NCT02573298

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2017

Completed
Last Updated

March 20, 2017

Status Verified

July 1, 2016

Enrollment Period

4.1 years

First QC Date

October 7, 2015

Last Update Submit

March 17, 2017

Conditions

Rheumatoid ArthritisCrystal-induced ArthritidesSpondyloarthritis

Keywords

cryotherapypower Doppler scoresynovial fluid cytokinespain VAS

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 2 minutes, 2 hours, 8 hours, 24 hours

  • 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)

    Baseline, 24 hours

Secondary Outcomes (4)

  • pain VAS change (numeric scale)

    Baseline, 2 minutes, 2 hours, 8 hours, 24 hours

  • synovial fluid leukocyte count change (per mm3)

    Baseline, 24 hours

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

    Baseline, 24 hours

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

    Baseline, 2 minutes, 2 hours, 8 hours, 24 hours

Study Arms (2)

Ice

ACTIVE COMPARATOR

patients randomized to receive local ice on inflamed joint

Device: ice

Cold gas

ACTIVE COMPARATOR

patients randomized to receive cold gas on inflamed joint

Device: cold gas

Interventions

iceDEVICE

local ice application for 30 minutes

Also known as: ice pack
Ice
cold gasDEVICE

local cold gas application for 2 minutes

Also known as: Cryo+ (pulsed hyperbaric CO2)
Cold gas

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier universitaire de Besançon

Besançon, Franche-Comté, 25000, France

Location

Related Publications (2)

  • 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.

    PMID: 24345205RESULT

  • 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.

    PMID: 27825572DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylarthritis

Interventions

Dental Pulp Test

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone Diseases

Intervention Hierarchy (Ancestors)

Diagnosis, OralDentistry

Study Officials

  • Xavier GUILLOT, MD

    Centre Hospitalier Universitaire de Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2015

First Posted

October 9, 2015

Study Start

February 1, 2013

Primary Completion

March 9, 2017

Study Completion

March 9, 2017

Last Updated

March 20, 2017

Record last verified: 2016-07

Locations

FR(1)