Focal Vibrations and Neuropathic Pain in Diabetic Peripheral Neuropathy

NCT05322746 | Completed DMC

• 1 other identifier: REC01225 Sameen Tahir
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy; Diabetic Neuropathies

Keywords

Pain; Neuropathy; Diabetes

Outcome Measures

Primary Outcomes (3)

• 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.

  0 week

• 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.

  4 weeks

• 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.

  8 weeks

Study Arms (3)

Group A

EXPERIMENTAL

Focal Muscle vibration will be apply to: 1. Tibialis anterior 2. The distal quadriceps 3. Belly of the gastrocnemius/soleus muscles. 4. Sinusoidal vibration intensity range 120 Hz. 5. Each muscle will vibration for 10 minutes 6. 10 minutes per muscle duration; total 30 minutes

Device: Focal muscle vibration

Group B

ACTIVE COMPARATOR

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: 1. Calf 2. Hamstring 3. Quadriceps

Device: Focal muscle vibration

Group C

ACTIVE COMPARATOR

TENS with pulse width 250ms, intensity 14Hz for 30 minutes Exercise therapy: Stretching Exercise to: 1. Calf 2. Hamstring 3. Quadriceps

Device: Focal muscle vibration

Interventions

Focal muscle vibration DEVICE

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

Group A; Group B; Group C

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lower extremity amputation
• Neuropathy other than diabetes

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Wazir Memorial Hospital

Toba Tek Singh, Punjab Province, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 31197153 BACKGROUND

• 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.

  PMID: 32507132 BACKGROUND

• 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.

  PMID: 33266464 BACKGROUND

• 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.

  PMID: 33801216 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mirza Obaid O Baig, MSPT(NMR)

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 12, 2022
• Study Start: April 28, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)