CompletedNot Applicable

Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

United States16 participantsStarted 2017-12-01

Plain-language summary

Limb loss is frequently associated with postamputation pain that can be challenging to treat and often involves opioids. Advances in the field of neuromodulation has led to development of an intentionally reversible percutaneous peripheral nerve stimulation (PNS) system that has had promising results when treating chronic postamputation pain. PNS may offer sustained pain relief even after the treatment period has ended. Currently, there is no convincing evidence regarding the role of PNS in the acute postoperative period, which may be a critical time to control pain as those with higher pain appear to be at higher risk for developing persistent post-procedural pain. The investigators of this study aim to evaluate the feasibility and effects of PNS in the acute postoperative period and determine the feasibility of completing a randomized controlled treatment outcome study.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Nontraumatic transfemoral (above-the-knee) or transtibial (below-the-knee) amputation * Presence of postamputation pain rated at least 4 or more Exclusion Criteria: * Beck Depression Inventory score greater than 20 * Systemic infection * Immunocompromised or taking immunosuppressive medications * Implanted electronic device * Pregnancy * Previous allergy to skin contact materials and/or anesthetic agent * Altered mental status * Inability to provide informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average Phantom Limb Pain (PLP) Score

Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3.

Average Residual Limb Pain (RLP) Score

Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3

Worst Phantom Limb Pain (PLP) Score

Timeframe: Baseline, Weeks 1-4, 5-8, and Month 3

Worst Residual Limb Pain (RLP) Score

Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3

Best Phantom Limb Pain (PLP) Score

Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3

Best Residual Limb Pain (RLP) Score

Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3

Trial details

NCT IDNCT03484429

SponsorHunter Holmes Mcguire Veteran Affairs Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2021-04-17

Results submitted2021-04-13

View on ClinicalTrials.gov More Phantom Limb Pain trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Average Phantom Limb Pain (PLP) Score

Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3.

Average Residual Limb Pain (RLP) Score

Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3

Worst Phantom Limb Pain (PLP) Score

Timeframe: Baseline, Weeks 1-4, 5-8, and Month 3

Worst Residual Limb Pain (RLP) Score

Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3

Best Phantom Limb Pain (PLP) Score

Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3

Best Residual Limb Pain (RLP) Score

Timeframe: Baseline, Weeks 1-4, Weeks 5-8, and Month 3