Clinical trial NCT05322746: Focal Vibrations and Neuropathic Pain in Diabetic Peripheral Neuropathy
Official title: Effects of Focal Vibrations on Neuropathic Pain in Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Diabetic Neuropathies
Keywords: Pain
Neuropathy
Diabetes
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 96
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Short Form McGill Pain Questionnaire
timeFrame: 0 week
measure: Short Form McGill Pain Questionnaire
timeFrame: 4 weeks
measure: Short Form McGill Pain Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toba Tek Singh
country: Pakistan
facility: Wazir Memorial Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mirza Obaid O Baig, MSPT(NMR)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feldman EL, Callaghan BC, Pop-Busui R, Zochodne DW, Wright DE, Bennett DL, Bril V, Russell JW, Viswanathan V. Diabetic neuropathy. Nat Rev Dis Primers. 2019 Jun 13;5(1):41. doi: 10.1038/s41572-019-0092-1.
citation: Kessler NJ, Lockard MM, Fischer J. Whole body vibration improves symptoms of diabetic peripheral neuropathy. J Bodyw Mov Ther. 2020 Apr;24(2):1-3. doi: 10.1016/j.jbmt.2020.01.004. Epub 2020 Feb 11.
citation: Rippetoe J, Wang H, James SA, Dionne C, Block B, Beckner M. Improvement of Gait after 4 Weeks of Wearable Focal Muscle Vibration Therapy for Individuals with Diabetic Peripheral Neuropathy. J Clin Med. 2020 Nov 22;9(11):3767. doi: 10.3390/jcm9113767.
citation: Chandrashekhar R, Wang H, Dionne C, James S, Burzycki J. Wearable Focal Muscle Vibration on Pain, Balance, Mobility, and Sensation in Individuals with Diabetic Peripheral Neuropathy: A Pilot Study. Int J Environ Res Public Health. 2021 Mar 2;18(5):2415. doi: 10.3390/ijerph18052415.