Buerger Exercises With Whole Body Vibration in Diabetic Peripheral Neuropathy

August 18, 2025 updated by: Riphah International University

Effects of Buerger Exercises With Whole Body Vibration on Pain, Balance and Lower Limb Perfusion in Patients With Diabetic Peripheral Neuropathy

The goal of this clinical trial is to determine if a combined intervention of Buerger exercises and whole-body vibration therapy can improve pain, circulation, and balance in adults with diabetic peripheral neuropathy.

Participants will:

Perform Buerger exercises three times daily in both groups. Receive whole-body vibration therapy three times per week (intervention group only).

Complete assessments at baseline, the 4th, 8th, 12th weeks, and a follow-up at the 16th week.

Outcome measures include pain rating, ankle-brachial index, balance scale, and timed mobility test. Statistical analyses will assess within-group and between-group effects based on data distribution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study, titled "Effects of Buerger Exercises with Whole Body Vibration on Pain, Balance, and Lower Limb Perfusion in Patients with Diabetic Peripheral Neuropathy," aims to assess the combined effectiveness of Buerger exercises and Whole-Body Vibration (WBV) therapy in addressing diabetic peripheral neuropathy (DPN). DPN is a common complication of diabetes mellitus, affecting roughly 50% of diabetic individuals globally and leading to sensory impairments, pain, mobility issues, and an elevated risk for severe foot complications. In Pakistan, where a large population suffers from diabetes, there is an urgent need for effective interventions for DPN. Existing research has shown that Buerger exercises alone are beneficial in improving lower limb circulation, the ankle-brachial index, and capillary refill time, while also reducing neuropathy risk by promoting blood circulation to the lower limbs. Separately, WBV therapy has demonstrated improvements in sensory perception, neuropathy scores, balance, and quality of life, as well as enhanced muscle strength and reflex responses through motor unit activation. Despite this evidence, the combined effect of these two interventions has not been studied extensively, creating a research gap regarding their potential synergistic benefits. This study seeks to fill that gap by evaluating outcomes in pain, balance, and circulation among DPN patients receiving both interventions, with the hypothesis that the combination may be more effective than Buerger exercises alone.

This randomized controlled trial (RCT) will be conducted at Civil Hospital Sialkot and Social Security Hospital Sialkot and is expected to last ten months. Participants, aged 50-70 and diagnosed with DPN, will be randomly assigned to two groups: an intervention group that receives both Buerger exercises and WBV therapy, and a control group performing only Buerger exercises. WBV therapy sessions will occur three times weekly at a frequency of 25 Hz, each lasting 12 minutes with a protocol of four 3-minute bouts. The Buerger exercises will be performed daily by both groups, with three cycles per session and three sessions per day. Outcomes will be measured using the Numeric Pain Rating Scale (NPRS) for pain assessment, the Ankle-Brachial Index (ABI) for lower limb perfusion, the Berg Balance Scale (BBS) for balance, and the Timed Up and Go Test (TUGT) for functional mobility. Data collection will take place at baseline, the 4th, 8th, and 12th weeks, and there will be a follow-up at the 16th week to determine if the benefits are sustained.

The study will recruit participants who meet specific inclusion criteria, such as having an HbA1c level higher than 6.7 mmol/L and MNSI scores indicating DPN, while excluding those with severe pain, cardiovascular conditions, deep vein thrombosis, or advanced diabetes complications like diabetic foot. A single-blinded approach will be used to ensure that outcome assessors are not aware of the participant's group allocation. Data will be analyzed using SPSS-27, with normality checks via Kolmogorov-Smirnov and Shapiro-Wilk tests. If data is normally distributed, within-group comparisons will use Repeated Measures ANOVA and between-group comparisons will use one-way ANOVA; if data is not normally distributed, the Mann-Whitney U test will be used for between-group comparisons and the Friedman test for within-group comparisons.

