Clinical trial NCT02706028: Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis
Official title: Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: underwater ultrasound
rheumatoid arthritis
Lead sponsor: Petz Aladar County Teaching Hospital
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change in erythrocyte sedimentation rate
timeFrame: week 0 and week 2
measure: change in erythrocyte sedimentation rate
timeFrame: week 0 and week 14
measure: change in C-reactive protein
timeFrame: week 0 and week 2
measure: change in C-reactive protein
timeFrame: week 0 and week 14
measure: change in disease activity
timeFrame: week 0 and week 2
measure: change in disease activity
timeFrame: week 0 and week 14
measure: change in number of painful and swollen joints
timeFrame: week 0 and week 2
measure: change in number of painful and swollen joints
timeFrame: week 0 and week 14
measure: change in severity of pain at rest
timeFrame: week 0 and week 2
measure: change in severity of pain at rest
timeFrame: week 0 and week 14
measure: change in duration of morning stiffness
timeFrame: week 0 and week2
measure: change in duration of morning stiffness
timeFrame: week 0 nd week 14
Secondary outcomes:
measure: change in joint function (range of motion of the wrist)
timeFrame: week 0 and week 2
measure: change in joint function (range of motion of the wrist)
timeFrame: week 0 and week 14
measure: change in degree of fist making
timeFrame: week 0 and week 2
measure: change in degree of fist making
timeFrame: week 0 and week14
measure: change in hand grip strength
timeFrame: week 0 and week 2
measure: change in hand grip strength
timeFrame: week 0 and week 14
measure: change in quality of life
timeFrame: week 0 and week 2
measure: change from baseline quality of life
timeFrame: week 0 and week 14
Other outcomes:
Locations:
city: Győr
country: Hungary
facility: Petz Aladár County Teaching Hospital
state: Válassza ki a megyét
Study officials:
References:
citation: 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.