Ultrasound-guided Percutaneous Cryoneurolysis to Treat Chronic Postamputation Phantom Limb Pain: A Multicenter Randomized Controlled Trial

Author:

Ilfeld Brian M.1ORCID,Smith Cameron R.2,Turan Alparslan3,Mariano Edward R.4,Miller Matthew E.5,Fisher Rick L.6,Trescot Andrea M.7,Cohen Steven P.8,Eisenach James C.9,Sessler Daniel I.10,Prologo J. David11,Mascha Edward J.12,Liu Liu13ORCID,Gabriel Rodney A.14,

Affiliation:

1. 1Department of Anesthesiology‚ University of California San Diego‚ San Diego‚ California.

2. 2Department of Anesthesiology‚ University of Florida‚ Gainesville‚ Florida.

3. 3Departments of General Anesthesia and Outcomes Research‚ Cleveland Clinic‚ Cleveland‚ Ohio.

4. 4Department of Anesthesiology, Perioperative and Pain Medicine‚ Palo Alto Veterans Affairs‚ Palo Alto‚ California.

5. 5Department of Anesthesiology‚ Walter Reed National Military Medical Center‚ Bethesda‚ Maryland.

6. 6Department of Anesthesiology‚ Naval Medical Center San Diego‚ San Diego‚ California.

7. 7Florida Pain Relief Group‚ Tampa‚ Florida.

8. 8Department of Anesthesiology‚ Johns Hopkins‚ Baltimore‚ Maryland.

9. 9Department of Anesthesiology‚ Wake Forest School of Medicine‚ Winston-Salem‚ North Carolina.

10. 10Department of Outcomes Research‚ Cleveland Clinic‚ Cleveland‚ Ohio.

11. 11Department of Radiology‚ Emory University‚ Atlanta‚ Georgia.

12. 12Departments of Quantitative Health Sciences and Outcomes Research‚ Cleveland Clinic‚ Cleveland‚ Ohio.

13. 13Departments of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic, Cleveland, Ohio.

14. 14Department of Anesthesiology‚ University of California San Diego‚ San Diego‚ California.

Abstract

Background Postamputation phantom pain is notoriously persistent with few validated treatments. Cryoneurolysis involves the application of low temperatures to reversibly ablate peripheral nerves. The authors tested the hypothesis that a single cryoneurolysis treatment would decrease phantom pain 4 months later. Methods The authors enrolled patients with a lower-limb amputation and established phantom pain. Each received a single-injection femoral and sciatic nerve block with lidocaine and was subsequently randomized to receive either ultrasound-guided percutaneous cryoneurolysis or sham treatment at these same locations. The primary outcome was the change in average phantom pain intensity between baseline and 4 months as measured with a numeric rating scale (0 to 10), after which an optional crossover treatment was offered. Investigators, participants, and clinical staff were masked to treatment group assignment with the exception of the treating physician performing the cryoneurolysis, who had no subsequent participant interaction. Results Pretreatment phantom pain scores were similar in both groups, with a median [quartiles] of 5.0 [4.0, 6.0] for active treatment and 5.0 [4.0, 7.0] for sham. After 4 months, pain intensity decreased by 0.5 [–0.5, 3.0] in patients given cryoneurolysis (n = 71) versus 0 [0, 3] in patients given sham (n = 73), with an estimated difference (95% CI) of –0.1 (–1.0 to 0.7), P = 0.759. Following their statistical gatekeeping protocol, the authors did not make inferences or draw conclusions on secondary endpoints. One serious adverse event occurred after a protocol deviation in which a femoral nerve cryolesion was induced just below the inguinal ligament—instead of the sensory-only saphenous nerve—which resulted in quadriceps weakness, and possibly a fall and clavicle fracture. Conclusions Percutaneous cryoneurolysis did not decrease chronic lower extremity phantom limb pain 4 months after treatment. However, these results were based upon the authors’ specific study protocol, and since the optimal cryoneurolysis treatment parameters such as freeze duration and anatomic treatment location remain unknown, further research is warranted. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Anesthesiology and Pain Medicine

Reference39 articles.

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2. Postamputation pain: Epidemiology, mechanisms, and treatment.;Hsu;J Pain Res,2013

3. Phantom pain and sensation among British veteran amputees.;Wartan;Br J Anaesth,1997

4. A review of the management of phantom limb pain: Challenges and solutions.;Richardson;J Pain Res,2017

5. Phantom-limb pain as a perceptual correlate of cortical reorganization following arm amputation.;Flor;Nature,1995

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