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Completed

NCT Number: NCT02573298

Cryotherapy and Doppler in Inflammatory Rheumatic Diseases

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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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Crystal-induced Arthritides Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylitis Spondyloarthritis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier universitaire de Besançon

Besançon, Franche-Comté, 25000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICE

Device

local ice application for 30 minutes

Other names: ice pack

cold gas

Device

local cold gas application for 2 minutes

Other names: Cryo+ (pulsed hyperbaric CO2)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

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

Registry information

Acronym: CDRI

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2015
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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