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

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. ^{1 2 3 4 5}

Is electrical stimulation safe for humans?

Electrical stimulation techniques like NMES and FES have been used safely in humans for various conditions, including spinal cord injuries and muscle strengthening. Some discomfort may occur, but no major safety concerns have been reported in the studies reviewed. ^{2 4 6 7 8}

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. ^{1 2 9 10 11}

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

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

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

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Electrical stimulation for investigating and improving neuromuscular function in vivo: Historical perspective and major advances. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Motor point heatmap of the calf. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of Functional Electrical Stimulation Lower Extremity Training in Myotonic Dystrophy Type I: A Pilot Controlled Study. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation-Induced Resistance Training After SCI: A Review of the Dudley Protocol. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Therapeutic electrical stimulation to improve motor control and functional abilities of the upper extremity after stroke: a systematic review. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Sensory transcutaneous electrical stimulation fails to decrease discomfort associated with neuromuscular electrical stimulation in healthy individuals. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Motor Neuroprostheses. [2019]