Electrical Stimulation for Cubital Tunnel Syndrome
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Alberta
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.
Is electrical stimulation a promising treatment for Cubital Tunnel Syndrome?Electrical stimulation is a promising treatment because it can help improve muscle strength and control, which is beneficial for conditions affecting the arms, like Cubital Tunnel Syndrome. It has been shown to help with muscle impairments and enhance muscle function, making it a valuable option for therapy.12389
What safety data exists for electrical stimulation treatments?The safety data for electrical stimulation treatments, such as NMES and FES, indicates that while these methods can be effective for muscle strengthening and rehabilitation, patient discomfort and compliance are concerns. Discomfort can limit the effectiveness of NMES, and optimal stimulation points can improve comfort and compliance. Additionally, the absence of muscle response to stimulation may indicate peripheral nerve damage, as shown in case studies. A pilot study on FES for myotonic dystrophy type 1 evaluated its safety and effectiveness, suggesting it is a promising rehabilitative approach.246710
Do I have to stop taking my current medications for this trial?The trial information does not specify whether you need to stop taking your current medications.
What data supports the idea that Electrical Stimulation for Cubital Tunnel Syndrome is an effective treatment?The available research shows that Electrical Stimulation, specifically Neuromuscular Electrical Stimulation (NMES), is effective in strengthening weak muscles and improving muscle function. Although the studies primarily focus on conditions like stroke, knee surgeries, and muscle impairments, they demonstrate that NMES can enhance muscle strength and recovery. For example, a study found that NMES, when combined with standard rehabilitation, accelerated recovery after knee surgery. This suggests that similar benefits might be seen in treating Cubital Tunnel Syndrome, as it also involves muscle and nerve function.245811
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.
Exclusion Criteria
I do not have any neurological conditions.
I do not have a current nerve injury.
I have not had surgery for CuTS.
Treatment Details
The 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.
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
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.