routine Physiotherapy treatment will include Transcutaneous Electrical Nerve Stimulation, Hot pack, Range of Motion (ROM) Exercises and Muscle Strengthening Exercises
Intervention Type
Other
Intervention Name(s)
Vibration Therapy
Intervention Description
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 Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
Change in pain score will be measured at baseline, at the end of 1st week and 2nd week.
Title
Dynamic and Static Balance
Description
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.
Time Frame
Change in Balance score will be measured at baseline, at the end of 1st week and 2nd week.
Title
Level of Functional Disability
Description
Functional Disability will be measured by using Revised Neuropathy Disability Score. The total score is 10 with higher score indicates more severity of disease.
Time Frame
Change in Functional Disability score will be measured at baseline, at the end of 1st week and 2nd week
Title
Patient Satisfaction Level
Description
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.
Time Frame
Change in Patient Satisfaction Level will be measured at baseline, at the end of 1st week and 2nd week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
The University of Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Immediately after publication
IPD Sharing Time Frame
Beginning 9 months and ending on 36th month
Learn more about this trial
Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy
We'll reach out to this number within 24 hrs