Cryotherapy and Doppler in Inflammatory Rheumatic Diseases

Rheumatoid Arthritis Clinical Trial

— CDRI  

Official title:

Cryotherapy and Doppler in Inflammatory Rheumatic Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573298
• Other study ID #: P/2012/148
• Status: Completed
• Phase: N/A
• First received: October 7, 2015
• Last updated: March 17, 2017
• Start date: February 2013
• Est. completion date: March 9, 2017

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 9, 2017
• Est. primary completion date: March 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Collagen Diseases
• Crystal-induced Arthritides
• Rheumatic Diseases
• Rheumatoid Arthritis
• Spondylarthritis
• Spondyloarthritis

Intervention

Device:
• ice
local ice application for 30 minutes
• cold gas
local cold gas application for 2 minutes

Locations

Country	Name	City	State
France	Centre hospitalier universitaire de Besançon	Besançon	Franche-Comté

Sponsors (5)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Clinical Investigation Centre for Innovative Technology Network, Etablissement Français du Sang, Groupement Interrégional de Recherche Clinique et d'Innovation, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Guillot X, Tordi N, Mourot L, Demougeot C, Dugué 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Power Doppler score change (Naredo's 0-3 semi-quantitative scale)	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.	Baseline, 2 minutes, 2 hours, 8 hours, 24 hours
Primary	IL-6 levels in knee synovial fluid change (Multiplex, cytometry)	synovial fluid was analysed at baseline, then 24 hours later (after the last ultrasonographic examination)	Baseline, 24 hours
Secondary	pain VAS change (numeric scale)	pain VAS (mm) was recorded at each ultrasonographic examination	Baseline, 2 minutes, 2 hours, 8 hours, 24 hours
Secondary	synovial fluid leukocyte count change (per mm3)		Baseline, 24 hours
Secondary	IL-1beta, TNF-alpha, IL-17, VEGF level changes in the synovial fluid (Multiplex, cytometry)		Baseline, 24 hours
Secondary	skin temperature change (°C, skin temperature probe in the application area)	Skin temperature will be measured during each ultrasonographic examination	Baseline, 2 minutes, 2 hours, 8 hours, 24 hours