This study is significant in that it will address a clinical gap by evaluating the combined impact of Buerger exercises and WBV therapy on pain, balance, and circulation in individuals with DPN. If successful, it could offer a more effective treatment option to improve quality of life and functionality in this patient population. The study timeline includes major milestones such as title approval, synopsis defense, data collection, analysis, and a final report, all aimed at completing the study within ten months after approval. Ethical considerations have been meticulously planned, with informed consent processes in both English and Urdu to ensure participants' understanding and voluntary involvement. This research has the potential to provide meaningful insights into a novel intervention strategy for DPN management, which could be beneficial in both clinical practice and future research applications.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Sialkot, Punjab, Pakistan
        • Social Security Hospital in Sialkot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Participants with both genders male and female will be included in the study.
  • The Age limit for the participants will be 50-70 years.
  • Patients diagnosed with diabetes from last 5 Years.
  • The participants with Hb1Ac higher than 6.7mmol/L.
  • Patients diagnosed with diabetic peripheral neuropathy with scores ≥ 4 on Michigan Neuropathy Screening Instrument (MNSI).
  • Patients with Ankle Brachial Index < 1-1.2mmHg.
  • Those patients who were able to participate in exercise interventions.

Exclusion criteria:

  • The patients with Numeric Pain Rating Scale values greater than 4.
  • Patients with severe cardiovascular or musculoskeletal conditions contraindicating exercise.
  • Patients with serious mental problems or inability to communicate.
  • Patients with Deep venous thrombosis.
  • Patients with Diabetic foot ulcers or foot gangrene.
  • Patients having serious complications of diabetes, such as amputation and patients who are unable to complete the entire program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Buerger exercises and Whole Body Vibration (WBV) exercise group
Other: Group A
Participants will perform Buerger exercises three times daily, with each session including three cycles. Additionally, they will receive Whole Body Vibration therapy at a frequency of 25 Hz, three times per week. Each WBV session will last 12 minutes, divided into four 3-minute bouts, aiming to improve pain, balance, and lower limb circulation in diabetic peripheral neuropathy patients.
Other Names:
  • Buerger exercises with Whole Body Vibration
Active Comparator: Group B
Buerger exercises group
Other: Group B
Participants will perform Buerger exercises three times daily, with each session consisting of three cycles. This exercise regimen is aimed at assessing its effectiveness on pain, balance, and circulation in diabetic peripheral neuropathy patients, serving as a comparison to the combined intervention with WBV therapy.
Other Names:
  • Buerger exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle Brachial Index (ABI)
Time Frame: Assessment at baseline after, 4th, 8th, 12th and 16th week
The ABI is a non-invasive measure of lower limb perfusion, calculated as the ratio of ankle systolic blood pressure to brachial systolic blood pressure. An improvement in ABI suggests better blood circulation, which is a key outcome for assessing the intervention's effect on lower limb vascular health.
Assessment at baseline after, 4th, 8th, 12th and 16th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain rating Scale (NPRS)
Time Frame: Assessment at baseline after, 4th, 8th, 12th and 16th week
NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), used to measure the intensity of pain experienced by participants. This self-reported scale helps quantify pain levels and gauge the effectiveness of the intervention on pain reduction.
Assessment at baseline after, 4th, 8th, 12th and 16th week
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: Assessment at baseline after, 4th, 8th, 12th and 16th week

MiniBESTest is 14 items, each scored on a 3-point scale (0 = severe impairment, 2 = normal), with a maximum score of 28.

Covers four balance domains:

Anticipatory postural adjustments (e.g., sit-to-stand, rise on toes) Reactive postural control (compensatory stepping responses) Sensory orientation (balance under altered sensory conditions) Dynamic gait (dual-task walking, pivot turns, speed changes) Lower scores indicate poorer balance and higher fall risk. A cut-off score of ≤19/28 is often used to identify individuals at risk of falls.
Assessment at baseline after, 4th, 8th, 12th and 16th week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go Test (TUGT)
Time Frame: Assessment at baseline, after 4th, 8th, 12th and 16th weeks
TUGT is a functional mobility test where participants are timed as they stand from a seated position, walk 3 meters, turn around, walk back, and sit down. The test assesses mobility and balance, with faster completion times indicating better mobility and balance.
Assessment at baseline, after 4th, 8th, 12th and 16th weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Aruba Saeed, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2024

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/0262 Malaika Shahid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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