NCT02706028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
Last Updated

March 11, 2016

Status Verified

March 1, 2016

Enrollment Period

1.6 years

First QC Date

February 29, 2016

Last Update Submit

March 7, 2016

Conditions

Rheumatoid Arthritis

Keywords

underwater ultrasoundrheumatoid arthritis

Outcome Measures

Primary Outcomes (12)

  • change in erythrocyte sedimentation rate

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

    week 0 and week 2

  • change in erythrocyte sedimentation rate

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

    week 0 and week 14

  • change in C-reactive protein

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

    week 0 and week 2

  • change in C-reactive protein

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

    week 0 and week 14

  • change in disease activity

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

    week 0 and week 2

  • change in disease activity

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

    week 0 and week 14

  • change in number of painful and swollen joints

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

    week 0 and week 2

  • change in number of painful and swollen joints

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

    week 0 and 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

    week 0 and week 2

  • 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

    week 0 and week 14

  • change in duration of morning stiffness

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

    week 0 and week2

  • change in duration of morning stiffness

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

    week 0 nd week 14

Secondary Outcomes (8)

  • change in joint function (range of motion of the wrist)

    week 0 and week 2

  • change in joint function (range of motion of the wrist)

    week 0 and week 14

  • change in degree of fist making

    week 0 and week 2

  • change in degree of fist making

    week 0 and week14

  • change in hand grip strength

    week 0 and week 2

  • +3 more secondary outcomes

Study Arms (2)

ultrasound group

ACTIVE COMPARATOR

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.

Device: underwater ultrasound

control group

SHAM COMPARATOR

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

Device: sham underwater ultrasound

Interventions

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.

ultrasound group
sham underwater ultrasoundDEVICE

ULTRON home OE-302® device is not turned on

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Petz Aladár County Teaching Hospital

Győr, Válassza Ki A Megyét, 9025, Hungary

Location

Related Publications (1)

  • 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.

    PMID: 28442212DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 11, 2016

Study Start

February 1, 2013

Primary Completion

September 1, 2014

Study Completion

November 1, 2014

Last Updated

March 11, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)