Buerger Exercises With Whole Body Vibration in Diabetic Peripheral Neuropathy

NCT06737861 | Completed DMC

• 1 other identifier: REC/0262 Malaika Shahid
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathic Pain; Balance Changes; Ankle Brachial Index

Keywords

Buerger Exercises; Whole Body Vibration Therapy; Diabetic peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Ankle Brachial Index (ABI)

  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 Outcomes (2)

• Numeric Pain rating Scale (NPRS)

  Assessment at baseline after, 4th, 8th, 12th and 16th week

• Mini-Balance Evaluation Systems Test (Mini-BESTest)

  Assessment at baseline after, 4th, 8th, 12th and 16th week

Other Outcomes (1)

• Timed Up and Go Test (TUGT)

  Assessment at baseline, after 4th, 8th, 12th and 16th weeks

Study Arms (2)

Group A

EXPERIMENTAL

Buerger exercises and Whole Body Vibration (WBV) exercise group

Other: Group A

Group B

ACTIVE COMPARATOR

Buerger exercises group

Other: Group B

Interventions

Group A OTHER

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.

Also known as: Buerger exercises with Whole Body Vibration

Group A

Group B OTHER

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.

Also known as: Buerger exercises

Group B

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Social Security Hospital in Sialkot

Sialkot, Punjab Province, Pakistan

Location

Related Publications (6)

• Akbari NJ, Naimi SS. The effect of exercise therapy on balance in patients with diabetic peripheral neuropathy: a systematic review. J Diabetes Metab Disord. 2022 Jul 4;21(2):1861-1871. doi: 10.1007/s40200-022-01077-1. eCollection 2022 Dec.

  PMID: 36404857 BACKGROUND

• Gomes-Neto M, de Sa-Caputo DDC, Paineiras-Domingos LL, Brandao AA, Neves MF, Marin PJ, Sanudo B, Bernardo-Filho M. Effects of Whole-Body Vibration in Older Adult Patients With Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. Can J Diabetes. 2019 Oct;43(7):524-529.e2. doi: 10.1016/j.jcjd.2019.03.008. Epub 2019 Mar 27.

  PMID: 31104903 BACKGROUND

• Ahmad AM, Mohammed AA, Khalifa WA, Ali HM, Abdel-Aziz A. Effect of Buerger-Allen exercise on wound healing in patients with diabetic foot ulcers: a randomised controlled trial. J Wound Care. 2024 Apr 2;33(Sup4a):xci-xcviii. doi: 10.12968/jowc.2024.33.Sup4a.xci.

  PMID: 38588058 BACKGROUND

• Kessler NJ, Lockard MM, Fischer J. Whole body vibration improves symptoms of diabetic peripheral neuropathy. J Bodyw Mov Ther. 2020 Apr;24(2):1-3. doi: 10.1016/j.jbmt.2020.01.004. Epub 2020 Feb 11.

  PMID: 32507132 BACKGROUND

• Jamal A, Ahmad I, Ahamed N, Azharuddin M, Alam F, Hussain ME. Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. J Diabetes Metab Disord. 2019 Dec 21;19(1):61-69. doi: 10.1007/s40200-019-00476-1. eCollection 2020 Jun.

  PMID: 32550157 BACKGROUND

• Radhika J, Poomalai G, Nalini S, Revathi R. Effectiveness of Buerger-Allen Exercise on Lower Extremity Perfusion and Peripheral Neuropathy Symptoms among Patients with Diabetes Mellitus. Iran J Nurs Midwifery Res. 2020 Jun 17;25(4):291-295. doi: 10.4103/ijnmr.IJNMR_63_19. eCollection 2020 Jul-Aug.

  PMID: 33014740 BACKGROUND

Study Officials

• Aruba Saeed, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: interventional study model for this study is a parallel-group randomized controlled trial (RCT). This model involves two distinct groups: Intervention Group: Participants receive both Buerger exercises and Whole Body Vibration (WBV) therapy. Control Group: Participants receive only Buerger exercises without WBV therapy. Each participant is assigned randomly to one of these groups, ensuring that comparisons between the combined therapy and single therapy are unbiased. This parallel structure means each group undergoes its specific intervention throughout the study period without crossover to the other group's intervention. This approach helps assess the distinct and combined effects of the two therapies on pain, balance, and lower limb perfusion in patients with diabetic peripheral neuropathy.

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: December 20, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)