What side effects are associated with this type of intervention?

Common side effects of electrical stimulation therapies for Cervical Radiculopathy, such as Functional Electrical Stimulation (FES-t), include mild device-associated adverse events like a warm sensation, numbness in the arm or hand, redness, itching, tingling, muscle spasms, arm pain, shoulder pain, and neck pain. Serious adverse events are rare.

What prior FDA approvals exist?

The FDA has approved various treatments for cervical radiculopathy, including pharmacologic therapies like NSAIDs, corticosteroids, and muscle relaxants. For treatments involving electrical stimulation, Transcutaneous Electrical Nerve Stimulation (TENS) is a notable FDA-approved method used to manage pain by delivering electrical impulses to nerves. While specific FDA approvals for Functional Electrical Stimulation (FES-t) in cervical radiculopathy are not detailed, similar neuromodulation techniques like spinal cord stimulation (SCS) have been approved for chronic pain management, which may offer insights into the potential benefits of FES-t.

What other types of research exist?

Promising novel alternatives to Functional Electrical Stimulation (FES-t) for Cervical Radiculopathy patients include: 1) Spinal Cord Stimulation (SCS) using high-frequency or burst waveforms, which has shown effectiveness in managing chronic pain and improving motor function. 2) Deep Brain Stimulation (DBS), particularly targeting the globus pallidus internus, which has been effective in managing dystonia and motor function in cerebral palsy and may have potential applications in cervical radiculopathy. 3) Selective Dorsal Rhizotomy (SDR), a neurosurgical procedure that reduces spasticity by cutting selective nerve roots in the spinal cord, which could be considered for severe cases. These alternatives offer different mechanisms of action and may provide relief for patients not responding to conventional FES-t.

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Other

Physiotherapy + FES for Cervical Radiculopathy (C-FIVE Trial)

N/A

Recruiting

Led By Julio C Furlan, MD,PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

New unilateral or bilateral, persistent C5 palsy (for at least 3 months) after surgical treatment for degenerative cervical myelopathy

Be older than 18 years old

Must not have

Inability to participate in an intensive outpatient rehabilitation program

Reduced passive range of motion (ROM) of the shoulder ("frozen shoulder")

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 to10 weeks post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial compares regular physiotherapy with a combined approach using exercises, electrical stimulation, and activity practice to help patients with persistent C5 palsy improve their muscle function and movement.

Who is the study for?

This trial is for people who have had persistent C5 palsy for at least 3 months after neck surgery. It's not suitable for those with substance abuse issues, other medical conditions that limit treatment, contraindications to FES-t, severe mental illness, learning disabilities, or uncontrolled heart problems.

What is being tested?

The study is testing if adding Functional Electrical Stimulation therapy (FES-t) to conventional physiotherapy helps improve movement and nerve function in patients with C5 palsy more than physiotherapy alone.

What are the potential side effects?

While the side effects are not detailed here, typical ones from physical therapies may include muscle soreness or fatigue. FES-t might cause skin irritation or discomfort where the electrical pads are placed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had persistent arm weakness for 3 months after neck surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot join an intensive outpatient rehab program.

Select...

I have a frozen shoulder with limited movement.

Select...

My heart condition is not well-managed.

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I have a neurological condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 to10 weeks post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 to10 weeks post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 to10 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Spinal Cord Independence Measure (SCIM) score

Secondary study objectives

Change in Functional Magnetic Resonance Imaging (MRI)

Change in Manual muscle testing

Change in neurophysiological parameters

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FES-t along with conventional physiotherapyExperimental Treatment2 Interventions

Combined conventional physiotherapy and functional electrical stimulation therapy (FES-t) along with task-specific training

Group II: Conventional physiotherapy aloneActive Control1 Intervention

Conventional physiotherapy alone (current standard of care)

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Cervical Radiculopathy that involve electrical stimulation, such as Functional Electrical Stimulation (FES-t), work by delivering electrical impulses to specific muscles or nerves. This stimulation helps to activate muscles, improve motor function, and reduce pain by enhancing blood flow and promoting muscle strength and coordination. For patients with Cervical Radiculopathy, these treatments are crucial as they can alleviate symptoms, improve functional recovery, and enhance the overall quality of life by addressing both the neurological and muscular components of the condition.