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Focal Vibrations and Neuropathic Pain in Diabetic Peripheral Neuropathy

Effects of Focal Vibrations on Neuropathic Pain in Diabetic Peripheral Neuropathy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05322746
Enrollment
96
Registered
2022-04-12
Start date
2022-04-28
Completion date
2023-02-28
Last updated
2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Neuropathy, Diabetic Neuropathies

Keywords

Pain, Neuropathy, Diabetes

Brief summary

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.

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

Interventions

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

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Short Form McGill Pain Questionnaire0 weekShort 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026