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Cryotherapy and Doppler in Inflammatory Rheumatic Diseases (CDRI)

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ClinicalTrials.gov Identifier: NCT02573298
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : March 20, 2017
Sponsor:
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
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Crystal-induced Arthritides Spondyloarthritis Device: ice Device: cold gas Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cryotherapy and Doppler in Inflammatory Rheumatic Diseases
Study Start Date : February 2013
Actual Primary Completion Date : March 9, 2017
Actual Study Completion Date : March 9, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ice
patients randomized to receive local ice on inflamed joint
Device: ice
local ice application for 30 minutes
Other Name: 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 Name: Cryo+ (pulsed hyperbaric CO2)




Primary Outcome Measures :
  1. 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.

  2. 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)


Secondary Outcome Measures :
  1. 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

  2. synovial fluid leukocyte count change (per mm3) [ Time Frame: Baseline, 24 hours ]
  3. IL-1beta, TNF-alpha, IL-17, VEGF level changes in the synovial fluid (Multiplex, cytometry) [ Time Frame: Baseline, 24 hours ]
  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573298


Locations
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France
Centre hospitalier universitaire de Besançon
Besançon, Franche-Comté, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
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
Investigators
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Principal Investigator: Xavier GUILLOT, MD Centre hospitalier universitaire de Besançon
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02573298    
Other Study ID Numbers: P/2012/148
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: July 2016
Keywords provided by Centre Hospitalier Universitaire de Besancon:
cryotherapy
power Doppler score
synovial fluid cytokines
pain VAS
Additional relevant MeSH terms:
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Arthritis
Rheumatic Diseases
Spondylarthritis
Collagen Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Spondylitis
Spinal Diseases
Bone Diseases