Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis - a Randomized Controlled Study

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Device: underwater ultrasound
* Device: sham underwater ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ultrasound group<br>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. | Device: underwater ultrasound<br>* 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.<br>|
| Sham Comparator: control group<br>The control group received sham treatment (the ULTRON home OE-302® device was not turned on) during 10 sessions for 7 minutes per session. | Device: sham underwater ultrasound<br>* ULTRON home OE-302® device is not turned on<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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underwater ultrasound, rheumatoid arthritis