Electrical Stimulation for Cubital Tunnel Syndrome

(PHONES Trial)

Recruiting at 4 trial locations

Overseen By Kevin Scanlan, OTR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Checkpoint Surgical Inc.

Disqualifiers: Arrythmia, Congestive heart failure, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for nerve compression. A single dose of the therapeutic stimulation is delivered as part of the surgical intervention to address compression of the ulnar nerve at the elbow.

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.

What data supports the effectiveness of the treatment for cubital tunnel syndrome?

Research shows that postsurgical electrical stimulation (PES) can enhance nerve recovery after surgery for severe cubital tunnel syndrome, suggesting that electrical stimulation therapies like the Checkpoint BEST System may help improve recovery. ^{1 2 3 4 5}

Is electrical stimulation therapy safe for humans?

Transcutaneous electrical nerve stimulation (TENS) and percutaneous electrical nerve stimulation (PENS) are generally considered safe for treating various pain conditions, as they are commonly used in clinical settings and have become popular with both patients and health professionals. ^{6 7 8 9 10}

How is the Checkpoint BEST System treatment different from other treatments for cubital tunnel syndrome?

The Checkpoint BEST System uses electrical stimulation to enhance nerve recovery, which is different from traditional surgical methods that focus on physically decompressing the nerve. This treatment is unique because it promotes axonal regeneration (nerve fiber growth) after surgery, potentially improving recovery outcomes. ^{1 2 4 5 11}

Research Team

Amy M Moore, MD

Principal Investigator

The Ohio State Univeristy Department of Plastic and Reconstructive Surgery

Eligibility Criteria

This trial is for adults aged 18-80 with ulnar nerve compression at the elbow who are scheduled for surgery. They must have signs of muscle weakness or wasting and confirmed ulnar neuropathy through tests. People with severe heart conditions, other nerve injuries in the arm, overall nerve disorders affecting hands, or very weak grip strength cannot join.

Inclusion Criteria

Signed and dated informed consent form

I am eligible for surgery.

Electrodiagnostic evidence of ulnar neuropathy at the elbow

Exclusion Criteria

I experience numbness or pain in my hands.

Previous history or current transection of ulnar nerve, or concomitant upper extremity nerve injury

My unaffected hand's grip strength is under 12kg.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Intervention

Surgical intervention for cubital tunnel decompression with a single, 10-minute dose of electrical stimulation delivered to the ulnar nerve

Single day

1 visit (in-person)

Follow-up

Participants are monitored for nerve healing and functional recovery through various assessments

1 year

Multiple visits at 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

Treatment Details

Interventions

• Checkpoint BEST System

Trial Overview The study is testing a new use of electrical stimulation called Checkpoint BEST System to help heal nerves and improve hand function after surgery for ulnar nerve compression at the elbow. The treatment involves a single dose of stimulation during the surgical procedure.

Participant Groups

Group I: Brief Electrical Stimulation Experimental Treatment 1 Intervention

Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.

Group II: Standard of Care Active Control 1 Intervention

Surgical intervention for cubital tunnel decompression.

Checkpoint BEST System is already approved in United States, European Union for the following indications:

Approved in United States as Checkpoint BEST System for:

• Pain management
• Neuropathic pain
• Chronic low back pain
• Diabetic neuropathy

Approved in European Union as Electrical Stimulation Therapy for:

• Pain management
• Neuropathic pain
• Muscle rehabilitation

Who Is Running the Clinical Trial?

Checkpoint Surgical Inc.

Lead Sponsor

Trials

3

Recruited

220+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Findings from Research

Cubital tunnel syndrome (CTS) is a common condition caused by ulnar nerve compression, leading to symptoms like numbness, tingling, and potential muscle weakness in the hand.

Treatment options for CTS include both nonsurgical methods and various surgical procedures, but the effectiveness and indications for each approach remain debated, highlighting the need for further research to establish a standardized treatment protocol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress of treatment of cubital tunnel syndrome]. Yu, S., Liu, S., Fan, C.[2018]

A review of nine randomized controlled trials involving 527 participants found that percutaneous electrical nerve stimulation (PENS) showed a statistically significant but clinically insignificant reduction in musculoskeletal pain compared to transcutaneous electrical nerve stimulation (TENS).

When focusing on studies with a lower risk of bias, there was no significant difference in pain reduction between PENS and TENS, indicating that both methods may be equally effective for managing pain intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Versus Transcutaneous Electrical Nerve Stimulation for the Treatment of Musculoskeletal Pain. A Systematic Review and Meta-Analysis. Beltran-Alacreu, H., Serrano-Muñoz, D., Martín-Caro Álvarez, D., et al.[2022]

A systematic review of 19 randomized controlled trials (RCTs) on transcutaneous electrical nerve stimulation (TENS) for chronic pain found that while active TENS showed positive analgesic outcomes in 10 out of 15 studies compared to inactive controls, the overall evidence is inconclusive due to poor methodological quality and variability in study designs.

The review highlighted a lack of clarity on the optimal stimulation parameters for TENS and emphasized the need for larger, well-designed multi-centre trials to better assess the long-term effectiveness of TENS in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Carroll, D., Moore, RA., McQuay, HJ., et al.[2018]

In a pilot study involving 20 patients with cancer pain, transcutaneous electrical nerve stimulation (TENS) was found to be safe, with 85% of patients using intensity-modulated TENS (IMT) reporting at least slight pain improvement compared to 50% with placebo TENS (PBT).

However, the overall change in average pain intensity did not significantly differ between IMT and PBT, suggesting that while TENS may be desired by patients, it may not provide greater analgesic effects than placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial. Siemens, W., Boehlke, C., Bennett, MI., et al.[2021]

References

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

Cubital tunnel syndrome. [2017]

2. China pubmed.ncbi.nlm.nih.gov

[Progress of treatment of cubital tunnel syndrome]. [2018]

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

Functional Outcomes of Cubital Tunnel Release in Patients with Negative Electrodiagnostic Studies. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[Cubital tunnel syndrome : Diagnostics and therapy]. [2018]

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

Postsurgical Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial. [2020]

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

Percutaneous Versus Transcutaneous Electrical Nerve Stimulation for the Treatment of Musculoskeletal Pain. A Systematic Review and Meta-Analysis. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Immediate effects of TENS and HVPS on pain and range of motion in subacromial pain syndrome: A randomized, placebo-controlled, crossover trial. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. [2018]

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

The effect on handgrip strength of low-frequency percutaneous electric stimulation applied to the median and cubital nerves: A randomized, double-blind controlled trial. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial. [2021]

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

Trends in the Surgical Treatment for Cubital Tunnel Syndrome: A Survey of Members of the American Society for Surgery of the Hand. [2019]