Diabetic Peripheral NeuropathyNCT05580705
Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy
A study testing Routine Physical Therapy and Vibration Therapy in people with Diabetic Peripheral Neuropathy, run by University of Lahore at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Routine Physical Therapy and Vibration Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Sep 2022to 22 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Vibration Therapy in Addition to Routine Physical Therapy on Pain, Balance, Functional Disability and Satisfaction 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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Routine Physical Therapy, Vibration Therapy
- Keywords
- Diabetes Mellitus, Vibration Therapy, Diabetic Neuropathy, Pain, Balance, Functional Disability, Patient satisfaction, Routine Physical Therapy
- Medical subject headings
- Diabetes Mellitus, Diabetic Neuropathies, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Physical TherapyOther
The Routine Physiotherapy treatment will include Transcutaneous Electrical Nerve Stimulation, Hot pack, Range of Motion (ROM) Exercises and Muscle Strengthening Exercises
Vibration TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ROUTINE PHYSICAL THERAPY GROUP | Active comparator | 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. Receives: Other: Routine Physical Therapy |
| VIBRATION THERAPY | Experimental | 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. Receives: Other: Vibration Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in pain score will be measured at baseline, at the end of 1st week and 2nd week.
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.
Measured: Change in Balance score will be measured at baseline, at the end of 1st week and 2nd week.
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.
Measured: Change in Functional Disability score will be measured at baseline, at the end of 1st week and 2nd week
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.
Measured: Change in Patient Satisfaction Level will be measured at baseline, at the end of 1st week and 2nd week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start22 Sep 2022
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Jamil, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580705
- Sponsor's protocol ID
- Sajawal Bashir
- Status last verified
- Apr 2023
- First submitted
- 11 Oct 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Immediately after publication
Publications
Bashir S, Jamil A, Ali S. Effects of vibration therapy with routine physical therapy on pain, balance, and functional disability in diabetic neuropathy patients: a randomised controlled trial. J Pak Med Assoc. 2025 Apr;75(4):534-539. doi: 10.47391/JPMA.20058.
PubMed 40269358
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vibration Therapy in Addition to Routine Physical Therapy on Pain, Balance, Functional Disability and Satisfaction in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05580705
- Acronym / sponsor ID
- Sajawal Bashir
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Diabetes Mellitus, Vibration Therapy, Diabetic Neuropathy, Pain, Balance, Functional Disability, Patient satisfaction, Routine Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROUTINE PHYSICAL THERAPY GROUP | Active comparator | Other: Routine Physical TherapyThis 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. |
| VIBRATION THERAPY | Experimental | Other: Vibration TherapyThis 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Physical TherapyThe Routine Physiotherapy treatment will include Transcutaneous Electrical Nerve Stimulation, Hot pack, Range of Motion (ROM) Exercises and Muscle Strengthening Exercises | Other | ROUTINE PHYSICAL THERAPY GROUP |
| Vibration TherapyVibration 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. | Other | VIBRATION THERAPY |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 40269358Bashir S, Jamil A, Ali S. Effects of vibration therapy with routine physical therapy on pain, balance, and functional disability in diabetic neuropathy patients: a randomised controlled trial. J Pak Med Assoc. 2025 Apr;75(4):534-539. doi: 10.47391/JPMA.20058.
- Individual participant dataSharing planned: Yes. Immediately after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Physical Therapy and Vibration Therapy in people with Diabetic Peripheral Neuropathy, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Change in pain score will be measured at baseline, at the end of 1st week and 2nd week.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05580705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.