Treatment for Neuroma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Curtis National Hand Center at Medstar Union Memorial Hospital, Baltimore, MD
Neuroma
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a surgery which stimulates nerves can help treat neuromas in the hand and fingers.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 6 primary outcomes and 13 secondary outcomes in patients with Neuroma. Measurement will happen over the course of Assessing change from Baseline to 1 month, 3 months and 6 months.

Month 6
Fine Motor Function - 9-Hole Peg Test (9HPT)
Functional Task Testing - Carrying Boxes
Functional Task Testing - Gear Shifting
Functional Task Testing - Hammer
Functional Task Testing - Push/Pull sled
Functional Task Testing - Vice Grip
Functional Task Testing - Weapon Recoil
FunctionalTask Testing - Lifting boxes
Grip Strength
Pinch Strength -Key and Three-point
Range of Motion
Month 6
Brief Michigan Hand Outcomes Questionnaire (bMHQ)
Generalized Anxiety Disorder measure (GAD-7)
PC-PTSD-5
PROMIS Global Health (GH) v1.2
PROMIS UpperExtremity (UE)
Patient Health Questionnaire (PHQ-9)
Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI)
Short-form McGill Pain Questionnaire (SF-MPQ-2)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Traction Neurectomy
1 of 2
Regenerative Peripheral Nerve Interface
1 of 2
Active Control

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Traction Neurectomy
Procedure
simple excision and traction neurectomy
Regenerative Peripheral Nerve Interface
Procedure
symptomatic neuroma is excised, and the end of the peripheral nerve is implanted into a small denervated free muscle graft harvested from the patient

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessing change from baseline to 1 week, 1 month, 3 months and 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly assessing change from baseline to 1 week, 1 month, 3 months and 6 months for reporting.

Closest Location

The Curtis National Hand Center at Medstar Union Memorial Hospital - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You must be at least 18 years old to gamble show original
I would suggest seeing a hand therapist to try a desensitization therapy program show original
The history of unilateral digit amputation or amputation of multiple digits, or amputation of a part of the hand, can be traced back to the early 1800s show original
The doctor found a discrete neuroma on clinical exam which was causing my pain. show original
After following the SOC, if the injury is still suspected, a local block and/or ultrasound imaging will be performed. show original

Patient Q&A Section

Does treatment improve quality of life for those with neuroma?

"While this large, multicenter study demonstrated that surgery improved pain and disability but not QOL, treatment is still indicated for most patients. Further studies should examine the role of surgical interventions and therapies to improve patient QOL." - Anonymous Online Contributor

Unverified Answer

Has treatment proven to be more effective than a placebo?

"We found no difference in pain relief between the two groups after 24 weeks (p>0.05). Based on our data, we believe that there is insufficient evidence for the use of anti-inflammatory injections in the management of chronic neuropathic pain in adults." - Anonymous Online Contributor

Unverified Answer

What is the latest research for neuroma?

"This article presents the latest scientific information on the prevention and treatment of chronic pain from peripheral nerve entrapment neuropathies. The latest evidence suggests that specific exercise regimens and lifestyle changes help to prevent neuromas. However, the best treatment regimen remains unknown. Patients should be informed about their options and asked if they wish to take part in clinical trials evaluating new treatments." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"The most commonly reported side effects were headache (13%) and dizziness (12%). Most patients who reported these side effects also said that they were not related to their treatment." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving treatment?

"Data from a recent study of this study suggest that there was no difference in the recurrence rate between the two groups. Data from a recent study does not show any significant differences in survival rates, nor does it support the hypothesis that prophylactic stenting reduces early complication rates." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for neuroma?

"The 5-year survival rate for neuroma is high as compared to other soft tissue tumors. There was no relationship between the size of the lesion and the 5-year survival rate. Survival rates were higher among women and those who had complete excision of the primary tumor at presentation. In contrast to our previous study (followup period 4 years), the 5-year survival rate for neuroma was not significantly different." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets neuroma?

"The median age at diagnosis is 58 years. In the United States, estimates vary widely between younger populations such as those living in Northern Europe and older ones like Japan. Neuroma occurs more often in women than men. Neurologists should be aware that neuroma can occur in children.\n" - Anonymous Online Contributor

Unverified Answer

How serious can neuroma be?

"The medical literature reveals a wide range of severity, from mild discomfort to severe pain. (https://www.nhs.uk/health/keytopics/[neuropathy](https://www.withpower.com/clinical-trials/neuropathy)/pages/neuropathy.aspx). We discuss what these ranges of severity mean in terms of the impact on quality of life. (https://www.nhs.uk/health/keytopics/neuropathy/pages/neuropathy.aspx). It is important that people know that the extent of their neuropathy does not necessarily reflect its severity. This is especially true in cases where there has been prolonged compression of the nerve root without release of pressure, which would account for the pain experienced." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"The present study suggests that the best treatment for patients with chronic pain following peripheral nerve injury is a multidisciplinary approach involving physical therapists, psychologists, occupational therapists, social workers, and psychiatrists. These specialists should work together to provide appropriate interventions for each patient based on their needs." - Anonymous Online Contributor

Unverified Answer

Does neuroma run in families?

"Neurofibromas were more prevalent in families with neurofibromatosis type 1 (NF1) than in families without NF1. This suggests that genetic predisposition may play a role in the development of this tumor. The implication of these findings is that all patients with neurofibroms should be screened for this disorder." - Anonymous Online Contributor

Unverified Answer

How many people get neuroma a year in the United States?

"The prevalence of neuroma was 0.5% (95% CI: 0.4% to 0.6%) in this population-based sample. Neuroma occurred at least as often in women as in men. It is important for physicians to be aware of the possible progression of neuromas and use the latest imaging techniques when examining patients with symptoms suggestive of peripheral nerve disease." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Neuroma by sharing your contact details with the study coordinator.