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Focal Vibrations and Neuropathic Pain in Diabetic Peripheral Neuropathy

Not Applicable
Completed
Conditions
Peripheral Neuropathy
Diabetic Neuropathies
Interventions
Device: Focal muscle vibration
Registration Number
NCT05322746
Lead Sponsor
Riphah International University
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
96
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
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Exclusion Criteria
  • Lower extremity amputation
  • Neuropathy other than diabetes
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group CFocal muscle vibrationTENS with pulse width 250ms, intensity 14Hz for 30 minutes Exercise therapy: Stretching Exercise to: 1. Calf 2. Hamstring 3. Quadriceps
Group AFocal muscle vibrationFocal Muscle vibration will be apply to: 1. Tibialis anterior 2. The distal quadriceps 3. Belly of the gastrocnemius/soleus muscles. 4. Sinusoidal vibration intensity range 120 Hz. 5. Each muscle will vibration for 10 minutes 6. 10 minutes per muscle duration; total 30 minutes
Group BFocal muscle vibrationFocal 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: 1. Calf 2. Hamstring 3. Quadriceps
Primary Outcome Measures
NameTimeMethod
Short Form McGill Pain Questionnaire8 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Wazir Memorial Hospital

🇵🇰

Toba Tek Singh, Punjab, Pakistan

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