Electrical Stimulation for Cubital Tunnel Syndrome
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alberta
Disqualifiers: Concurrent nerve injury, prior CuTS surgery, others
Stay on Your Current Meds
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
Cubital tunnel syndrome is the second most common compression neuropathy. In severe cases, functional recovery, even with surgery, is often poor. Therefore, alternative adjunct treatments capable of increasing the speed of nerve regeneration are much needed.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of this treatment for Cubital Tunnel Syndrome?
Research shows that neuromuscular electrical stimulation (NMES) is effective in strengthening weak muscles and improving recovery after surgeries like anterior cruciate ligament reconstruction. This suggests that similar electrical stimulation techniques might help improve muscle function in conditions like Cubital Tunnel Syndrome.12345
Is electrical stimulation safe for humans?
How does electrical stimulation differ from other treatments for cubital tunnel syndrome?
Electrical stimulation for cubital tunnel syndrome is unique because it uses electrical currents to activate muscles and nerves, potentially improving muscle function and reducing discomfort. Unlike traditional treatments that may focus on surgery or physical therapy alone, this approach aims to enhance muscle control and function through targeted electrical impulses.1291011
Eligibility Criteria
This trial is for adults over 18 with severe Cubital Tunnel Syndrome (CuTS), confirmed by specific grades and tests showing significant nerve damage in the hand muscles. It's not open to those with other nerve injuries, previous CuTS surgery, or additional neurological conditions.Inclusion Criteria
I am older than 18 years.
If electrophysiologic evidence of severe motor axonal loss with motor unit number estimation (MUNE) greater than 2 standard deviations below the normative mean.
If needle EMG examination showed evidence of chronic motor axonal loss and reduced recruitment in the ulnar-innervated intrinsic hand muscles
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Exclusion Criteria
I do not have any neurological conditions.
I do not have a current nerve injury.
I have not had surgery for CuTS.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-surgery Conditioning
Patients in the stimulation group receive 1 hour of 20 Hz electrical stimulation 7 days prior to surgery
1 week
Surgery
Participants undergo cubital tunnel surgery
1 day
Post-surgery Recovery
Participants recover from surgery and are monitored for physiological and functional improvements
3 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 years
Treatment Details
Interventions
- Conditioning Electrical Stimulation (Other)
Trial OverviewThe study is testing if electrical stimulation can help people recover better from severe CuTS. Participants will receive this treatment as an add-on to see if it speeds up nerve regeneration compared to usual care alone.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Conditioning electrical stimulationExperimental Treatment1 Intervention
Patients in the stimulation group will receive surgery as well as 1 hour of 20 Hz electrical stimulation 7 days prior to surgery
Group II: ControlActive Control1 Intervention
Control patients will receive cubital tunnel surgery and sham stimulation.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of AlbertaEdmonton, Canada
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Who Is Running the Clinical Trial?
University of AlbertaLead Sponsor
References
Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. [2019]Purpose: In response to requests from physiotherapists for guidance on optimal stimulation of muscle using neuromuscular electrical stimulation (NMES), a review, synthesis, and extraction of key data from the literature was undertaken by six Canadian physical therapy (PT) educators, clinicians, and researchers in the field of electrophysical agents. The objective was to identify commonly treated conditions for which there was a substantial body of literature from which to draw conclusions regarding the effectiveness of NMES. Included studies had to apply NMES with visible and tetanic muscle contractions. Method: Four electronic databases (CINAHL, Embase, PUBMED, and SCOPUS) were searched for relevant literature published between database inceptions until May 2015. Additional articles were identified from bibliographies of the systematic reviews and from personal collections. Results: The extracted data were synthesized using a consensus process among the authors to provide recommendations for optimal stimulation parameters and application techniques to address muscle impairments associated with the following conditions: stroke (upper or lower extremity; both acute and chronic), anterior cruciate ligament reconstruction, patellofemoral pain syndrome, knee osteoarthritis, and total knee arthroplasty as well as critical illness and advanced disease states. Summaries of key details from each study incorporated into the review were also developed. The final sections of the article outline the recommended terminology for describing practice using electrical currents and provide tips for safe and effective clinical practice using NMES. Conclusion: This article provides physiotherapists with a resource to enable evidence-informed, effective use of NMES for PT practice.
Comparison of maximum tolerated muscle torques produced by 2 pulse durations. [2014]Neuromuscular electrical stimulation (NMES) is an effective therapeutic technique for strengthening weak muscles. A positive dose-response relationship exists between the elicited muscle forces during training and strength (force-generating capacity) gains. Patient discomfort limits NMES muscle forces, potentially compromising efficacy.
Emerging techniques in orthopedics: advances in neuromuscular electrical stimulation. [2016]Neuromuscular electrical stimulation (NMES) is defined as the application of an electric current to neuromuscular tissue to elicit a muscle contraction. It is typically applied in a clinical setting to strengthen muscle, particularly the quadriceps femoris, through repetitive contractions. Most studies to date involving NMES have been conducted using conventional lead-wired, or "single path" devices, and while effective, these devices have inherent limitations around comfort and incomplete muscle recruitment. In a prospective, randomized, controlled, single-blind trial, investigators found that using a novel "Multipath" device was effective when combined with standard rehabilitation in accelerating recovery after anterior cruciate ligament reconstruction. Additional research is warranted to explore whether this effect also occurs after other types of knee surgery.
