Cryoneurolysis for the Management of Chronic Pain in Patients With Knee Osteoarthritis
CompletedNot applicableNCT03774121
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Cryoneurolysis for the Management of Chronic Pain in Patients With Knee Osteoarthritis; A Randomized Controlled Study
- Conditions
- Interventions
- Device: Cryoneurolysis
- Other: Neuromuscular exercise (GLA:D)
- Device: Sham
- Sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Collaborators
- Odense University Hospital
- Start date
- 2019-06-26
- Primary completion
- 2023-03-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Referred to GLA:D by a physician. * Age ≥ 18y * Chronic knee pain for a minimum duration of 6 months. * Pain intensity ≥ 40mm on a 100mm visual analogue scale (VAS). * Radiographic confirmation of osteoarthritis; Grade 2-4 changes according to the Kellgren Lawrence classification system * A decrease of ≥ 50 % in VAS scores with diagnostic genicular nerve block. * Written and oral understanding of Danish. Exclusion Criteria: * History of systemic inflammatory conditions such as rheumatoid arthritis. * Previous recipient of cryoneurolysis for the knee. * Use of hyaluronic acid within the previous 30 days. * Injection of corticosteroid within the previous 3 months. * Clinical significant structural abnormities affecting locomotion and knee function aside from osteoarthritis and which might cause chronic knee pain. * Body mass index ≥ 18 and ≤ 40 kg/m * In treatment for other pain conditions. * Pregnancy * Coagulopathy * Uncontrolled serious disease (cancer, diabetes, etc.) * Disease associated with reactions to cold, such as cryoglobulinemia, cold urticarial and Renaud's syndrome.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03774121