Cryotherapy and Doppler in Inflammatory Rheumatic Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-03-09

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis Crystal-induced Arthritides Spondyloarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ice

patients randomized to receive local ice on inflamed joint

Group Type ACTIVE_COMPARATOR

ice

Intervention Type DEVICE

local ice application for 30 minutes

Cold gas

patients randomized to receive cold gas on inflamed joint

Group Type ACTIVE_COMPARATOR

cold gas

Intervention Type DEVICE

local cold gas application for 2 minutes

Interventions

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ice

local ice application for 30 minutes

Intervention Type DEVICE

cold gas

local cold gas application for 2 minutes

Intervention Type DEVICE

Other Intervention Names

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ice pack Cryo+ (pulsed hyperbaric CO2)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No