Surgery vs Nonsurgical Treatment for Cubital Tunnel Syndrome

Not yet recruiting at 6 trial locations
JR
MP
Overseen ByMichael P Chen, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether early surgery or using an elbow night splint is more effective for individuals with mild-to-moderate cubital tunnel syndrome. This condition occurs when the ulnar nerve near the elbow becomes compressed, leading to pain, numbness, or weakness in the arm and hand. Participants will be randomly assigned to undergo surgery (cubital tunnel release) or use a night splint to evaluate which option improves symptoms and function over time. Individuals who have experienced cubital tunnel syndrome symptoms for at least six weeks and can adhere to the study's schedule may be suitable candidates. As an unphased trial, this study provides a unique opportunity to enhance understanding of effective treatments for cubital tunnel syndrome.

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

Research has shown that cubital tunnel release surgery is generally safe and well-tolerated. Studies indicate that 87% to 94% of patients experience improvement after the surgery. The procedure carries a low risk of complications, with only about 3.8% of patients encountering issues, such as minor nerve problems in rare cases. Recovery typically takes about three months, and many patients resume normal activities within this period. Overall, this surgery significantly benefits most people with cubital tunnel syndrome.12345

Why are researchers excited about this trial?

Researchers are excited about the investigation into the surgical and conservative treatments for cubital tunnel syndrome because they offer different approaches to managing this condition. Unlike standard care, which often involves a combination of rest, splinting, and anti-inflammatory medications, the surgical treatment aims to relieve pressure on the ulnar nerve through a procedure called cubital tunnel release. This could provide more immediate relief by directly addressing the nerve compression. On the other hand, the conservative treatment offers a non-invasive option that manages symptoms while still allowing for a potential switch to surgery if needed. This dual approach allows for flexibility in treatment, potentially leading to tailored patient care and improved outcomes.

What evidence suggests that this trial's treatments could be effective for cubital tunnel syndrome?

This trial will compare surgical and nonsurgical treatments for cubital tunnel syndrome. Research has shown that cubital tunnel release surgery, which participants in the surgical arm of this trial may receive, often greatly improves symptoms. In one study, patients reported their pain levels dropping from 8.5 to 1.7, and their grip strength improving from 41% to 86% of the unaffected side after surgery. Another study found that 60% of patients experienced complete relief from symptoms after the procedure. Complications are uncommon, with only 3.8% of patients experiencing issues like ulnar nerve instability. Overall, surgery has proven effective for many people dealing with the discomfort of this condition.678910

Who Is on the Research Team?

JR

John R Fowler, MD

Principal Investigator

University of Pittsburgh Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with mild-to-moderate cubital tunnel syndrome, which causes numbness, tingling, or weakness in the hand and arm due to pressure on a nerve at the elbow. Participants must not have severe symptoms or other major health issues affecting their arms.

Inclusion Criteria

Able to provide written informed consent
I am 18 years old or older.
Willing and able to comply with follow-up schedule, study procedures, and splinting protocol if randomized to conservative management
See 3 more

Exclusion Criteria

Concurrent participation in another interventional study affecting upper extremity function
I have nerve problems that could affect test results.
Pregnancy
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either surgical intervention or conservative management with an elbow night splint

6 months
Visits at baseline, 6 weeks, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of nerve function and patient-reported outcomes

18 months
Visits at 1 year and 2 years

Extension

Participants may continue to be monitored for long-term outcomes and any surgical conversions

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Conservative Arm
  • Cubital tunnel release

Trial Overview

The study compares two treatments: early surgery (cubital tunnel release) versus wearing an elbow night splint. Participants are randomly assigned to one of these groups and followed for up to two years with exams and questionnaires.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: SurgicalExperimental Treatment1 Intervention
Group II: ConservativeActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

Citations

Prospective Comparison of Techniques for Cubital Tunnel ...

Patients undergoing cubital tunnel release surgery ... Outcomes following modified oblique medial epicondylectomy for treatment of cubital tunnel syndrome.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28258868/

Rates of Complications and Secondary Surgeries After In ...

Results: In 157 in situ cubital tunnel releases, there were 6 complications (3.8%), including 3 cases (1.9%) of ulnar nerve instability, 2 cases (1.3%) of ...

Cubital Tunnel Surgery | Peripheral Nerve Center

Surgical treatment of cubital tunnel syndrome consists of one or more procedures depending on the patient and the specific cause of the nerve irritation:.

Preliminary Results of Recurrent Cubital Tunnel Syndrome ...

A significant improvement was demonstrated in postoperative pain levels (from 8.5 to 1.7), grip strength (from 41% to 86% of the unaffected side), and pinch ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36728488/

Functional Outcomes of Cubital Tunnel Release in Patients ...

Results: At a mean follow-up period of 20.7 ± 14.9 months, 15 of 25 cases (60.0%) had complete resolution of all preoperative symptoms. All 10 ...

Safety and Outcomes of Different Surgical Techniques for ...

87% of patients improve with surgery. During surveillance, 3% (95% CI, 1%-4%) of patients developed recurrence, and open in situ decompression ...

Safety and Outcomes of Different Surgical Techniques for ...

87% of patients improve with surgery. During surveillance, 3% (95% CI, 1%-4%) of patients developed recurrence, and open in situ decompression ...

Modern Treatment of Cubital Tunnel Syndrome: Evidence ...

cubital tunnel release provided considerable relief in 94% of patients, even though EDX reports showed that only 11% of patients had clear CuTS, 23% had ulnar ...

Cubital Tunnel Release - OrthoInfo - AAOS

Many surgeons caution their patients that it can take 12 to 18 months after surgery to see the final results. Overall, long-term outcomes of cubital tunnel ...

Rates of Complications and Secondary Surgeries After In ...

147 patients underwent 157 situ cubital tunnel releases, there were 6 complications (3.8%), including 3 cases (1.9%) of ulnar nerve instability, 2 cases