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Cryotherapy and Doppler in Inflammatory Rheumatic Diseases (CDRI)

Primary Purpose

Rheumatoid Arthritis, Crystal-induced Arthritides, Spondyloarthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ice
cold gas
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring cryotherapy, power Doppler score, synovial fluid cytokines, pain VAS

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre hospitalier universitaire de Besançon

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ice

Cold gas

Arm Description

patients randomized to receive local ice on inflamed joint

patients randomized to receive cold gas on inflamed joint

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

pain VAS change (numeric scale)
pain VAS (mm) was recorded at each ultrasonographic examination
synovial fluid leukocyte count change (per mm3)
IL-1beta, TNF-alpha, IL-17, VEGF level changes in the synovial fluid (Multiplex, cytometry)
skin temperature change (°C, skin temperature probe in the application area)
Skin temperature will be measured during each ultrasonographic examination

Full Information

First Posted
October 7, 2015
Last Updated
March 17, 2017
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Clinical Investigation Centre for Innovative Technology Network, Groupement Interrégional de Recherche Clinique et d'Innovation, Etablissement Français du Sang, Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02573298
Brief Title
Cryotherapy and Doppler in Inflammatory Rheumatic Diseases
Acronym
CDRI
Official Title
Cryotherapy and Doppler in Inflammatory Rheumatic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 9, 2017 (Actual)
Study Completion Date
March 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Clinical Investigation Centre for Innovative Technology Network, Groupement Interrégional de Recherche Clinique et d'Innovation, Etablissement Français du Sang, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Crystal-induced Arthritides, Spondyloarthritis
Keywords
cryotherapy, power Doppler score, synovial fluid cytokines, pain VAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ice
Arm Type
Active Comparator
Arm Description
patients randomized to receive local ice on inflamed joint
Arm Title
Cold gas
Arm Type
Active Comparator
Arm Description
patients randomized to receive cold gas on inflamed joint
Intervention Type
Device
Intervention Name(s)
ice
Other Intervention Name(s)
ice pack
Intervention Description
local ice application for 30 minutes
Intervention Type
Device
Intervention Name(s)
cold gas
Other Intervention Name(s)
Cryo+ (pulsed hyperbaric CO2)
Intervention Description
local cold gas application for 2 minutes
Primary Outcome Measure Information:
Title
Power Doppler score change (Naredo's 0-3 semi-quantitative scale)
Description
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.
Time Frame
Baseline, 2 minutes, 2 hours, 8 hours, 24 hours
Title
IL-6 levels in knee synovial fluid change (Multiplex, cytometry)
Description
synovial fluid was analysed at baseline, then 24 hours later (after the last ultrasonographic examination)
Time Frame
Baseline, 24 hours
Secondary Outcome Measure Information:
Title
pain VAS change (numeric scale)
Description
pain VAS (mm) was recorded at each ultrasonographic examination
Time Frame
Baseline, 2 minutes, 2 hours, 8 hours, 24 hours
Title
synovial fluid leukocyte count change (per mm3)
Time Frame
Baseline, 24 hours
Title
IL-1beta, TNF-alpha, IL-17, VEGF level changes in the synovial fluid (Multiplex, cytometry)
Time Frame
Baseline, 24 hours
Title
skin temperature change (°C, skin temperature probe in the application area)
Description
Skin temperature will be measured during each ultrasonographic examination
Time Frame
Baseline, 2 minutes, 2 hours, 8 hours, 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier GUILLOT, MD
Organizational Affiliation
Centre hospitalier universitaire de Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier universitaire de Besançon
City
Besançon
State/Province
Franche-Comté
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24345205
Citation
Guillot X, Tordi N, Mourot L, Demougeot C, Dugue 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. Epub 2013 Dec 18.
Results Reference
result
PubMed Identifier
27825572
Citation
Guillot X, Tordi N, Prati C, Verhoeven F, Pazart L, Wendling D. Cryotherapy decreases synovial Doppler activity and pain in knee arthritis: A randomized-controlled trial. Joint Bone Spine. 2017 Jul;84(4):477-483. doi: 10.1016/j.jbspin.2016.09.004. Epub 2016 Nov 4.
Results Reference
derived

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Cryotherapy and Doppler in Inflammatory Rheumatic Diseases

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