Percutaneous Image-Guided Cryoablation for the Treatment of Phantom Limb Pain in Amputees: A Pilot Study

Abstract

Purpose To prospectively evaluate percutaneous image-guided nerve cryoablation for treatment of refractory phantom limb pain (PLP) in a pilot cohort for purposes of deriving parameters to design a larger, randomized, parallel-armed, controlled trial. Materials and Methods From January 2015 to January 2016, 21 patients with refractory PLP underwent image-guided percutaneous cryoneurolysis procedures. Visual analog scale scores were documented at baseline and 7, 45, and 180 days after the procedure. Responses to a modified Roland Morris Disability Questionnaire were documented at baseline and 7 and 45 days after the procedure. Results Technical success rate of the procedures was 100%. There were 6 (29%) minor procedure-related complications. Disability scores decreased from a baseline mean of 11.3 to 3.3 at 45-day follow-up (95% confidence interval 5.8, 10.3; P < .0001). Pain intensity scores decreased from a baseline mean of 6.2 to 2.0 at long-term follow-up (95% confidence interval 2.8, 5.6; P < .0001). Conclusions Image-guided percutaneous nerve cryoablation is feasible and safe and may represent a new efficacious therapeutic option for patients with phantom pains related to limb loss.

Phantom limb pain: peripheral neuromodulatory and neuroprosthetic approaches to treatment

“…Cryoablation involves the application of cold to nerves, creating a conduction block that can be retained chronically by inducing Wallerian degeneration of the nerve . This percutaneous, image‐guided surgery can be performed using minimally invasive techniques, and produced a 66% reduction in phantom pain up to 300 days in one study . Concomitant nerve coaptation and collagen nerve wrapping have been described to be effective as well in preventing painful neuromas and PLP after transfemoral amputation .…”

Principles of Designing a Clinical Trial: Optimizing Chances of Trial Success

“…These trials found promising effects of neuromodulation to alleviate PLP (low risk approach with high potential benefits). Other pilot studies concerned the application of sympathetic blocks (24) and cryoablation (12) for the treatment of PLP. In order to translate these techniques to clinical practice, the next step would be to conduct a pivotal trial.…”

“…We chose PLP given our experience designing trials for it as well as other neuropathic pain syndromes. Furthermore, PLP clinical trials have tested a variety of interventions including drugs (7,8), non-invasive brain stimulation (NIBS) (9–11), and invasive procedures (12). In addition, PLP is a disorder whose pathophysiology and optimum management remain elusive despite numerous studies.…”

Interventional Cryoneurolysis: What Is the Same, What Is Different, What Is New?

“…As examples, the use of CT guidance for percutaneous cryoneurolysis in amputees has been reported for the management of phantom limb pain. 25 Fritz and coworkers have described MRI-guided cryoneurolysis of the sural nerve and posterior femoral cutaneous nerves to manage pain. 26,27 Kim and Ferrante reported using image guidance to cryoablate the obturator nerve for treatment of adductor spasticity.…”