Utilizing the reaction of degeneration test for individuals with focal paralysis. [2021]Neuromuscular electrical stimulation (NMES) is a modality sometimes used to help strengthen weak muscles. On occasion, however, the targeted muscles do not respond to the current delivered. No response to electrical stimulation should raise the consideration of unsuspected peripheral nerve damage. Two case studies are presented showing how absence of response was due to unsuspected peripheral neuropathy, which had not been considered in either of the original referral diagnoses.
Electrical stimulation for investigating and improving neuromuscular function in vivo: Historical perspective and major advances. [2023]This historical review summarizes the major advances - particularly from the last 50 years - in transcutaneous motor-level electrical stimulation, which can be used either as a tool to investigate neuromuscular function and its determinants (electrical stimulation for testing; EST) or as a therapeutic/training modality to improve neuromuscular and physical function (neuromuscular electrical stimulation; NMES). We focus on some of the most important applications of electrical stimulation in research and clinical settings, such as the investigation of acute changes, chronic adaptations and pathological alterations of neuromuscular function with EST, as well as the enhancement, preservation and restoration of muscle strength and mass with NMES treatment programs in various populations. For both EST and NMES, several major advances converge around understanding and optimizing motor unit recruitment during electrically-evoked contractions, also taking into account the influence of stimulation site (e.g., muscle belly vs nerve trunk) and type (e.g., pulse duration, frequency, and intensity). This information is equally important both in the context of mechanistic research of neuromuscular function as well as for clinicians who believe that improvements in neuromuscular function are required to provide health-related benefits to their patients.
Motor point heatmap of the calf. [2023]Contractions of muscles in the calf induced by neuromuscular electrical stimulation (NMES) may prevent venous thromboembolism, help rehabilitation and optimize strength training, among other uses. However, compliance to NMES-treatment is limited by the use of suboptimal stimulation points which may cause discomfort and less effectivity. Knowledge of where one is most likely to find muscle motor points (MP) could improve NMES comfort and compliance.
Effects of Functional Electrical Stimulation Lower Extremity Training in Myotonic Dystrophy Type I: A Pilot Controlled Study. [2018]Functional electrical stimulation (FES) is a new rehabilitative approach that combines electrical stimulation with a functional task. This pilot study evaluated the safety and effectiveness of FES lower extremity training in myotonic dystrophy type 1.
Neuromuscular Electrical Stimulation-Induced Resistance Training After SCI: A Review of the Dudley Protocol. [2018]Neuromuscular electrical stimulation (NMES), often referred to as functional electrical stimulation (FES), has been used to activate paralyzed skeletal muscle in people with spinal cord injury (SCI). The goal of NMES has been to reverse some of the dramatic losses in skeletal muscle mass, to stimulate functional improvements in people with incomplete paralysis, and to produce some of the health benefits associated with exercise.
Therapeutic electrical stimulation to improve motor control and functional abilities of the upper extremity after stroke: a systematic review. [2018]Therapeutic electrical stimulation (TES) is a therapeutic strategy aimed at improving impairments of the upper extremity in stroke.
Sensory transcutaneous electrical stimulation fails to decrease discomfort associated with neuromuscular electrical stimulation in healthy individuals. [2016]Sensory transcutaneous electrical nerve stimulation (TENS) is frequently used for pain modulation. Neuromuscular electrical stimulation used to induce strong muscle contractions is often limited by muscular discomfort and by discomfort associated with the electrical current. The objective of this study was to determine whether the application of TENS can reduce the discomfort associated with neuromuscular electrical stimulation, leading to stronger maximal electrically induced contractions.
Motor Neuroprostheses. [2019]Neuroprostheses (NPs) are electrical stimulators that activate nerves, either to provide sensory input to the central nervous system (sensory NPs), or to activate muscles (motor NPs: MNPs). The first MNPs were belts with inbuilt batteries and electrodes developed in the 1850s to exercise the abdominal muscles. They became enormously popular among the general public, but as a result of exaggerated therapeutic claims they were soon discredited by the medical community. In the 1950s, MNPs reemerged for the serious purpose of activating paralyzed muscles. Neuromuscular electrical stimulation (NMES), when applied in a preset sequence, is called therapeutic electrical stimulation (TES). NMES timed so that it enhances muscle contraction in intended voluntary movements is called functional electrical stimulation (FES) or functional neuromuscular stimulation (FNS). It has been 50 years since the first FES device, a foot-drop stimulator, was described and 40 years since the first implantable version was tested in humans. A commercial foot-drop stimulator became available in the 1970s, but for various reasons, it failed to achieve widespread use. With advances in technology, such devices are now more convenient and reliable. Enhancing upper limb function is a more difficult task, but grasp-release stimulators have been shown to provide significant benefits. This chapter deals with the technical aspects of NMES, the therapeutic and functional benefits of TES and FES, delayed-onset and carryover effects attributable to "neuromodulation" and the barriers and opportunities in this rapidly developing field. © 2019 American Physiological Society. Compr Physiol 9:127-148, 2019.