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

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Device: underwater ultrasound; Device: sham underwater ultrasound

• 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

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-09
• Study Completion: 2014-11
• Study First Submitted: 2016-02-29
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-07
• Last Update Submitted: 2016-03-07
• Study First Posted: 2016-03-11
• Last Update Posted: 2016-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasound group	underwater ultrasound	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.
control group	sham underwater ultrasound	The control group received sham treatment (the ULTRON home OE-302® device was not turned on) during 10 sessions for 7 minutes per session.

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