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Focal Vibrations and Neuropathic Pain in Diabetic Peripheral Neuropathy

Primary Purpose

Peripheral Neuropathy, Diabetic Neuropathies

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Focal muscle vibration
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Pain, Neuropathy, Diabetes

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Wazir Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Arm 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

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

TENS with pulse width 250ms, intensity 14Hz for 30 minutes Exercise therapy: Stretching Exercise to: Calf Hamstring Quadriceps

Outcomes

Primary Outcome Measures

Short Form McGill Pain Questionnaire
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.
Short Form McGill Pain Questionnaire
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.
Short Form McGill Pain Questionnaire
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

Full Information

First Posted
March 30, 2022
Last Updated
March 7, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05322746
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Diabetic Neuropathies
Keywords
Pain, Neuropathy, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm 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
Arm Title
Group B
Arm Type
Active Comparator
Arm 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
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
TENS with pulse width 250ms, intensity 14Hz for 30 minutes Exercise therapy: Stretching Exercise to: Calf Hamstring Quadriceps
Intervention Type
Device
Intervention Name(s)
Focal muscle vibration
Intervention Description
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 Outcome Measure Information:
Title
Short Form McGill Pain Questionnaire
Description
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.
Time Frame
0 week
Title
Short Form McGill Pain Questionnaire
Description
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.
Time Frame
4 weeks
Title
Short Form McGill Pain Questionnaire
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirza Obaid O Baig, MSPT(NMR)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wazir Memorial Hospital
City
Toba Tek Singh
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31197153
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.
Results Reference
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PubMed Identifier
32507132
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.
Results Reference
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PubMed Identifier
33266464
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.
Results Reference
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PubMed Identifier
33801216
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.
Results Reference
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Focal Vibrations and Neuropathic Pain in Diabetic Peripheral Neuropathy

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