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Surgical Treatments for Neuroma Pain (STOCAP Trial)

N/A

Recruiting

Led By Sami Tuffaha, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Patients presenting with > 6 months of intractable post-amputation limb pain with no history of previous surgical intervention for pain treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year post-operatively

Awards & highlights

STOCAP Trial Summary

This trial is testing a new surgical treatment for amputees with symptomatic neuromas (nerve tumors that cause pain and disability). The new treatment is compared to two other contemporary surgical approaches, with the goal of finding which is most effective.

Who is the study for?

This trial is for adults over 18 with chronic pain after limb amputation, who haven't had previous surgery for pain relief. They must be able to consent and participate in all tests. Women of childbearing age need a negative pregnancy test.Check my eligibility

What is being tested?

The study compares three surgical techniques for neuroma pain: TMR transfers injured nerves into muscle, RPNI uses muscle grafts on nerve stumps, and VDMT provides denervated muscle targets for regenerating nerves.See study design

What are the potential side effects?

Potential side effects from the surgeries may include infection, bleeding, increased pain if the procedure doesn't work as intended, numbness around the surgical site or general anesthesia risks.

STOCAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have had limb pain for over 6 months after amputation without any pain surgery.

STOCAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Worst reported phantom limb pain score on a numerical scale

Worst reported residual limb pain score on a numerical scale

STOCAP Trial Design

3Treatment groups

Active Control

Group I: Regenerative peripheral nerve interface (RPNI)Active Control1 Intervention

In this operation, the surgeon will make a skin incision and carefully identify nerves that were likely to have been injured during the amputation surgery. The nerves are then "cleaned up" to enhance the possibility of healthy healing. Then the surgeon takes a small sample from a muscle (usually one close by to the nerves that are being operated on but sometimes through a second incision in the arm or leg, depending on the exact medical situation) and form something called a "muscle graft". The muscle graft is used to wrap the cleaned ends of the nerves mentioned above. This is thought to be helpful in directing the nerve healing process and reducing the risk of developing pain in the future. This operation takes 1 - 3 hours and occurs in the hospital. Follow up requires six to seven clinic visits with the surgeon over the course of one year, at which time standard questionnaires will be used to assess pain.

Group II: Vascularized, denervated muscle target (VDMT )Active Control1 Intervention

In this operation, the surgeon will make a skin incision and carefully identify nerves that were likely to have been injured during the amputation surgery. The nerves are then "cleaned up" to enhance the possibility of healthy healing. The surgeon will then identify a local muscle along with a small artery and vein that supply blood to part of the muscle. A small sample of muscle, still attached to the artery and vein, is then created. The nearby nerves are then nestled into this segment of muscle that is still connected to the artery and vein. This is thought to be helpful in directing the nerve healing process and reducing the risk of developing pain in the future. This operation takes 2 - 4 hours and occurs in the hospital. Follow up requires six to seven clinic visits with the surgeon over the course of one year, at which time standard questionnaires will be used to assess pain.

Group III: Targeted Muscle Reinnervation (TMR)Active Control1 Intervention

In this operation, the surgeon will make a skin incision and carefully identify nerves that were likely to have been injured during the amputation surgery. These nerves are then "cleaned up" to be rerouted and connected to smaller nerves that control individual muscles. The connection to nerves that run into muscles is thought to be helpful in directing the nerve healing process and reducing the risk of developing pain in the future. This operation takes 2 - 4 hours and occurs in the hospital. Follow up requires six to seven clinic visits with the surgeon over the course of one year, at which time standard questionnaires will be used to assess pain.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,269 Previous Clinical Trials

14,838,552 Total Patients Enrolled

1 Trials studying Neuropathic Pain

25 Patients Enrolled for Neuropathic Pain

Sami Tuffaha, MDPrincipal InvestigatorJohns Hopkins University

1 Previous Clinical Trials

36 Total Patients Enrolled

Media Library

RPNI Clinical Trial Eligibility Overview. Trial Name: NCT04204668 — N/A

Neuropathic Pain Research Study Groups: Regenerative peripheral nerve interface (RPNI), Vascularized, denervated muscle target (VDMT ), Targeted Muscle Reinnervation (TMR)

Neuropathic Pain Clinical Trial 2023: RPNI Highlights & Side Effects. Trial Name: NCT04204668 — N/A

RPNI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04204668 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently open for the research participants?

"According to clinicaltrials.gov, this research endeavour is actively looking for volunteers. The project was initially made available on April 1st 2021 and has since been amended on April 6th 2022."

Answered by AI

How many volunteers are participating in this experiment?

"Affirmative. Per the data hosted on clinicaltrials.gov, this scientific trial is open to recruitment and was first published April 1st 2021. The most recent update took place April 6th 2022; 90 participants are being sought from two different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Surgical Treatments for Neuroma Pain in Amputees

2021. "Surgical Treatments for Neuroma Pain in Amputees". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04204668.

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