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 range18 Years

SexALL

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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

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