TerminatedPhase 4

Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain

Stopped: Principal investigator is leaving the university.

United States1 participantsStarted 2021-09-01

Plain-language summary

Participants with chronic, refractory phantom limb pain (PLP) or residual limb pain (RLP) for more than 6 months will be enrolled in this clinical trial. Aim: Define the attributable pain relief and functional improvement in participants with PLP/RLP after contralateral limb sciatic nerve block. Also, contribute to the basic science understanding of the crossed-withdraw reflex by demonstrating a known animal model phenomenon in human participants. Hypothesis: Contralateral limb sciatic nerve anesthetic block with 2% lidocaine provides immediate clinically meaningful pain reduction, defined as the proportion of patients with at least 50% improvement in numeric rating scale (NRS) pain score in PLP/RLP when compared to sham.

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: * 1\. Age greater than 18 years of age at day of enrollment * 2\. Lower extremity amputation performed more than 12 months before study enrollment * 3\. PLP/RLP in affected amputated limb \> 4 on numeric rating scale 26 (NRS26) * 4\. Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis) * 5\. Willingness to undergo image guided diagnostic nerve block Exclusion Criteria: * 1\. Refusal / inability to participate or provide consent * 2\. Contraindications to diagnostic nerve block * 3\. Non-neurogenic source of PLP/RLP * 4\. Current opioid use \> 50 morphine milligram equivalents per day * 5\. Any interventional pain treatment in the residual limb within the last 30 days * 6\. Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism) * 7\. Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment

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

Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score

Timeframe: 15 minutes after treatment

Trial details

NCT IDNCT05046639

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-26

Results submitted2023-07-30

View on ClinicalTrials.gov More Pain trials