Rheumatoid Arthritis
Conditions
Keywords
underwater ultrasound, rheumatoid arthritis
Brief summary
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.
Interventions
DEVICEunderwater ultrasound
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.
DEVICEsham underwater ultrasound
ULTRON home OE-302® device is not turned on
Sponsors
Petz Aladar County Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years of age with mild-to-moderate (DAS28 \> 3.2 and \< 5.1) rheumatoid arthritis meeting the American College of Rheumatology (ACR) diagnostic criteria * No distinction was made between seropositive and seronegative patients (regarding rheumatoid factor and anti-citrullinated peptide antibody) * a stable-dose pharmacotherapy (DMARDs therapy), NSAIDs, steroid) given for at least 2 months * no physiotherapy within 1 month before starting the study
Exclusion criteria
* included high disease activity (DAS28 \> 5.1) and remission (DAS28 \< 2.6) * other concomitant autoimmune diseases * stable-dose pharmacotherapy for less than 2 months * conditions contraindicating US therapy (severe osteoporosis when T-score \< -3.5; infection; fever; osteomyelitis; pregnancy; untreated high blood pressure) * physiotherapy within 1 month before starting the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in duration of morning stiffness | week 0 and week2 | change from baseline duration of morning joint stiffness (minutes) at Week 2 |
| change in C-reactive protein | week 0 and week 2 | change from baseline C-reactive protein (CRP) at Week 2 |
| change in disease activity | week 0 and week 2 | change from baseline disease activity score (DAS28) at week 2 |
| change in number of painful and swollen joints | week 0 and week 2 | change from baseline number of painful and swollen joints at week 2 |
| change in erythrocyte sedimentation rate | week 0 and week 2 | change from baseline erythrocyte sedimentation rate (ESR) at Week 2 |
| change in severity of pain at rest | week 0 and week 2 | change from baseline severity of pain at rest recorded on a 10 cm visual analogue scale (VAS) at week2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in degree of fist making | week 0 and week 2 | change from baseline degree of fist making (based on nail tilting, 3 grades were used: 0: insufficient, 1: incomplete, 2: complete) at week 2 |
| change in hand grip strength | week 0 and week 2 | change from baseline hand grip strength (kg) at week 2 |
| change in quality of life | week 0 and week 2 | change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 2 |
| change from baseline quality of life | week 0 and week 14 | change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 14 |
| change in joint function (range of motion of the wrist) | week 0 and week 2 | change from baseline range of motion in the wrists (degrees) at week 2 |
Countries
Hungary
Outcome results
None listed