Cryotherapy and Doppler in Inflammatory Rheumatic Diseases

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis; Crystal-induced Arthritides; Spondyloarthritis
• Interventions: Device: ice; Device: cold gas

• Registration Number: NCT02573298
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Status Verified: 2016-07
• Primary Completion: 2017-03-09
• Study Completion: 2017-03-09
• Last Update Submitted: 2017-03-17
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ice	ice	patients randomized to receive local ice on inflamed joint
Cold gas	cold gas	patients randomized to receive cold gas on inflamed joint

Primary Outcome Measures

Name	Time	Method
IL-6 levels in knee synovial fluid change (Multiplex, cytometry)	Baseline, 24 hours	synovial fluid was analysed at baseline, then 24 hours later (after the last ultrasonographic examination)
Power Doppler score change (Naredo's 0-3 semi-quantitative scale)	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.

Secondary Outcome Measures

Name	Time	Method
IL-1beta, TNF-alpha, IL-17, VEGF level changes in the synovial fluid (Multiplex, cytometry)	Baseline, 24 hours
pain VAS change (numeric scale)	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)	Baseline, 24 hours
skin temperature change (°C, skin temperature probe in the application area)	Baseline, 2 minutes, 2 hours, 8 hours, 24 hours	Skin temperature will be measured during each ultrasonographic examination

Trial Locations

Locations (1)

Centre hospitalier universitaire de Besançon; 🇫🇷 Besançon, Franche-Comté, France