Electrical Stimulation for Cubital Tunnel Syndrome

Overseen By Ming Chan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Concurrent nerve injury, prior CuTS surgery, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether electrical stimulation can aid recovery for people with severe cubital tunnel syndrome after surgery. Cubital tunnel syndrome occurs when a nerve in the elbow becomes compressed, leading to pain and weakness in the hand. The trial compares two groups: one undergoes only surgery, while the other receives electrical stimulation (specifically, Conditioning Electrical Stimulation) before surgery to determine if it accelerates nerve healing. Suitable candidates have severe symptoms and doctor-confirmed nerve damage, without prior surgery for this condition. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for improved recovery.

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 prior data suggests that this electrical stimulation is safe for treating cubital tunnel syndrome?

Research has shown that electrical stimulation has been safely used for conditions like spinal cord injuries and muscle issues. It holds potential for aiding nerve recovery after injury. For instance, studies have found that this therapy can enhance recovery from serious nerve injuries.

In terms of safety, people have tolerated electrical stimulation well. Reports indicate positive outcomes without major side effects. The techniques used align with those tested in various studies, supporting their safe use.

Overall, while more research is always beneficial, existing evidence suggests that electrical stimulation is generally safe for treating nerve problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for cubital tunnel syndrome that primarily rely on surgery alone, conditioning electrical stimulation introduces a new approach. This technique involves using electrical stimulation at 20 Hz for an hour, a week before surgery. Researchers are excited about this because it could enhance nerve recovery and reduce symptoms more effectively than surgery alone. By potentially speeding up recovery and improving outcomes, this method could represent a significant advancement in managing cubital tunnel syndrome.

What evidence suggests that conditioning electrical stimulation is effective for cubital tunnel syndrome?

Research has shown that electrical stimulation, which participants in this trial may receive, can aid nerve healing, crucial for treating cubital tunnel syndrome. Animal studies have found that short bursts of electrical stimulation improve nerve recovery. This technique helps new nerve fibers grow faster, allowing muscles to reconnect with nerves more quickly. Although most findings come from early research, they suggest that electrical stimulation can accelerate recovery from nerve injuries. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

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

I have experienced severe symptoms of CuTS.

Exclusion Criteria

I do not have any neurological conditions.

I do not have a current nerve injury.

I have not had surgery for CuTS.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Conditioning Electrical Stimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: Conditioning electrical stimulation Experimental Treatment 1 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: Control Active Control 1 Intervention

Control patients will receive cubital tunnel surgery and sham stimulation.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

A resistance training form of neuromuscular electrical stimulation (NMES) was successfully applied to individuals with motor complete spinal cord injury, leading to significant increases in muscle mass averaging 30% to 40% over 3 to 6 months of training.

Participants experienced no adverse events and showed consistent progress in their ability to perform more repetitions and lift heavier weights, indicating that NMES can effectively stimulate muscle growth and function even years after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation-Induced Resistance Training After SCI: A Review of the Dudley Protocol. Bickel, CS., Yarar-Fisher, C., Mahoney, ET., et al.[2018]

A novel 'Multipath' neuromuscular electrical stimulation (NMES) device was found to be effective in accelerating recovery after anterior cruciate ligament reconstruction when used alongside standard rehabilitation, as shown in a randomized controlled trial.

Traditional NMES devices have limitations in comfort and muscle recruitment, highlighting the potential advantages of the Multipath device for improving rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging techniques in orthopedics: advances in neuromuscular electrical stimulation. Paessler, HH.[2016]

Neuromuscular electrical stimulation (NMES) may fail to elicit muscle responses due to underlying peripheral nerve damage, as demonstrated in two case studies involving patients with unexpected neuropathies.

Simple reaction of degeneration (R/D) tests can effectively identify nerve lesions, guiding further diagnostic evaluations for patients experiencing significant muscle weakness or paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing the reaction of degeneration test for individuals with focal paralysis. Holland, TJ.[2021]

Therapeutic electrical stimulation (TES) shows a positive effect on improving motor control in stroke patients, with effect sizes ranging from 0.55 to 1.46 in three of the six randomized controlled trials reviewed.

The evidence regarding TES's impact on functional abilities is inconclusive, as only one of the two studies that assessed this outcome reported a positive effect, indicating that more research is needed in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic electrical stimulation to improve motor control and functional abilities of the upper extremity after stroke: a systematic review. de Kroon, JR., van der Lee, JH., IJzerman, MJ., et al.[2018]

A study involving 30 healthy participants mapped the locations of muscle motor points (MPs) in the calf, revealing that the highest probability of finding these points is centrally and medially located, particularly in areas 4 and 29, each with a 50% probability.

