Cryotherapy and Doppler in Inflammatory Rheumatic Diseases (CDRI)

Centre Hospitalier Universitaire de Besancon

Status: Completed

Conditions: Crystal-induced Arthritides; Spondyloarthritis; Rheumatoid Arthritis

Treatments: Device: ice; Device: cold gas

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02573298

P/2012/148

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Ice

Active Comparator group

Description:

patients randomized to receive local ice on inflamed joint

Treatment:

Device: ice

Cold gas

Active Comparator group

Description:

patients randomized to receive cold gas on inflamed joint

Treatment:

Device: cold gas