Physiotherapy + FES for Cervical Radiculopathy

(C-FIVE Trial)

Overseen By Abrity Gomes, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Cardiovascular conditions, Neurological diseases, Mental illness, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding functional electrical stimulation (FES-t) to regular physiotherapy improves recovery from C5 palsy, a nerve issue causing shoulder and arm weakness after neck surgery. Participants will receive either physiotherapy alone or a combination of physiotherapy and FES-t. Individuals with persistent C5 palsy for at least three months following neck surgery may qualify for this trial. As an unphased trial, it offers a unique opportunity to explore innovative treatment options that could enhance 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. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining functional electrical stimulation therapy (FES-t) with physiotherapy is generally safe. Although specific safety data for FES-t in cervical radiculopathy (a condition causing neck pain and nerve issues) is limited, studies have found that similar treatments, such as transcutaneous electrical stimulation, can reduce neck pain. This suggests that FES-t might be well-tolerated.

While further research is needed to confirm these findings, FES-t in other conditions has not shown major safety concerns. Prospective trial participants may find this information helpful in understanding the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of functional electrical stimulation therapy (FES-t) with conventional physiotherapy for cervical radiculopathy because it offers a novel approach that could enhance recovery. Unlike the standard of care, which typically involves physiotherapy alone, this treatment adds FES-t to stimulate muscles through electrical impulses, potentially accelerating healing and improving muscle function. This combined approach aims to provide more effective rehabilitation by not only addressing symptoms but also enhancing neuromuscular re-education, which could lead to better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for cervical radiculopathy?

Research has shown that combining functional electrical stimulation therapy (FES-t) with physiotherapy can effectively reduce neck pain in people with cervical issues. In this trial, one group of participants will receive both FES-t and conventional physiotherapy, while another group will receive physiotherapy alone. Studies have found that patients receiving both treatments experience more pain relief than those undergoing only physiotherapy. For instance, one study found that patients who had FES-t reported a greater reduction in pain levels. This suggests that adding FES-t to physiotherapy might lead to better results for those with ongoing C5 palsy. However, more research is needed to confirm these findings. ^{1 2 3 5 6}

Who Is on the Research Team?

Julio C Furlan, MD,PhD

Principal Investigator

KITE-TRI, University Health Network & University of Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

Significant persisting mental illness

I cannot join an intensive outpatient rehab program.

I have a frozen shoulder with limited movement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either conventional physiotherapy alone or combined conventional physiotherapy and FES-t along with task-specific training

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Conventional physiotherapy
• Functional electrical stimulation therapy (FES-t)

Trial Overview 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.

How Is the Trial Designed?

Group I: FES-t along with conventional physiotherapy Experimental Treatment 2 Interventions

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

Group II: Conventional physiotherapy alone Active Control 1 Intervention

Conventional physiotherapy alone (current standard of care)

Conventional physiotherapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Physical therapy for:

• Musculoskeletal disorders
• Neurological conditions
• Cardiovascular diseases
• Respiratory conditions

Approved in United States as Physical therapy for:

• Musculoskeletal disorders
• Neurological conditions
• Cardiovascular diseases
• Respiratory conditions
• Pediatric conditions

Approved in Canada as Physiotherapy for:

• Musculoskeletal disorders
• Neurological conditions
• Cardiovascular diseases
• Respiratory conditions

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

A 35-year-old male with cervical radiculopathy experienced complete symptom resolution after receiving cervical spine thrust manipulation, highlighting its efficacy in treating this condition.

The patient's functional scores improved significantly, with a DASH score reduction from 40 to 2 and a PSFS improvement from 1.66 to 9.66, demonstrating the safety and effectiveness of thrust manipulation alongside non-thrust mobilization techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical spine thrust and non-thrust mobilization for the management of recalcitrant C6 paresthesias associated with a cervical radiculopathy: a case report. Hagan, CR., Anderson, AR.[2022]

In a study involving 81 patients with cervical radiculopathy, adding mechanical cervical traction to a treatment plan of manual therapy and exercise did not provide any significant additional benefits in reducing pain or improving function after 4 weeks.

Both treatment groups showed similar outcomes on pain and disability measures, indicating that mechanical cervical traction may not be necessary for effective management of cervical radiculopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual therapy, exercise, and traction for patients with cervical radiculopathy: a randomized clinical trial. Young, IA., Michener, LA., Cleland, JA., et al.[2022]

This study investigates the effectiveness of a 4-week physiotherapy program, including manual therapy and exercise, for patients with acute and sub-acute cervical radiculopathy, compared to a control group receiving only phone advice, involving 64 participants.

The trial aims to assess improvements in pain and disability over 12 weeks, with outcomes measured by blinded assessors, and seeks to identify predictors of treatment success, highlighting the importance of structured physiotherapy in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy - the PACeR trial protocol. Keating, L., Treanor, C., Sugrue, J., et al.[2020]

In a study of 60 patients with cervical radiculopathy, those treated with a 5% lidocaine medicated plaster experienced faster relief from pain symptoms compared to those receiving mesotherapy, which is crucial for timely rehabilitation.

