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Surgical Treatments for Neuroma Pain (STOCAP Trial)

N/A

Waitlist Available

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.

Must not have

Patient unable to sign informed consent

Age < 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year post-operatively

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give my consent for treatment.

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I am under 18 years old.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Worst reported phantom limb pain score on a numerical scale

Worst reported residual limb pain score on a numerical scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met