Anti Inflammatory Effects of Local Cryotherapy in Knee Arthritis

NCT03850392 | Completed

• 1 other identifier: 2012-A00848-35
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

47 patients with non-septic knee arthritis were treated by local ice (30 min) or cold CO2 (2 min) twice at an 8 hour-interval for 1 day. The synovial fluid was collected just before the first cold application then 24 hours later. Cytokine, VEGF, NF-kB, PG-E2 levels were assessed in the synovial fluid before/after treatment. Contralateral arthritic knees were used as paired controls when possible.

Conditions

Arthritis Knee; Cryotherapy Effect

Keywords

cryotherapy; knee arthritis; cytokines

Outcome Measures

Primary Outcomes (1)

• Il-6 protein level change in the synovial fluid (before / after treatment)

  Multiplex cytometry technique (pg/mL)

  just before treatment (9 a.m) then 24 hours later (variation)

Secondary Outcomes (8)

• pain Visual Analogic Scale change before / after treatment

  just before treatment (9 a.m) then 24 hours later (variation)

• TNF-alpha change in the synovial fluid

  just before treatment (9 a.m) then 24 hours later (variation)

• IL-1 beta change in the synovial fluid

  just before treatment (9 a.m) then 24 hours later (variation)

• IL-17A change in the synovial fluid

  just before treatment (9 a.m) then 24 hours later (variation)

• VEGF change in the synovial fluid

  just before treatment (9 a.m) then 24 hours later (variation)

Study Arms (3)

ice

ACTIVE COMPARATOR

16 knee arthritis patients treated by local ice (Thermogel®, Artsana, Grandate, Italy - 30 minutes application - twice within one single day). Just before the first cold application, at 9 a.m., and 24 hours later (day=1 at 9 a.m), an arthrocentesis was performed. Standard analyses were performed on the synovial fluid (bacteriology, cytology and microcrystal microscopic assessment). Furthermore, a part of the synovial fluid was centrifuged then frozen at -80°C. For the second arthrocentesis, after the synovial fluid was gathered for the same analyses, an intra-joint corticosteroid injection (Triamcinolone, HEXATRIONE®,Ethypharm, Saint-Cloud, France) was performed before removing the needle.

Device: cryotherapy (Thermogel - Artsana or Cryo+ - Cryonic)

CO2

ACTIVE COMPARATOR

16 knee arthritis patients treated by local hyperbaric cold CO2 at -78°C (Cryo+®, Cryonic, Salins-les-Bains, France - 2 minutes-applied twice within one single day). Just before the first cold application, at 9 a.m., and 24 hours later (day=1 at 9 a.m), an arthrocentesis was performed. Standard analyses were performed on the synovial fluid (bacteriology, cytology and microcrystal microscopic assessment). Furthermore, a part of the synovial fluid was centrifuged then frozen at -80°C. For the second arthrocentesis, after the synovial fluid was gathered for the same analyses, an intra-joint corticosteroid injection (Triamcinolone, HEXATRIONE®, Ethypharm, Saint-Cloud, France) was performed before removing the needle.

Device: cryotherapy (Thermogel - Artsana or Cryo+ - Cryonic)

contralateral non-treated knees

NO INTERVENTION

16 contralateral arthritic knees : the synovial fluid was collected and analysed according to the same procedure but no cold treatment was applied (while the corresponding contralateral arthritic knees were treated by ice) : At 9 a.m., and 24 hours later (day=1 at 9 a.m), an arthrocentesis was performed. Standard analyses were performed on the synovial fluid (bacteriology, cytology and microcrystal microscopic assessment). Furthermore, a part of the synovial fluid was centrifuged then frozen at -80°C. For the second arthrocentesis, after the synovial fluid was gathered for the same analyses, an intra-joint corticosteroid injection (Triamcinolone, HEXATRIONE®,Ethypharm, Saint-Cloud, France) was performed before removing the needle.

Interventions

cryotherapy (Thermogel - Artsana or Cryo+ - Cryonic) DEVICE

cold application (ice 30 min or cold CO2 2 min) twice during 1 day at an 8 hour-interval

CO2; ice

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• non-septic knee arthritis

You may not qualify if:

• biologic treatment within the last 6 months, septic arthritis

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Related Publications (1)

• Guillot X, Tordi N, Laheurte C, Pazart L, Prati C, Saas P, Wendling D. Local ice cryotherapy decreases synovial interleukin 6, interleukin 1beta, vascular endothelial growth factor, prostaglandin-E2, and nuclear factor kappa B p65 in human knee arthritis: a controlled study. Arthritis Res Ther. 2019 Jul 30;21(1):180. doi: 10.1186/s13075-019-1965-0.

  PMID: 31362785 DERIVED

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the cytokine level assessment was blinded regarding the treatment arm
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: first phase : randomization ice versus cold CO2 second phase : ice-treated knees versus contralateral non-treated knees

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 21, 2019
• Study Start: February 12, 2013
• Primary Completion: March 8, 2017
• Study Completion: June 22, 2017
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share