Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clinical Investigation Centre for Innovative Technology Network | NETWORK |
| Groupement Interrégional de Recherche Clinique et d'Innovation | OTHER |
| Etablissement Français du Sang | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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):
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ice | Active Comparator | patients randomized to receive local ice on inflamed joint |
|
| Cold gas | Active Comparator | patients randomized to receive cold gas on inflamed joint |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ice | Device | local ice application for 30 minutes |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pain VAS change (numeric scale) | pain VAS (mm) was recorded at each ultrasonographic examination | Baseline, 2 minutes, 2 hours, 8 hours, 24 hours |
| synovial fluid leukocyte count change (per mm3) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xavier GUILLOT, MD | Centre Hospitalier Universitaire de Besancon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier universitaire de Besançon | Besançon | Franche-Comté | 25000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24345205 | Result | 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. | |
| 27825572 | Derived | 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. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 23, 2019 | |
| Reset | Aug 29, 2019 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 23, 2019 | Aug 29, 2019 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003791 | Dental Pulp Test |
| ID | Term |
|---|---|
| D003945 | Diagnosis, Oral |
| D003813 | Dentistry |
Not provided
Not provided
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
| cold gas | Device | local cold gas application for 2 minutes |
|
|
| 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) | Skin temperature will be measured during each ultrasonographic examination | Baseline, 2 minutes, 2 hours, 8 hours, 24 hours |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |