- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05322746
Focal Vibrations and Neuropathic Pain in Diabetic Peripheral Neuropathy
March 7, 2023 updated by: Riphah International University
Effects of Focal Vibrations on Neuropathic Pain in Diabetic Peripheral Neuropathy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sameen Tahir, DPT
- Phone Number: +923067146420
- Email: sameentahir00@gmail.com
Study Contact Backup
- Name: Mirza Obaid Baig, MSPT(NMPR)
- Phone Number: +923332238706
- Email: obaid.baig@riphah.edu.pk
Study Locations
-
-
Punjab
-
Toba Tek Singh, Punjab, Pakistan
- Wazir Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
Focal Muscle vibration will be apply to:
|
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
|
Active Comparator: Group B
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:
|
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
|
Active Comparator: Group C
TENS with pulse width 250ms, intensity 14Hz for 30 minutes Exercise therapy: Stretching Exercise to:
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Form McGill Pain Questionnaire
Time Frame: 0 week
|
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.
|
0 week
|
Short Form McGill Pain Questionnaire
Time Frame: 4 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.
|
4 weeks
|
Short Form McGill Pain Questionnaire
Time Frame: 8 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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 28, 2022
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
February 28, 2023
Study Registration Dates
First Submitted
March 30, 2022
First Submitted That Met QC Criteria
April 11, 2022
First Posted (Actual)
April 12, 2022
Study Record Updates
Last Update Posted (Estimate)
March 9, 2023
Last Update Submitted That Met QC Criteria
March 7, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC01225 Sameen Tahir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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