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Published on: September 13, 2015
Measuring the Efficacy of Percutaneous Cryoneurolysis in Participants With Refractory or Plateaued Shoulder, Elbow,
Mahdis Hashemi, Fraser MacRae, Ève Boissonnault
1Pacira BioSciences, Inc., Tampa, FL, USA.
Objective:
The aim of the study was to investigate novel, minimally invasive cryoneurolysis for refractory or plateaued upper limb spasticity.
Design:
This was a repeated-measures, single-center, observational pilot study (NCT04670783). Percutaneous cryoneurolysis was applied to the upper limb nerves and intramuscular branches of 59 adults with upper limb spasticity refractory to or plateaued on botulinum therapies. Maximal passive range of motion (V1), active ROM, and modified Ashworth scale score were measured during shoulder flexion, abduction, and external rotation and elbow and wrist extension at baseline and follow-up to 1 yr. Additional outcomes included pain, participant satisfaction, and upper limb disability.
Results:
Overall, 59 participants received cryoneurolysis in ≥1 region targeting nerves that innervate muscles supporting shoulder ( n = 47), elbow ( n = 33), wrist ( n = 18), and fingers/thumb ( n = 29) movement. At 12 mos, there was significant change from baseline in V1, active ROM, and modified Ashworth scale score for shoulder flexion and abduction and in V1 and modified Ashworth scale score for external rotation. Similar results were observed for elbow extension V1, active ROM, and modified Ashworth scale score and wrist extension modified Ashworth scale score. Average daily pain, participant satisfaction, and upper limb disability improved.
Conclusions:
Participants with plateaued or refractory spasticity had improvements in upper limb regions; future evaluations of cryoneurolysis treatment for spasticity are warranted.
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