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MedStar Health Research Institute is enrolling patients with post-amputtion pain in the hands or fingers in a clinical study of an exciting new technique called regenerative peripheral nerve interface.
Each year in the U.S., over 61,000 amputations of a portion of the hand occur, involving the loss of at least one finger. As many as 30% of patients with hand and finger amputations develop painful neuromas—balls of nerves and scar tissue that form when a damaged nerve can’t “close the loop” and attach to healthy nerve tissue to heal.
Traction neurectomy, the standard of care for symptomatic neuromas, does not prevent neuroma recurrence and has inconsistent results for pain relief. Patients often are told (or assume) there are no further options, leading many to suffer in silence, sometimes for decades.
But a novel procedure— regenerative peripheral nerve interface (RPNI)—in clinical trials at MedStar Health’s Curtis National Hand Center is showing promise for lasting, effective neuroma pain relief. RPNI involves grafting a small portion of the patient’s muscle onto the injured nerve, giving it a “target” to latch onto and avoiding new or recurrent neuromas. Though RPNI does not restore normal sensation, it essentially numbs the pain, providing significant relief.
MedStar Health Research Institute is enrolling patients with post-amputation hand and finger neuromas in a clinical study, sponsored by the U.S. Department of Defense, to assess both the physical and mental health outcomes of successful treatment with RPNI.
Neuromas can be physically and emotionally devastating, causing hypersensitivity to normal stimuli or sharp, shocking pain when the skin is touched anywhere near the neuroma. This debilitating nerve pain can cause patients to feel sickening, gnawing sensations or burning, raw, or stabbing pains when performing activities as simple as shaking hands or tying their shoes—let alone working, exercising, or enjoying hobbies.
Nerve symptoms pile onto the trauma of the injury that resulted in amputation, such as an accident at work or in the line of duty. As a result, patients often suffer even more impactful reduction in quality of life, including mental health consequences such as anxiety, depression, and post-traumatic stress disorder (PTSD).
A study published in 2020 reviewed the results of 30 RPNI procedures performed from 2014 to 2019. At an average follow up of 37 weeks, 85% of patients were pain-free or considerably improved.
In our study, researchers here and at the University of Michigan—where RPNI was developed—will gather data to determine whether RPNI is effective in helping relieve hand and finger amputation patients’ pain and allow them to regain sufficient function to return to work or military service.
For patients who have suffered trauma and amputation, the success we’ve seen so far with RPNI offers hope for lasting relief from debilitating neuroma pain.
Neuromas and the results of chronic pain.
For many patients, hand trauma can be a strong predictor of prolonged pain, disability, and opioid use. A 2019 study of 328 patients who had undergone amputation showed that 20% developed persistent post-operative opioid use. Successful neuroma surgery can reduce opioid use.
Approximately 30% of people with amputations have depression, which likely is underreported. Other mental health challenges can include decreased self-esteem, distorted body image, increased dependency, and social isolation. The ongoing stress from pain can lead to physiologic changes, such as increased blood pressure and heart rate variability.
Military service is among the most common sources of traumatic injury that leads to amputation of the fingers or hand. Researchers have learned that PTSD appears to be more common in people with amputations after combat, accidental injury, burns, and suicide attempts.
However, RPNI surgery can provide significant physical and mental pain relief for many patients. One of the goals of our study is to determine the extent to which RPNI also can alleviate emotional and behavioral health symptoms.
Researching surgery to alleviate neuroma symptoms.
Our study is currently enrolling up to 80 participants who are age 18 or older and have neuroma pain in one or more amputated fingers or some or all of their hand. Patients who have previously had neuroma surgery or who have other major injuries causing chronic pain are not eligible for this trial.
Patients at MedStar Health’s Curtis National Hand Center and at the University of Michigan will be followed for six months after surgery. Each participant will complete an electronic questionnaire before surgery to assess their overall health, physical pain, and mental health. Their medications and dosages will be logged. Prior to surgery, patients’ blood pressure, heart rate, and heart rate variability will all be monitored to establish a baseline for comparison.
Patients will be randomly selected for either RPNI surgery or resection and traction neurectomy (the current standard of care). All patients will receive the same postoperative care, including questionnaires and checkups at one week, one month, three months, and six months after surgery.
At three and six months after surgery, we will evaluate how well patients can perform specific functional tasks such as carrying boxes, hammering, and pushing and pulling a sled. Investigators are focusing on physical (strength and motion), physiologic (blood pressure and heart rate variability), and mental (depression, PTSD) health outcomes throughout the study.
Preliminary and anecdotal data indicate that RPNI may have the potential to significantly improve patients’ outcomes. For instance, I’ve treated a patient with very painful neuromas that left them unable to shake hands or operate equipment at work. The pain was so severe that the patient was afraid of even lightly touching their hand. They experienced recurring nightmares about their injury and lived with depression for several years.
RPNI surgery provided so much relief that it essentially gave my patient a new lease on life—and they are not feeling depressed for the first time in years.
With this study, our goal is to help more patients living with neuroma pain get effective treatment to regain function, return to work, reduce their use of pain medications, and access more successful cognitive and behavioral therapy to improve their mental health.
There is hope for relief.
Many hand surgeons are still learning about RPNI, and our study aims to provide rigorous, scientific evidence that this simple procedure is safe and effective.
The inability to return to work or duty is often cited as a substantial factor in patients’ mental health concerns. With the pain reduction offered by RPNI, we believe many patients will be able to return to work, providing stability and potentially improving self-worth.
We’re excited about the promise of RPNI surgery and believe it can make a major difference for workers, military members, and others who suffer from the debilitating effects of neuromas.
