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In this randomized, double-blind, placebo-controlled study the effects of underwater ultrasound (US) therapy were investigated in 48 patients with moderately active rheumatoid arthritis (disease activity score in 28 joints (DAS28) ≥3.2 and ≤5.1).
Patients randomly assigned to the ultrasound group (N=25) received underwater ultrasound therapy to both wrists and hands for 7 minutes per session with an intensity of 0.7 W/cm2 during 10 sessions. The control group (N=23) received sham treatment under the same conditions. At baseline, at the end of treatment (Week 2) and at the follow-up visit (Week 14), the following parameters were evaluated: disease activity - erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), tender and swollen joint counts, pain on a visual analogue scale, and DAS28, hand function (fist making, wrist extension and flexion, hand grip strength), quality of life - Health Assessment Questionnaire (HAQ), and the patients rated their own condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultrasound group | Active Comparator | Patients in the ultrasound group received underwater US therapy to both hands and wrists for 7 minutes with an intensity of 0.7 W/cm2 in a total of 10 sessions (10 working days) using a 830 kHz ULTRON home OE-302® device with treatment head size of 4.2 cm2. |
|
| control group | Sham Comparator | The control group received sham treatment (the ULTRON home OE-302® device was not turned on) during 10 sessions for 7 minutes per session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| underwater ultrasound | Device | underwater US therapy with an intensity of 0.7 W/cm2 in a total of 10 sessions (10 working days) using a 830 kHz ULTRON home OE-302® device with treatment head size of 4.2 cm2. |
| Measure | Description | Time Frame |
|---|---|---|
| change in erythrocyte sedimentation rate | change from baseline erythrocyte sedimentation rate (ESR) at Week 2 | week 0 and week 2 |
| change in erythrocyte sedimentation rate | change from baseline erythrocyte sedimentation rate (ESR) at Week 14 | week 0 and week 14 |
| change in C-reactive protein | change from baseline C-reactive protein (CRP) at Week 2 | week 0 and week 2 |
| change in C-reactive protein | change from baseline C-reactive protein (CRP) at Week 14 | week 0 and week 14 |
| change in disease activity | change from baseline disease activity score (DAS28) at week 2 | week 0 and week 2 |
| change in disease activity | change from baseline disease activity score (DAS28) at week 14 | week 0 and week 14 |
| change in number of painful and swollen joints | change from baseline number of painful and swollen joints at week 2 | week 0 and week 2 |
| change in number of painful and swollen joints | change from baseline number of painful and swollen joints at week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| change in joint function (range of motion of the wrist) | change from baseline range of motion in the wrists (degrees) at week 2 | week 0 and week 2 |
| change in joint function (range of motion of the wrist) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Petz Aladár County Teaching Hospital | Győr | Válassza Ki A Megyét | 9025 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28442212 | Derived | Kiraly M, Varga Z, Szanyo F, Kiss R, Hodosi K, Bender T. Effects of underwater ultrasound therapy on pain, inflammation, hand function and quality of life in patients with rheumatoid arthritis - a randomized controlled trial. Braz J Phys Ther. 2017 May-Jun;21(3):199-205. doi: 10.1016/j.bjpt.2017.04.002. Epub 2017 Apr 13. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| sham underwater ultrasound | Device | ULTRON home OE-302® device is not turned on |
|
| week 0 and week 14 |
| change in severity of pain at rest | change from baseline severity of pain at rest recorded on a 10 cm visual analogue scale (VAS) at week2 | week 0 and week 2 |
| change in severity of pain at rest | change from baseline severity of pain at rest recorded on a 10 cm visual analogue scale (VAS) at week 14 | week 0 and week 14 |
| change in duration of morning stiffness | change from baseline duration of morning joint stiffness (minutes) at Week 2 | week 0 and week2 |
| change in duration of morning stiffness | change from baseline duration of morning joint stiffness (minutes) at Week 14 | week 0 nd week 14 |
change from baseline range of motion in the wrists (degrees) at week 14
| week 0 and week 14 |
| change in degree of fist making | change from baseline degree of fist making (based on nail tilting, 3 grades were used: 0: insufficient, 1: incomplete, 2: complete) at week 2 | week 0 and week 2 |
| change in degree of fist making | change from baseline degree of fist making (based on nail tilting, 3 grades were used: 0: insufficient, 1: incomplete, 2: complete) at week 2 | week 0 and week14 |
| change in hand grip strength | change from baseline hand grip strength (kg) at week 2 | week 0 and week 2 |
| change in hand grip strength | change from baseline hand grip strength (kg) at week 14 | week 0 and week 14 |
| change in quality of life | change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 2 | week 0 and week 2 |
| change from baseline quality of life | change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 14 | week 0 and week 14 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |