Cryotherapy and Doppler in Inflammatory Rheumatic Diseases (CDRI)

March 17, 2017 updated by: Centre Hospitalier Universitaire de Besancon

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Franche-Comté
      • Besançon, Franche-Comté, France, 25000
        • Centre Hospitalier Universitaire de Besancon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ice
patients randomized to receive local ice on inflamed joint
Device: ice
local ice application for 30 minutes
Other Names:
  • ice pack
ACTIVE_COMPARATOR: Cold gas
patients randomized to receive cold gas on inflamed joint
Device: cold gas
local cold gas application for 2 minutes
Other Names:
  • Cryo+ (pulsed hyperbaric CO2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Power Doppler score change (Naredo's 0-3 semi-quantitative scale)
Time Frame: 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.
Baseline, 2 minutes, 2 hours, 8 hours, 24 hours
IL-6 levels in knee synovial fluid change (Multiplex, cytometry)
Time Frame: Baseline, 24 hours
synovial fluid was analysed at baseline, then 24 hours later (after the last ultrasonographic examination)
Baseline, 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain VAS change (numeric scale)
Time Frame: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours
pain VAS (mm) was recorded at each ultrasonographic examination
Baseline, 2 minutes, 2 hours, 8 hours, 24 hours
synovial fluid leukocyte count change (per mm3)
Time Frame: Baseline, 24 hours
Baseline, 24 hours
IL-1beta, TNF-alpha, IL-17, VEGF level changes in the synovial fluid (Multiplex, cytometry)
Time Frame: Baseline, 24 hours
Baseline, 24 hours
skin temperature change (°C, skin temperature probe in the application area)
Time Frame: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours
Skin temperature will be measured during each ultrasonographic examination
Baseline, 2 minutes, 2 hours, 8 hours, 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

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

Investigators

  • Principal Investigator: Xavier GUILLOT, MD, Centre Hospitalier Universitaire de Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

March 9, 2017

Study Completion (ACTUAL)

March 9, 2017

Study Registration Dates

First Submitted

October 7, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (ESTIMATE)

October 9, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2012/148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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