Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
underwater ultrasound
sham underwater ultrasound
Sponsored by

About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring underwater ultrasound, rheumatoid arthritis
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
Sites / Locations
- Petz Aladár County Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
ultrasound group
control group
Arm Description
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.
The control group received sham treatment (the ULTRON home OE-302® device was not turned on) during 10 sessions for 7 minutes per session.
Outcomes
Primary Outcome Measures
change in erythrocyte sedimentation rate
change from baseline erythrocyte sedimentation rate (ESR) at Week 2
change in erythrocyte sedimentation rate
change from baseline erythrocyte sedimentation rate (ESR) at Week 14
change in C-reactive protein
change from baseline C-reactive protein (CRP) at Week 2
change in C-reactive protein
change from baseline C-reactive protein (CRP) at Week 14
change in disease activity
change from baseline disease activity score (DAS28) at week 2
change in disease activity
change from baseline disease activity score (DAS28) at week 14
change in number of painful and swollen joints
change from baseline number of painful and swollen joints at week 2
change in number of painful and swollen joints
change from baseline number of painful and swollen joints at 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
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
change in duration of morning stiffness
change from baseline duration of morning joint stiffness (minutes) at Week 2
change in duration of morning stiffness
change from baseline duration of morning joint stiffness (minutes) at Week 14
Secondary Outcome Measures
change in joint function (range of motion of the wrist)
change from baseline range of motion in the wrists (degrees) at 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
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
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
change in hand grip strength
change from baseline hand grip strength (kg) at week 2
change in hand grip strength
change from baseline hand grip strength (kg) at week 14
change in quality of life
change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 2
change from baseline quality of life
change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 14
Full Information
NCT ID
NCT02706028
First Posted
February 29, 2016
Last Updated
March 7, 2016
Sponsor
Petz Aladar County Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02706028
Brief Title
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
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Petz Aladar County Teaching Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
underwater ultrasound, rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ultrasound group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
The control group received sham treatment (the ULTRON home OE-302® device was not turned on) during 10 sessions for 7 minutes per session.
Intervention Type
Device
Intervention Name(s)
underwater ultrasound
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham underwater ultrasound
Intervention Description
ULTRON home OE-302® device is not turned on
Primary Outcome Measure Information:
Title
change in erythrocyte sedimentation rate
Description
change from baseline erythrocyte sedimentation rate (ESR) at Week 2
Time Frame
week 0 and week 2
Title
change in erythrocyte sedimentation rate
Description
change from baseline erythrocyte sedimentation rate (ESR) at Week 14
Time Frame
week 0 and week 14
Title
change in C-reactive protein
Description
change from baseline C-reactive protein (CRP) at Week 2
Time Frame
week 0 and week 2
Title
change in C-reactive protein
Description
change from baseline C-reactive protein (CRP) at Week 14
Time Frame
week 0 and week 14
Title
change in disease activity
Description
change from baseline disease activity score (DAS28) at week 2
Time Frame
week 0 and week 2
Title
change in disease activity
Description
change from baseline disease activity score (DAS28) at week 14
Time Frame
week 0 and week 14
Title
change in number of painful and swollen joints
Description
change from baseline number of painful and swollen joints at week 2
Time Frame
week 0 and week 2
Title
change in number of painful and swollen joints
Description
change from baseline number of painful and swollen joints at week 14
Time Frame
week 0 and week 14
Title
change in severity of pain at rest
Description
change from baseline severity of pain at rest recorded on a 10 cm visual analogue scale (VAS) at week2
Time Frame
week 0 and week 2
Title
change in severity of pain at rest
Description
change from baseline severity of pain at rest recorded on a 10 cm visual analogue scale (VAS) at week 14
Time Frame
week 0 and week 14
Title
change in duration of morning stiffness
Description
change from baseline duration of morning joint stiffness (minutes) at Week 2
Time Frame
week 0 and week2
Title
change in duration of morning stiffness
Description
change from baseline duration of morning joint stiffness (minutes) at Week 14
Time Frame
week 0 nd week 14
Secondary Outcome Measure Information:
Title
change in joint function (range of motion of the wrist)
Description
change from baseline range of motion in the wrists (degrees) at week 2
Time Frame
week 0 and week 2
Title
change in joint function (range of motion of the wrist)
Description
change from baseline range of motion in the wrists (degrees) at week 14
Time Frame
week 0 and week 14
Title
change in degree of fist making
Description
change from baseline degree of fist making (based on nail tilting, 3 grades were used: 0: insufficient, 1: incomplete, 2: complete) at week 2
Time Frame
week 0 and week 2
Title
change in degree of fist making
Description
change from baseline degree of fist making (based on nail tilting, 3 grades were used: 0: insufficient, 1: incomplete, 2: complete) at week 2
Time Frame
week 0 and week14
Title
change in hand grip strength
Description
change from baseline hand grip strength (kg) at week 2
Time Frame
week 0 and week 2
Title
change in hand grip strength
Description
change from baseline hand grip strength (kg) at week 14
Time Frame
week 0 and week 14
Title
change in quality of life
Description
change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 2
Time Frame
week 0 and week 2
Title
change from baseline quality of life
Description
change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 14
Time Frame
week 0 and week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Petz Aladár County Teaching Hospital
City
Győr
State/Province
Válassza ki a megyét
ZIP/Postal Code
9025
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28442212
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.
Results Reference
derived
Learn more about this trial
Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis
We'll reach out to this number within 24 hrs