Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT02706028
- Lead Sponsor
- Petz Aladar County Teaching Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method change in erythrocyte sedimentation rate week 0 and week 14 change from baseline erythrocyte sedimentation rate (ESR) at Week 14
change in disease activity week 0 and week 14 change from baseline disease activity score (DAS28) at week 14
change in severity of pain at rest week 0 and week 14 change from baseline severity of pain at rest recorded on a 10 cm visual analogue scale (VAS) at week 14
change in duration of morning stiffness week 0 nd week 14 change from baseline duration of morning joint stiffness (minutes) at Week 14
change in C-reactive protein week 0 and week 14 change from baseline C-reactive protein (CRP) at Week 14
change in number of painful and swollen joints week 0 and week 14 change from baseline number of painful and swollen joints at week 14
- Secondary Outcome Measures
Name Time Method change in joint function (range of motion of the wrist) week 0 and week 14 change from baseline range of motion in the wrists (degrees) at week 14
change in degree of fist making week 0 and week14 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 14 change from baseline hand grip strength (kg) at week 14
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
Trial Locations
- Locations (1)
Petz Aladár County Teaching Hospital
🇭🇺Győr, Válassza ki a megyét, Hungary
Petz Aladár County Teaching Hospital🇭🇺Győr, Válassza ki a megyét, Hungary