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Rheumatoid ArthritisCDRINCT02573298

Cryotherapy and Doppler in Inflammatory Rheumatic Diseases

A study testing ice and cold gas in people with Rheumatoid Arthritis and Crystal-induced Arthritides, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
ice and cold gas
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
Feb 2013to 9 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • non-septic joint arthritis with power Doppler activity( score>=1/3)

Who cannot join

  • 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
Show all 9Show fewer
  • active vasculitis
  • paroxystic haemoglobinuria
  • cryoglobulin

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre hospitalier universitaire de Besançon

    Besançon, Franche-Comté, 25000

Other trials in France

About this study

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
Read the 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.

Being tested
ice, cold gas
Keywords
cryotherapy, power Doppler score, synovial fluid cytokines, pain VAS
Medical subject headings
Arthritis, Rheumatoid, Spondylarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iceDevice

    Also called ice pack

    local ice application for 30 minutes

  • cold gasDevice

    Also called Cryo+ (pulsed hyperbaric CO2)

    local cold gas application for 2 minutes

Study groups in NCT02573298
Study groupRoleWhat they receive
IceActive comparatorpatients randomized to receive local ice on inflamed joint
Receives: Device: ice
Cold gasActive comparatorpatients randomized to receive cold gas on inflamed joint
Receives: Device: cold gas

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours

  2. 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)

    Measured: Baseline, 24 hours

Secondary outcomes (4)

  1. pain VAS change (numeric scale)

    pain VAS (mm) was recorded at each ultrasonographic examination

    Measured: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours

  2. synovial fluid leukocyte count change (per mm3)

    Measured: Baseline, 24 hours

  3. IL-1beta, TNF-alpha, IL-17, VEGF level changes in the synovial fluid (Multiplex, cytometry)

    Measured: Baseline, 24 hours

  4. skin temperature change (°C, skin temperature probe in the application area)

    Skin temperature will be measured during each ultrasonographic examination

    Measured: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2015 (estimated)
  2. Study startFeb 2013
  3. Primary completion9 Mar 2017
  4. Study completion9 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02573298
Sponsor's protocol ID
P/2012/148
Acronym
CDRI
Status last verified
Jul 2016
First submitted
7 Oct 2015
Last updated
20 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24345205

  • 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.

    PubMed 27825572

Questions about this trial

What is this clinical trial studying?

A study testing ice and cold gas in people with Rheumatoid Arthritis and Crystal-induced Arthritides, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Power Doppler score change (Naredo's 0-3 semi-quantitative scale) (time frame: Baseline, 2 minutes, 2 hours, 8 hours, 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02573298, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.

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