Focal Vibrations and Neuropathic Pain in Diabetic Peripheral Neuropathy

R

Riphah International University

Status

Completed

Conditions

Peripheral Neuropathy
Diabetic Neuropathies

Treatments

Device: Focal muscle vibration

Study type

Interventional

Funder types

Other

Identifiers

NCT05322746
REC01225 Sameen Tahir

Details and patient eligibility

About

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.

Full 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

Enrollment

96 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 3 patient groups

Group A
Experimental group
Description:
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
Treatment:
Device: Focal muscle vibration
Group B
Active Comparator group
Description:
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
Treatment:
Device: Focal muscle vibration
Group C
Active Comparator group
Description:
TENS with pulse width 250ms, intensity 14Hz for 30 minutes Exercise therapy: Stretching Exercise to: Calf Hamstring Quadriceps
Treatment:
Device: Focal muscle vibration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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