Abstract
ObjectivePain is the principal symptom in knee osteoarthritis (OA). Current non-operative treatment options have only moderate effects and often patients experience persistent pain or side-effects. Novel advances in the field of cryoneurolysis applies low temperatures to disrupt nerve signaling at the painful area, providing pain relief. The primary aim of this randomized controlled trial (RCT) is to investigate if cryoneurolysis is superior to sham at decreasing pain intensity 2 weeks after the intervention in patients with knee OA. Secondary aims are to explore effects on pain, quality of life and functional performance over 24 months.MethodsThis two-arm, parallel-group RCT, approved by the Regional Ethics Committee, will randomly allocate patients (n = 94) to a cryoneurolysis intervention group + standardized education and exercise (CRYO) or a sham group + standardized education and exercise (SHAM) (1:1 ratio). Both groups will be assessed at baseline, 2 weeks post intervention, post education and exercise and at 6, 12 and 24 months after cryoneurolysis. The primary outcome is the NRS knee pain intensity score assessed 2 weeks post the intervention. Secondary outcome measures include functional performance (chair-stand test, 40 m walk, stair test and maximum voluntary contraction of the knee), patient reported outcomes (quality of life (EQ5D), Knee and osteoarthritis outcome scores (KOOS), among others), use of analgesics, and adverse events over 24 months.Impact statementCryoneurolysis could potentially provide an effective, safe and non-pharmacological therapeutic option to treat pain in OA patients. The potential benefits include increased functional capacity and quality of life as a result of significant pain relief and improved benefits of physical exercise.Trial registrationClinicaltrials.gov, NCT03774121, registered 3 March 2018, http://www.clinicaltrials.gov
Highlights
Chronic pain represents a major challenge worldwide, with significant clinical, social and economic implications
Dasa et al introduced preoperative cryoneurolysis to the infrapatellar branch of the saphenous nerve (ISN) and the anterior femoral cutaneous nerve (AFCN) prior to total knee arthroplasty (TKA) in patients with knee OA and observed a statistically significant reduction in hospital stay, and a decrease in prescribed opioids [27]. These results provide clinical evidence, suggesting that cryoneurolysis treatment is a safe procedure, that may reduce both pain and symptoms in patients with knee OA [14, 28]
The primary objective of this randomized controlled trial (RCT) is to investigate if cryoneurolysis is superior to sham at decreasing pain intensity 2 weeks after the intervention in patients with painful knee OA
Summary
If patients experience a ≥ 50% decrease in knee pain intensity (NRS) as a result of the nerve block, they will be randomly allocated to either a cryoneurolysis intervention group (CRYO) or a sham group (SHAM). All patients reporting a decrease of ≥50% in NRS pain scores are scheduled for a second visit for cryoneurolysis. Second visit Ropivacain (5 mg/ml) is injected before treatment, locally at the insertion-point, 4-6 cm from target nerve locations This allows for continuous patient feedback during the following procedures. Primary outcome The primary outcome is the change in patient reported knee pain intensity assessed using the numeric rating scale (NRS) from baseline to 2 weeks post cryoneurolysis compared between group CRYO and SHAM. The sham group is implemented according to current standards [50]
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