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Clinical Trials/CTRI/2024/06/068475
CTRI/2024/06/068475
Not yet recruiting
Phase 1

Effect of Plantar Vibration Therapy On Sensation and Nerve Conduction Velocity Of Plantar Nerve In Diabetic Neuropathy

Kratika Dubey1 site in 1 country42 target enrollmentStarted: June 15, 2024Last updated:

Overview

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Kratika Dubey
Enrollment
42
Locations
1
Primary Endpoint
Nerve conduction velocity.

Overview

Brief Summary

Diabetes is a very common condition affecting 101 million population of India in 2021 (1). Chronic diabetes leads to several complications.

Diabetic peripheral neuropathy (DPN) is one of the most common complications of patients with Type 2 diabetes mellitus (T2DM), which affects sensation,  proprioception and somatosensory information.

The symptoms of diabetic neuropathy include reduced sensation, numbness, burning sensation, and pain, especially in the lower extremities due to nerve damage .Tactile sensations mostly affected in this condition.Chronic neuropathy when not managed leads to further complication like diabetic foot.

Currently, diagnosis of diabetic PN is mostly clinical, further confirmed by nerve conduction study (NCS) of peripheral sensory nerves.Plantar nerve is the major nerve supply of  the  distal lower limb.

vibration therapy improves reduces the pain intensity, improves the glycemic control, skin blood flow, muscle strength, which makes it applicable for DPN prevention or for delaying its progression.Localised plantar vibration has shown to improve proprioception and balance in diabetic patients

There are studies which indicates that nerve conduction velocity of plantar nerve is a predictor for diabetic foot which can be caused by chronic peripheral neuropathy.

Predicting diabetic foot in pre-symtomatic stage would aid in foot care and prevent further complications.

Vibration therapy has shown effects on blood flow, strength and flexibility. So there was a need to study if the vibration therapy affects nerve conduction velocity of plantar nerve.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant Blinded

Eligibility Criteria

Ages
35.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Cut off of cut-off of Plantar nerve -SNAP amplitude of 4.55 lV and 2.65 lV Type 2 diabetes mellitus of minimum 8 years Diagnosed DPN for more than 1 year, Age between 35 yr and above.
  • More than 2.5 score in Michigan neuropathy screening instrument.

Exclusion Criteria

  • Patient diagnosed with mental disease.
  • Patients having impaired vibration sensation orthopedic, neurological disorders related to balance disturbances,skin lesions.
  • Bone deformities in the feet.

Outcomes

Primary Outcomes

Nerve conduction velocity.

Time Frame: 1) At the biginning of the study | 2) at the end of the study ( after 3 weeks)

Monofilament for sensation

Time Frame: 1) At the biginning of the study | 2) at the end of the study ( after 3 weeks)

Tuning fork and pin for sensation.

Time Frame: 1) At the biginning of the study | 2) at the end of the study ( after 3 weeks)

• Michigan Neuropathy Screening Instrument

Time Frame: 1) At the biginning of the study | 2) at the end of the study ( after 3 weeks)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Kratika Dubey
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Kratika Dubey

DR. D.Y. Patil College of Physiotherapy

Study Sites (1)

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