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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
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.
ULTRON home OE-302® device is not turned on
Petz Aladár County Teaching Hospital
Győr, Válassza Ki A Megyét, Hungary
change in erythrocyte sedimentation rate
change from baseline erythrocyte sedimentation rate (ESR) at Week 2
Time frame: week 0 and week 2
change in erythrocyte sedimentation rate
change from baseline erythrocyte sedimentation rate (ESR) at Week 14
Time frame: week 0 and week 14
change in C-reactive protein
change from baseline C-reactive protein (CRP) at Week 2
Time frame: week 0 and week 2
change in C-reactive protein
change from baseline C-reactive protein (CRP) at Week 14
Time frame: week 0 and week 14
change in disease activity
change from baseline disease activity score (DAS28) at week 2
Time frame: week 0 and week 2
change in disease activity
change from baseline disease activity score (DAS28) at week 14
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: week 0 and week 14
change in duration of morning stiffness
change from baseline duration of morning joint stiffness (minutes) at Week 2
Time frame: week 0 and week2
change in duration of morning stiffness
change from baseline duration of morning joint stiffness (minutes) at Week 14
Time frame: week 0 nd week 14
change in joint function (range of motion of the wrist)
change from baseline range of motion in the wrists (degrees) at week 2
Time frame: week 0 and week 2
change in joint function (range of motion of the wrist)
change from baseline range of motion in the wrists (degrees) at week 14
Time frame: 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
Time frame: 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
Time frame: week 0 and week14
change in hand grip strength
change from baseline hand grip strength (kg) at week 2
Time frame: week 0 and week 2
change in hand grip strength
change from baseline hand grip strength (kg) at week 14
Time frame: week 0 and week 14
change in quality of life
change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 2
Time frame: week 0 and week 2
change from baseline quality of life
change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 14
Time frame: week 0 and week 14
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