Clinical trial NCT05041816: Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy
Official title: Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: focal vibration
wearable
nerve conduction study
pain
mobility
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A 6-week, single group, repeated measures with double baselines research design to characterize the changes in sensory and motor nerve performance in DPN, and examine the relations between these changes and changes in pain and mobility
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the changes in peripheral nerve functions (sensory and motor) in patients with diabetic peripheral neuropathy, and examine the relations between the changes in nerve functions and changes in pain and mobility using focal vibration.

Detailed description: Peripheral nerve impairments are highly prevalent in patients with diabetic peripheral neuropathy (DPN) and are associated with pain and poor mobility. While peripheral sensorimotor nerve function is implicated in neuropathy, the mechanism associated with both pain and mobility is not well understood. Even less understood is the interplay between, and responses to, sensory and motor fibers of the affected peripheral nerve. In our previous study, focal vibration (FV) was effective in reducing pain and improving mobility for only a subgroup of participants with DPN. Because FV stimulates both motor and sensory peripheral nerve fibers, when combined with nerve conduction testing, it offers a unique opportunity to study both the sensory and motor peripheral nerve performance and their contribution to pain and mobility in patients with DPN. We are proposing a single group, repeated measured study to: characterize the changes in sensory and motor peripheral nerve functions; examine the association(s) between these changes and changes in pain and mobility, using FV. If successful, this study will provide us with a better understanding of the role played by sensory and motor nerve impairments in pain and mobility for DPN, and support larger clinical studies to optimize nerve function performance and the FV parameters. We will also explore how changes in the peripheral nerve function associate with severity of DPN.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes for at least one year;
* Diabetic peripheral neuropathy as defined by failure to sense the 5.07 (10g) monofilament test in one or more of the six sites tested;
* Age 45-80 years old;
* Able to ambulate independently without assistive devices (e.g., walker or crutches) for 30 feet;
* No evidence of neurological (other than peripheral neuropathy) or orthopedic conditions;
* Able to understand English instructions;
* Have normal or corrected vision.

Exclusion Criteria:

* With other non-diabetic causes of neuropathy by history;
* Symptomatic peripheral vascular disease, joint pain, swelling and/or limited range of motion in the lower extremities that interfere with walking;
* Other systemic or local diseases that could interfere with walking assessment
* Amputation in the lower extremities;
* Clinically diagnosed with dementia greater than mild (screened using Montreal Cognitive Assessment (MOCA) \<24)

Primary outcomes:
measure: Changes in CMAP
timeFrame: Change from Baseline CMAP measures every 2 weeks for up to 6 weeks
measure: Changes in NCV
timeFrame: Change from Baseline NCV measures every 2 weeks for up to 6 weeks
measure: Changes in SNAP
timeFrame: Change from Baseline SNAP measures every 2 weeks for up to 6 weeks
measure: Changes in BPI-DPN
timeFrame: Change from Baseline BPI-DPN scores every 2 weeks for up to 6 weeks
measure: Changes in TUG
timeFrame: Change from Baseline TUG scores every 2 weeks for up to 6 weeks
measure: Changes in NTSS-6
timeFrame: Change from Baseline NTSS-6 scores every 2 weeks for up to 6 weeks
measure: Changes in NSS
timeFrame: Change from Baseline NSS scores every 2 weeks for up to 6 weeks
measure: Changes in NIS
timeFrame: Change from Baseline NIS scores every 2 weeks for up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Hongwu Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.