Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis
NCT ID: NCT02706028
Last Updated: 2016-03-11
Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2013-02-28
2014-11-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ultrasound group
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.
underwater 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.
control group
The control group received sham treatment (the ULTRON home OE-302® device was not turned on) during 10 sessions for 7 minutes per session.
sham underwater ultrasound
ULTRON home OE-302® device is not turned on
Interventions
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underwater 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.
sham underwater ultrasound
ULTRON home OE-302® device is not turned on
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Petz Aladar County Teaching Hospital
OTHER
Responsible Party
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Márta Király
chief physician
Locations
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Petz Aladár County Teaching Hospital
Győr, Válassza Ki A Megyét, Hungary
Countries
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References
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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.
Other Identifiers
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PetzACTH
Identifier Type: -
Identifier Source: org_study_id
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