Cryotherapy and Doppler in Inflammatory Rheumatic Diseases (CDRI)
|ClinicalTrials.gov Identifier: NCT02573298|
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : March 20, 2017
The primary aim of the study is to evaluate the effects of two local cryotherapy (ice or cold gas) applications on arthritic knees.
Evaluation criteria (before/after treatment):
- synovial power-Doppler semi-quantitative score
- pain VAS (mm)
- cytokine levels in synovial fluid
- leukocyte count in synovial fluid
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Crystal-induced Arthritides Spondyloarthritis||Device: ice Device: cold gas||Not Applicable|
After informed consent, patients suffering from inflammatory rheumatic diseases (rheumatoid arthritis, spondyloarthritis, crystal-induced arthritides) with non-septic arthritides were randomized to receive either local ice (30 minutes twice a day) or cold gas (2 minutes twice a day - pulsed hyperbaric CO2). Local cryotherapy was applied at 9 AM and 17 PM.
Skin temperature was monitored Knee power Doppler ultrasonography was performed before cryotherapy (9 AM), just after, 2 min after, 2 hours after, before and after the second cold application (8 hours after the first cold application), then the day after at 9 A.M (24 hours after the first cold application).
Synovial fluid was also analysed after join arthrocentesis (just before the first cold application, then 24 hours later, after the last ultrasonographic examination. A corticosteroid injection was performed after the second arthrocentesis when necessary.
Power Doppler semi-quantitative scores (0-3) were then blindly assessed by a second trained ultrasonographist at the different times of the study.
Pain VAS evolution was also monitored throughout the study. Clinical characteristics of patients were collected at baseline. 20 patients suffering from ankle/wrist arthritides were also included in order to evaluate power Doppler score evolution under cold gas or ice-cryotherapy.
15 patients suffering from knee arthritides were treated by local cold gas. 31 patients suffering from knee arthritides were treated by ice. When both knees were arthritic, contralateral synovial fluid and power Doppler score were used as non-treated controls.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cryotherapy and Doppler in Inflammatory Rheumatic Diseases|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||March 9, 2017|
|Actual Study Completion Date :||March 9, 2017|
Active Comparator: Ice
patients randomized to receive local ice on inflamed joint
local ice application for 30 minutes
Other Name: ice pack
Active Comparator: Cold gas
patients randomized to receive cold gas on inflamed joint
Device: cold gas
local cold gas application for 2 minutes
Other Name: Cryo+ (pulsed hyperbaric CO2)
- Power Doppler score change (Naredo's 0-3 semi-quantitative scale) [ Time Frame: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours ]Semi-quantitative power Doppler score was assessed at baseline, just after, 2 min after, 2 hours after, 8 hours after (just before the second cold application then just after), 24 hours after the first cold application.
- IL-6 levels in knee synovial fluid change (Multiplex, cytometry) [ Time Frame: Baseline, 24 hours ]synovial fluid was analysed at baseline, then 24 hours later (after the last ultrasonographic examination)
- pain VAS change (numeric scale) [ Time Frame: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours ]pain VAS (mm) was recorded at each ultrasonographic examination
- synovial fluid leukocyte count change (per mm3) [ Time Frame: Baseline, 24 hours ]
- IL-1beta, TNF-alpha, IL-17, VEGF level changes in the synovial fluid (Multiplex, cytometry) [ Time Frame: Baseline, 24 hours ]
- skin temperature change (°C, skin temperature probe in the application area) [ Time Frame: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours ]Skin temperature will be measured during each ultrasonographic examination
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573298
|Centre hospitalier universitaire de Besançon|
|Besançon, Franche-Comté, France, 25000|
|Principal Investigator:||Xavier GUILLOT, MD||Centre hospitalier universitaire de Besançon|