Both treatment methods were effective in managing pain, but the quicker symptom control with lidocaine allows for earlier initiation of physiotherapy, potentially improving overall recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Conservative treatment of cervical radiculopathy with 5% lidocaine medicated plaster]. Mattozzi, I.[2019]

In a study of 38 patients with cervical radiculopathy, the Patient Specific Functional Scale (PSFS) demonstrated high test-retest reliability (ICC = 0.82) and was more responsive to changes in patient condition compared to the Neck Disability Index (NDI), which had moderate reliability (ICC = 0.68).

The minimal detectable change was lower for the PSFS (2.1) than for the NDI (10.2), indicating that the PSFS can detect smaller changes in patient function, making it a more sensitive tool for assessing improvements in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The reliability and construct validity of the Neck Disability Index and patient specific functional scale in patients with cervical radiculopathy. Cleland, JA., Fritz, JM., Whitman, JM., et al.[2022]

In a randomized control trial involving 36 patients with cervical radiculopathy, mechanical traction combined with segmental mobilization and exercise therapy was found to be more effective in reducing pain and disability compared to manual traction.

Both mechanical and manual traction techniques showed statistically significant improvements in pain and disability, but mechanical traction resulted in greater clinical outcomes, suggesting it may be the preferred method for managing cervical radiculopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between effectiveness of Mechanical and Manual Traction combined with mobilization and exercise therapy in Patients with Cervical Radiculopathy. Bukhari, SR., Shakil-Ur-Rehman, S., Ahmad, S., et al.[2020]

In a pilot study involving 20 patients treated by Canadian orthopaedic manual physiotherapists, adverse events from cervical manipulation and mobilization were mostly benign and transient, with 95.6% occurring within 0-12 hours and lasting 0-2 days.

The study faced significant challenges in recruitment and data collection, highlighting the need for improved methods in future larger trials, but it confirmed that no serious adverse events were reported during the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining adverse events in patients with neck pain receiving orthopaedic manual physiotherapy: a pilot and feasibility study. Carlesso, LC., Macdermid, JC., Santaguida, PL., et al.[2021]

In a study of 202 patients with cervical radiculopathy undergoing surgery, no significant differences were found between structured postoperative physiotherapy and standard care at the 6-month follow-up, although all patients showed improvement from baseline.

Patients who attended at least 50% of the structured physiotherapy sessions experienced greater improvements in pain coping strategies, suggesting that while both approaches are effective, higher engagement in physiotherapy may enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neck-Related Physical Function, Self-Efficacy, and Coping Strategies in Patients With Cervical Radiculopathy: A Randomized Clinical Trial of Postoperative Physiotherapy. Wibault, J., Öberg, B., Dedering, Å., et al.[2019]

There is low-level evidence suggesting that cervical manipulation and mobilization can effectively reduce pain and improve range of motion in patients with cervical radiculopathy, but these interventions were primarily studied in single randomized clinical trials.

A combination of spinal mobilization and motor control exercises may be more effective for reducing pain and activity limitations compared to separate treatments or a wait-and-see approach, indicating that multimodal strategies could be beneficial for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of manual therapy for cervical radiculopathy, a review. Thoomes, EJ.[2019]

A systematic review of 59 trials involving 4108 participants found very-low certainty evidence that conservative treatments like acupuncture, prednisolone, and cervical manipulation may provide short-term relief for pain and disability in adults with cervical radiculopathy.

The review highlighted a significant lack of high-quality evidence for the effectiveness of conservative interventions compared to surgery, indicating a need for further research to better understand treatment options for cervical radiculopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative Management of Cervical Radiculopathy: A Systematic Review. Plener, J., Csiernik, B., To, D., et al.[2023]

Cervical manipulation and mobilization techniques for neck pain are generally effective but can be associated with rare serious adverse events, as highlighted by a review of studies from 1998 to 2009.

The review found that while 17 out of 76 studies reported no major adverse events, minor adverse events like transient neurological symptoms and increased neck pain were noted, indicating a need for better reporting of adverse events in manual therapy research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with the use of cervical manipulation and mobilization for the treatment of neck pain in adults: a systematic review. Carlesso, LC., Gross, AR., Santaguida, PL., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6039622/

Effectiveness of percutaneous neuromuscular electrical ... This study found that PNMES can reduce neck pain in patients with CS effectively. However, further studies are still needed to warrant the ...

2. journals.lww.com journals.lww.com/md-journal/fulltext/2018/06290/effectiveness_of_percutaneous_neuromuscular.9.aspx

Effectiveness of percutaneous neuromuscular electrical... This study found that PNMES can reduce neck pain in patients with CS effectively. However, further studies are still needed to warrant the present results.

3. withpower.com withpower.com/trial/phase-c5-palsy-2-2022-5d53f

Physiotherapy + FES for Cervical Radiculopathy This trial compares regular physiotherapy with a combined approach using exercises, electrical stimulation, and activity practice to help patients with ...

4. mdpi.com mdpi.com/2075-1729/15/11/1690

Assessment and Rehabilitation in Cervical Radiculopathy ... Results: Both groups showed significant improvements, but the SG demonstrated greater reductions in pain (median VAS change: 8.16 ± 0.72 vs. 5.11 ± 0.70, p < ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11864000/

a double-blinded, two-arm parallel randomized controlled trial It was concluded that active tDCS along with TENS and exercise intervention was effective on pain, disability, and quality of life in patients with cervical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7464773/

Effects of Neuromuscular Electrical Stimulation (NMES) Plus ... NMES plus upper cervical spine mobilization can be regarded as a promising method to improve swallowing function and forward head posture changes in stroke ...