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NCT Number: NCT05322746

Focal Vibrations and 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.

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Key information

Conditions

Peripheral Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wazir Memorial Hospital

Toba Tek Singh, Punjab Province, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focal muscle vibration

Device

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

Primary outcomes

  1. Short Form McGill Pain Questionnaire

    Time frame: 0 week

    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.

  2. Short Form McGill Pain Questionnaire

    Time frame: 4 weeks

    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.

  3. Short Form McGill Pain Questionnaire

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Focal Vibrations on Neuropathic Pain in Diabetic Peripheral Neuropathy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2022
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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