The findings suggest that using this MP heatmap can improve the comfort and effectiveness of neuromuscular electrical stimulation (NMES) treatments by optimizing electrode placement, potentially enhancing compliance and therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor point heatmap of the calf. Schriwer, E., Juthberg, R., Flodin, J., et al.[2023]

In a pilot study involving 8 patients with myotonic dystrophy type 1, functional electrical stimulation (FES) training was found to be safe and well-tolerated, leading to significant improvements in muscle strength and endurance compared to conventional training.

FES resulted in a greater increase in tibialis anterior muscle strength (effect size d = 1.583) and overall muscle strength (d = 1.723), suggesting it may be an effective rehabilitative approach for patients with severely compromised muscle function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Functional Electrical Stimulation Lower Extremity Training in Myotonic Dystrophy Type I: A Pilot Controlled Study. Cudia, P., Weis, L., Baba, A., et al.[2018]

In a study involving 10 adults, neuromuscular electrical stimulation (NMES) with a 200-microsecond pulse duration allowed participants to tolerate significantly greater muscle torques compared to a 50-microsecond pulse duration, indicating enhanced efficacy for muscle strengthening.

The findings suggest that medium pulse durations may be more effective for maximizing muscle torque responses, despite the common belief that shorter pulses are preferable due to lower pain thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. Scott, WB., Causey, JB., Marshall, TL.[2014]

A systematic review of literature on neuromuscular electrical stimulation (NMES) identified effective stimulation parameters for treating muscle impairments in conditions like stroke, ACL reconstruction, and knee osteoarthritis, based on a consensus among six Canadian PT experts.

The article serves as a comprehensive resource for physiotherapists, offering evidence-based recommendations and safety tips for the effective application of NMES in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. Nussbaum, EL., Houghton, P., Anthony, J., et al.[2019]

In a study involving 24 young adults, sensory transcutaneous electrical nerve stimulation (TENS) did not significantly reduce discomfort during neuromuscular electrical stimulation or enhance the strength of muscle contractions.

Participants reported more discomfort from the muscle contractions themselves than from the electrical current, indicating that TENS may not be effective for alleviating discomfort in this context, and further research is needed to explore different stimulation parameters in patients with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory transcutaneous electrical stimulation fails to decrease discomfort associated with neuromuscular electrical stimulation in healthy individuals. Laufer, Y., Tausher, H., Esh, R., et al.[2016]

Transcutaneous motor-level electrical stimulation has advanced significantly in the last 50 years, serving both as a research tool to study neuromuscular function and as a therapeutic method to enhance muscle strength and function in various populations.

Key improvements in understanding motor unit recruitment and the effects of stimulation parameters (like pulse duration and intensity) are crucial for optimizing both research outcomes and clinical applications of electrical stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation for investigating and improving neuromuscular function in vivo: Historical perspective and major advances. Maffiuletti, NA., Dirks, ML., Stevens-Lapsley, J., et al.[2023]

Neuroprostheses (NPs) have evolved from early muscle stimulators to advanced devices that can effectively activate paralyzed muscles, with functional electrical stimulation (FES) showing significant benefits in enhancing muscle function, particularly in conditions like foot drop.

Recent advancements in technology have made these devices more convenient and reliable, leading to improved therapeutic outcomes, although challenges remain in enhancing upper limb function compared to lower limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor Neuroprostheses. Prochazka, A.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05395715

Conditioning Electrical Stimulation to Improve Outcomes in ... The effect of brief conditioning electrical stimulation on nerve regeneration has been showed to be efficacy in animal studies. In this double-blind, randomized ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9998520/

Electrical stimulation therapy for peripheral nerve injury - PMC This article aims to explore application methodologies for effective electrical stimulation in the rehabilitation of peripheral nerve injury.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589514124000525

The Role of Electrical Stimulation in Peripheral Nerve ... Early studies of direct electrical stimulation of nerves demonstrated an overall positive effect, with greater axon sprouting, more rapid muscle reinnervation,

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214751921000293

Application of electrical stimulation for peripheral nerve ... In this paper, we review the potential therapeutic benefits of electrical stimulation and the current limitations of regeneration after nerve injury.

5. hand.theclinics.com hand.theclinics.com/article/S0749-0712(24)00019-2/abstract

Electrical Stimulation Chan K.M., Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome, Clinical, Trial: NCT05395715. Google Scholar.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9775635/

The Effect of Electrical Stimulation on Nerve Regeneration ... This study demonstrated the clinical potential of ES therapy to improve patient outcomes following more severe nerve injuries requiring nerve ...

7. withpower.com withpower.com/trial/phase-electrical-stimulation-3-2022-2cb54

Electrical Stimulation for Cubital Tunnel Syndrome Electrical stimulation techniques like NMES and FES have been used safely in humans for various conditions, including spinal cord injuries and muscle ...

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/1545968320962508

Translational Approaches to Electrical Stimulation for ... Extensive animal studies have reported the ability of brief intraoperative electrical stimulation (BES) to enhance functional regeneration after PNI.