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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 April 2016
Main ID:  NCT02706028
Date of registration: 29/02/2016
Prospective Registration: No
Primary sponsor: Petz Aladar County Teaching Hospital
Public title: Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis
Scientific title: Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis - a Randomized Controlled Study
Date of first enrolment: February 2013
Target sample size: 50
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02706028
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Hungary
Contacts
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Device: underwater ultrasound
Device: sham underwater ultrasound
Primary Outcome(s)
change in C-reactive protein [Time Frame: week 0 and week 14]
change in duration of morning stiffness [Time Frame: week 0 nd week 14]
change in erythrocyte sedimentation rate [Time Frame: week 0 and week 14]
change in number of painful and swollen joints [Time Frame: week 0 and week 2]
change in duration of morning stiffness [Time Frame: week 0 and week2]
change in severity of pain at rest [Time Frame: week 0 and week 2]
change in disease activity [Time Frame: week 0 and week 14]
change in number of painful and swollen joints [Time Frame: week 0 and week 14]
change in severity of pain at rest [Time Frame: week 0 and week 14]
change in C-reactive protein [Time Frame: week 0 and week 2]
change in disease activity [Time Frame: week 0 and week 2]
change in erythrocyte sedimentation rate [Time Frame: week 0 and week 2]
Secondary Outcome(s)
change from baseline quality of life [Time Frame: week 0 and week 14]
change in hand grip strength [Time Frame: week 0 and week 14]
change in degree of fist making [Time Frame: week 0 and week14]
change in degree of fist making [Time Frame: week 0 and week 2]
change in hand grip strength [Time Frame: week 0 and week 2]
change in joint function (range of motion of the wrist) [Time Frame: week 0 and week 14]
change in joint function (range of motion of the wrist) [Time Frame: week 0 and week 2]
change in quality of life [Time Frame: week 0 and week 2]
Secondary ID(s)
PetzACTH
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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