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Rheumatoid ArthritisNCT02706028

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

A study testing underwater ultrasound in people with Rheumatoid Arthritis, run by Petz Aladar County Teaching Hospital at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
underwater ultrasound
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteHungary
Study dates
Feb 2013to Nov 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • Petz Aladár County Teaching Hospital

    Győr, Válassza Ki A Megyét, 9025

Other trials in Hungary

About this study

Official title: Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis - a Randomized Controlled Study

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.

Being tested
underwater ultrasound, sham underwater ultrasound
Keywords
underwater ultrasound, rheumatoid arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • underwater ultrasoundDevice

    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.

  • sham underwater ultrasoundDevice

    ULTRON home OE-302® device is not turned on

Study groups in NCT02706028
Study groupRoleWhat they receive
ultrasound groupActive comparatorPatients 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.
Receives: Device: underwater ultrasound
control groupSham comparatorThe control group received sham treatment (the ULTRON home OE-302® device was not turned on) during 10 sessions for 7 minutes per session.
Receives: Device: sham underwater ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in erythrocyte sedimentation rate

    change from baseline erythrocyte sedimentation rate (ESR) at Week 2

    Measured: week 0 and week 2

  2. change in erythrocyte sedimentation rate

    change from baseline erythrocyte sedimentation rate (ESR) at Week 14

    Measured: week 0 and week 14

  3. change in C-reactive protein

    change from baseline C-reactive protein (CRP) at Week 2

    Measured: week 0 and week 2

  4. change in C-reactive protein

    change from baseline C-reactive protein (CRP) at Week 14

    Measured: week 0 and week 14

  5. change in disease activity

    change from baseline disease activity score (DAS28) at week 2

    Measured: week 0 and week 2

  6. change in disease activity

    change from baseline disease activity score (DAS28) at week 14

    Measured: week 0 and week 14

  7. change in number of painful and swollen joints

    change from baseline number of painful and swollen joints at week 2

    Measured: week 0 and week 2

  8. change in number of painful and swollen joints

    change from baseline number of painful and swollen joints at week 14

    Measured: week 0 and week 14

  9. 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

    Measured: week 0 and week 2

  10. 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

    Measured: week 0 and week 14

  11. change in duration of morning stiffness

    change from baseline duration of morning joint stiffness (minutes) at Week 2

    Measured: week 0 and week2

  12. change in duration of morning stiffness

    change from baseline duration of morning joint stiffness (minutes) at Week 14

    Measured: week 0 nd week 14

Secondary outcomes (8)

  1. change in joint function (range of motion of the wrist)

    change from baseline range of motion in the wrists (degrees) at week 2

    Measured: week 0 and week 2

  2. change in joint function (range of motion of the wrist)

    change from baseline range of motion in the wrists (degrees) at week 14

    Measured: week 0 and week 14

  3. 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

    Measured: week 0 and week 2

  4. 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

    Measured: week 0 and week14

  5. change in hand grip strength

    change from baseline hand grip strength (kg) at week 2

    Measured: week 0 and week 2

  6. change in hand grip strength

    change from baseline hand grip strength (kg) at week 14

    Measured: week 0 and week 14

  7. change in quality of life

    change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 2

    Measured: week 0 and week 2

  8. change from baseline quality of life

    change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 14

    Measured: week 0 and week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2016 (estimated)
  2. Study startFeb 2013
  3. Primary completionSep 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02706028
Sponsor's protocol ID
PetzACTH
Status last verified
Mar 2016
First submitted
29 Feb 2016
Last updated
11 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28442212

Questions about this trial

What is this clinical trial studying?

A study testing underwater ultrasound in people with Rheumatoid Arthritis, run by Petz Aladar County Teaching Hospital at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in erythrocyte sedimentation rate (time frame: week 0 and week 2). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02706028, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.

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