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
Research Team
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 Alberta
Lead Sponsor
Trials
957
Patients Recruited
437,000+
Findings from Research
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]
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]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Motor Neuroprostheses.Prochazka, A.[2019]
References
Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. [2019]
Comparison of maximum tolerated muscle torques produced by 2 pulse durations. [2014]
Emerging techniques in orthopedics: advances in neuromuscular electrical stimulation. [2016]
Utilizing the reaction of degeneration test for individuals with focal paralysis. [2021]
Electrical stimulation for investigating and improving neuromuscular function in vivo: Historical perspective and major advances. [2023]
Motor point heatmap of the calf. [2023]
Effects of Functional Electrical Stimulation Lower Extremity Training in Myotonic Dystrophy Type I: A Pilot Controlled Study. [2018]
Neuromuscular Electrical Stimulation-Induced Resistance Training After SCI: A Review of the Dudley Protocol. [2018]
Therapeutic electrical stimulation to improve motor control and functional abilities of the upper extremity after stroke: a systematic review. [2018]
Sensory transcutaneous electrical stimulation fails to decrease discomfort associated with neuromuscular electrical stimulation in healthy individuals. [2016]
Motor Neuroprostheses. [2019]