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

NCT03774121 | Completed

• 1 other identifier: CryoKnee01
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cryoneurolysis; Exercise; Pain; Physical capacity

Outcome Measures

Primary Outcomes (1)

• Change in NRS knee pain intensity score

  NRS consists of a numerical, from 0 to 10, anchored by two verbal descriptors, "no pain" for the score of zero and "worst pain imaginable" for the score of 10. NRS is a self-reported tool where the respondent is asked their current pain intensity.

  Change in NRS pain score, between baseline and two weeks post surgery

Secondary Outcomes (15)

• Change in Pain location

  Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.

• Change in Functional Performance Evaluated by the 30 second chair-stand test.

  Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.

• Change in use of Analgesics

  Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.

• Number of Adverse effects

  Reported adverse effects 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.

• Change in Pain type

  Change between baseline, 2 weeks post cryoneurolysis, post GLA;D and at 6, 12 and 24 month follow-up.

Study Arms (2)

CRYO

EXPERIMENTAL

Subjected to Cryoneurolysis treatment and Neuromuscular training (GLA:D).

Device: Cryoneurolysis; Other: Neuromuscular exercise (GLA:D)

SHAM

SHAM COMPARATOR

Subjected to similar procedures as CRYO, but without freezing temperatures. Subjected to Neuromuscular training (GLA:D).

Other: Neuromuscular exercise (GLA:D); Device: Sham

Interventions

Cryoneurolysis DEVICE

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.

Also known as: Cryoablation

CRYO

Neuromuscular exercise (GLA:D) OTHER

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.

CRYO; SHAM

Sham DEVICE

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

SHAM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• Odense University Hospital: collaborator

Study Sites (1)

Hospital of Southwest Jutland

Esbjerg, Region Syddanmark, 6700, Denmark

Location

Related Publications (10)

• SUNDERLAND S. A classification of peripheral nerve injuries producing loss of function. Brain. 1951 Dec;74(4):491-516. doi: 10.1093/brain/74.4.491. No abstract available.

  PMID: 14895767 BACKGROUND

• Ilfeld BM, Preciado J, Trescot AM. Novel cryoneurolysis device for the treatment of sensory and motor peripheral nerves. Expert Rev Med Devices. 2016 Aug;13(8):713-25. doi: 10.1080/17434440.2016.1204229. Epub 2016 Jul 13.

  PMID: 27333989 BACKGROUND

• Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.

  PMID: 28336454 BACKGROUND

• Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.

  PMID: 16880882 BACKGROUND

• Skou ST, Roos EM. Good Life with osteoArthritis in Denmark (GLA:D): evidence-based education and supervised neuromuscular exercise delivered by certified physiotherapists nationwide. BMC Musculoskelet Disord. 2017 Feb 7;18(1):72. doi: 10.1186/s12891-017-1439-y.

  PMID: 28173795 BACKGROUND

• Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016 Jun;23(3):523-8. doi: 10.1016/j.knee.2016.01.011. Epub 2016 Feb 10.

  PMID: 26875052 BACKGROUND

• Lewis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2015 Apr;114(4):551-61. doi: 10.1093/bja/aeu441. Epub 2014 Dec 26.

  PMID: 25542191 BACKGROUND

• O'Brien T, Breivik H. The impact of chronic pain-European patients' perspective over 12 months. Scand J Pain. 2012 Jan 1;3(1):23-29. doi: 10.1016/j.sjpain.2011.11.004.

  PMID: 29913762 BACKGROUND

• Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010 Jun 17;11:126. doi: 10.1186/1471-2474-11-126.

  PMID: 20565735 BACKGROUND

• Nygaard NB, Koch-Jensen C, Vaegter HB, Wedderkopp N, Blichfeldt-Eckhardt M, Gram B. Cryoneurolysis for the management of chronic pain in patients with knee osteoarthritis; a double-blinded randomized controlled sham trial. BMC Musculoskelet Disord. 2021 Feb 26;22(1):228. doi: 10.1186/s12891-021-04102-1.

  PMID: 33637085 DERIVED

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis, Knee; Motor Activity; Pain

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Bibi (Valgerdur) Gram, PhD

  Esbjerg Hospital - University Hospital of Southern Denmark

  STUDY DIRECTOR

• Carsten Kock-Jensen, MD

  Esbjerg Hospital - University Hospital of Southern Denmark

  STUDY DIRECTOR

• Niels-Peter B Nielsen, PhD

  Esbjerg Hospital - University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doc, Research employee

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 12, 2018
• Study Start: June 26, 2019
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

DK (1)