Dataset Information

Cryoneurolysis for the management of chronic pain in patients with knee osteoarthritis; a double-blinded randomized controlled sham trial.

ABSTRACT:

Objective

Pain 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.

Methods

This 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 statement

Cryoneurolysis 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 registration

Clinicaltrials.gov, NCT03774121 , registered 3 March 2018, http://www.clinicaltrials.gov.

SUBMITTER: Nygaard NB

PROVIDER: S-EPMC7913284 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Cryoneurolysis for the management of chronic pain in patients with knee osteoarthritis; a double-blinded randomized controlled sham trial.

Nygaard Niels-Peter Brøchner NB Koch-Jensen Carsten C Vægter Henrik Bjarke HB Wedderkopp Niels N Blichfeldt-Eckhardt Morten M Gram Bibi B

BMC musculoskeletal disorders 20210226 1

<h4>Objective</h4>Pain 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 ...[more]

PMID: 33637085

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Dataset Information

Cryoneurolysis for the management of chronic pain in patients with knee osteoarthritis; a double-blinded randomized controlled sham trial.

Objective

Methods

Impact statement

Trial registration

Publications

Cryoneurolysis for the management of chronic pain in patients with knee osteoarthritis; a double-blinded randomized controlled sham trial.

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