Clinical trial NCT02573298: Cryotherapy and Doppler in Inflammatory Rheumatic Diseases
Official title: Cryotherapy and Doppler in Inflammatory Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Crystal-induced Arthritides
Spondyloarthritis
Keywords: cryotherapy
power Doppler score
synovial fluid cytokines
pain VAS
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
name: Groupement Interrégional de Recherche Clinique et d'Innovation
name: Etablissement Français du Sang
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2015-10-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* non-septic joint arthritis with power Doppler activity( score\>=1/3)

Exclusion Criteria:

* neurologic diseases impairing skin sensitivity
* cold allergia
* Raynaud phenomenon
* non-controlled diabetes mellitus, heart failure, heart pace abnormalities
* skin lesion on the application area
* cognitive impairments
* active vasculitis
* paroxystic haemoglobinuria
* cryoglobulin

Primary outcomes:
measure: Power Doppler score change (Naredo's 0-3 semi-quantitative scale)
timeFrame: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours
measure: IL-6 levels in knee synovial fluid change (Multiplex, cytometry)
timeFrame: Baseline, 24 hours
Secondary outcomes:
measure: pain VAS change (numeric scale)
timeFrame: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours
measure: synovial fluid leukocyte count change (per mm3)
timeFrame: Baseline, 24 hours
measure: IL-1beta, TNF-alpha, IL-17, VEGF level changes in the synovial fluid (Multiplex, cytometry)
timeFrame: Baseline, 24 hours
measure: skin temperature change (°C, skin temperature probe in the application area)
timeFrame: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre hospitalier universitaire de Besançon
state: Franche-Comté
Study officials:
affiliation: Centre Hospitalier Universitaire de Besançon
name: Xavier GUILLOT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guillot X, Tordi N, Mourot L, Demougeot C, Dugue B, Prati C, Wendling D. Cryotherapy in inflammatory rheumatic diseases: a systematic review. Expert Rev Clin Immunol. 2014 Feb;10(2):281-94. doi: 10.1586/1744666X.2014.870036. Epub 2013 Dec 18.
citation: Guillot X, Tordi N, Prati C, Verhoeven F, Pazart L, Wendling D. Cryotherapy decreases synovial Doppler activity and pain in knee arthritis: A randomized-controlled trial. Joint Bone Spine. 2017 Jul;84(4):477-483. doi: 10.1016/j.jbspin.2016.09.004. Epub 2016 Nov 4.