Cryoneurolysis for the Management of Chronic Pain in Patients With Knee Osteoarthritis

Summary

Pain is the principal symptom in knee osteoarthritis (OA) and results in a considerable amount of years lived with disability, emotional distress and has significant socioeconomic consequences. Conservative treatment options, such as exercise, often fail to provide long-term pain relief and alternatively patients may be subjected to total knee arthroplasty. More than 20% of these patients experience persistent and unchanged pain post-surgery. Novel advances in the field of cryoneurolysis applies low temperatures to disrupt nerve signaling at the painful area and a recent study showed that it was possible to target the peripheral nerves in the knee and provide significant pain relief in patients with knee OA. This could potentially improve the efficacy of other therapies such as exercise, delaying or perhaps avoiding surgical intervention and improving quality of life in OA patients considerably. Further prospective randomized controlled studies are needed to confirm the effects of cryoneurolysis treatment in patients with knee OA. The primary objective of the current project is to determine the effectiveness of cryoneurolysis in its ability to decrease pain in patients with knee OA. The secondary objective is to evaluate the safety and effectiveness of cryoneurolysis in its ability to improve outcomes in the GLA:D program to potentially delay or avoid surgical intervention. 90 individuals with knee OA in the knee will be randomly allocated in either a cryoneurolysis intervention group or a sham group. Both groups will be assessed at baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up. The patients, therapists and data-manager will be blinded to the allocation. The primary outcome will be VAS knee pain intensity score, measured post cryoneurolysis treatment. Secondary outcome measures include functional performance, PRO-data (KOOS, EQ5D), analgesic use, a socio-economic evaluation and adverse effects.

Conditions

• Chronic Pain
• Osteoarthritis, Knee

Interventions

DEVICE

Cryoneurolysis

A cryoprobe will be inserted percutaneously and freeze the target nerves (infrapatellar branch of the saphenous nerve \& anterior femoral cutaneous nerve) guided by ultrasound visualization.

OTHER

Neuromuscular exercise (GLA:D)

The GLA:D program, is a standard education and exercise program for patients with osteoarthritis in Denmark. The program is performed in groups and with the supervision of an experienced physiotherapist specialized in training of musculoskeletal disorders.

DEVICE

Sham

The sham intervention includes a similar procedure but without freezing temperatures.

Sponsors & Collaborators

• Odense University Hospital

  collaborator OTHER

• Esbjerg Hospital - University Hospital of Southern Denmark

  lead OTHER

Principal Investigators

• Bibi (Valgerdur) Gram, PhD · Esbjerg Hospital - University Hospital of Southern Denmark

• Carsten Kock-Jensen, MD · Esbjerg Hospital - University Hospital of Southern Denmark

• Niels-Peter B Nielsen, PhD · Esbjerg Hospital - University Hospital of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-26

Primary Completion

2023-03-01

Completion

2023-03-01

Countries

• Denmark

Study Locations