Focal Vibrations and Neuropathic Pain in Diabetic Peripheral Neuropathy

Effects of Focal Vibrations on Neuropathic Pain in Diabetic Peripheral Neuropathy

Most of the literature found on whole body vibrations(WBV) instead of focal muscle vibrations (FMV) in diabetic peripheral neuropathy patients. The studies found on the effects of focal vibrations could not be generalised on the huge population of diabetes mellitus (DM) induced neuropathic pain because of small sample size and due to subordinate studies i.e, pilot studies done on the focal vibrations in which 3 different modes of vibrations is used without comparing with the control group. These studies are not much valuable in literature as well as for clinical purposes due to lack of control group. As mentioned in previous studies that better results achieved with the WBV on pain in diabetic peripheral neuropathyso that the hypothesis can be made that when FMV directly applies on the focal region that may influence the pain and/or peripheral neuropathy status.

Study Overview

• Status: Completed
• Conditions: Diabetic Neuropathies; Peripheral Neuropathy
• Intervention / Treatment: Device: Focal muscle vibration

Detailed Description

Diabetic neuropathy is the most common complication associated with diabetes mellitus, affecting approximately 50-70% of patients with diabetes. The prevalence of pain and of paraesthesia were 20% and 33% 10 years after diagnosis of diabetes mellitus (DM). DPN is the leading cause for disability due to foot ulceration and amputation and significantly lowers quality of life (QoL). Neuropathic pain is caused by a lesion or disease of the somatosensory system, including peripheral fibres (Aβ, Aδ and C fibres) and central neurons. Thus the prevalence of DPN and limitations of current studies make evident the need for future research.The study going to be taken with a large sample size, further testing the efficacy of FMV as a treatment for DPN and also check the detraining effects after discontinuation of therapy for 1 month so that the gaps in the literature can be full filled

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Toba Tek Singh, Punjab, Pakistan
      • Wazir Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diabetic type II patients.
• Score >12 at Leeds Assessment of Neuropathic Symptoms & Signs (LANSS)
• Diagnosis of diabetic peripheral neuropathy, using previous history, physical examination and vibration perception test of the patients
• Post diabetic duration of 10 years
• Patient with lower limb pain ranges from 3 to 5 on short form McGill pain

Exclusion Criteria:

• Lower extremity amputation
• Neuropathy other than diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Focal Muscle vibration will be apply to: Tibialis anterior; The distal quadriceps; Belly of the gastrocnemius/soleus muscles.; Sinusoidal vibration intensity range 120 Hz.; Each muscle will vibration for 10 minutes; 10 minutes per muscle duration; total 30 minutes	Device: Focal muscle vibration; Focal muscle vibration (FMV) defined as a technique that applies a vibratory stimulus to a specific muscle or its tendon using a mechanical device. FMV generates the Ia inputs as a consequence of the activation primary ending of the muscle spindle leading to alteration of corticospinal pathways results in activation of Ia inputs by FMV. The vibration of a specific muscle can increase the motor evoked potential, enhance the changes in corticospinal excitability and produces involuntary contraction in the vibrated muscle
Active Comparator: Group B; Focal Muscle vibration similar to Group A with following: Conventional Therapy TENS with pulse width 250ms, intensity 14Hz for 30 minutes Exercise therapy: Stretching Exercise to: Calf; Hamstring; Quadriceps	Device: Focal muscle vibration; Focal muscle vibration (FMV) defined as a technique that applies a vibratory stimulus to a specific muscle or its tendon using a mechanical device. FMV generates the Ia inputs as a consequence of the activation primary ending of the muscle spindle leading to alteration of corticospinal pathways results in activation of Ia inputs by FMV. The vibration of a specific muscle can increase the motor evoked potential, enhance the changes in corticospinal excitability and produces involuntary contraction in the vibrated muscle
Active Comparator: Group C; TENS with pulse width 250ms, intensity 14Hz for 30 minutes Exercise therapy: Stretching Exercise to: Calf; Hamstring; Quadriceps	Device: Focal muscle vibration; Focal muscle vibration (FMV) defined as a technique that applies a vibratory stimulus to a specific muscle or its tendon using a mechanical device. FMV generates the Ia inputs as a consequence of the activation primary ending of the muscle spindle leading to alteration of corticospinal pathways results in activation of Ia inputs by FMV. The vibration of a specific muscle can increase the motor evoked potential, enhance the changes in corticospinal excitability and produces involuntary contraction in the vibrated muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form McGill Pain Questionnaire	Short Form McGill Pain Questionnaire is used to assess the non-neuropathic or neuropathic pain and describe the different qualities of pain and related symptoms. It has 0 to 10 scale, with 0 begin no pain and 10 begin worst pain.	0 week
Short Form McGill Pain Questionnaire	Short Form McGill Pain Questionnaire is used to assess the non-neuropathic or neuropathic pain and describe the different qualities of pain and related symptoms. It has 0 to 10 scale, with 0 begin no pain and 10 begin worst pain.	4 weeks
Short Form McGill Pain Questionnaire	Short Form McGill Pain Questionnaire is used to assess the non-neuropathic or neuropathic pain and describe the different qualities of pain and related symptoms. It has 0 to 10 scale, with 0 begin no pain and 10 begin worst pain.	8 weeks

Collaborators and Investigators

• Sponsor: Riphah International University

Publications and helpful links

General Publications

• Feldman EL, Callaghan BC, Pop-Busui R, Zochodne DW, Wright DE, Bennett DL, Bril V, Russell JW, Viswanathan V. Diabetic neuropathy. Nat Rev Dis Primers. 2019 Jun 13;5(1):41. doi: 10.1038/s41572-019-0092-1.
• Rippetoe J, Wang H, James SA, Dionne C, Block B, Beckner M. Improvement of Gait after 4 Weeks of Wearable Focal Muscle Vibration Therapy for Individuals with Diabetic Peripheral Neuropathy. J Clin Med. 2020 Nov 22;9(11):3767. doi: 10.3390/jcm9113767.
• Chandrashekhar R, Wang H, Dionne C, James S, Burzycki J. Wearable Focal Muscle Vibration on Pain, Balance, Mobility, and Sensation in Individuals with Diabetic Peripheral Neuropathy: A Pilot Study. Int J Environ Res Public Health. 2021 Mar 2;18(5):2415. doi: 10.3390/ijerph18052415.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Pain; Neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Neuralgia; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: REC01225 Sameen Tahir

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