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Completed

NCT Number: NCT02706028

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Petz Aladár County Teaching Hospital

Győr, Válassza Ki A Megyét, 9025, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

underwater ultrasound

Device

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 ultrasound

Device

ULTRON home OE-302® device is not turned on

Primary outcomes

  1. change in erythrocyte sedimentation rate

    Time frame: week 0 and week 2

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

  2. change in erythrocyte sedimentation rate

    Time frame: week 0 and week 14

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

  3. change in C-reactive protein

    Time frame: week 0 and week 2

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

  4. change in C-reactive protein

    Time frame: week 0 and week 14

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

  5. change in disease activity

    Time frame: week 0 and week 2

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

  6. change in disease activity

    Time frame: week 0 and week 14

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

  7. change in number of painful and swollen joints

    Time frame: week 0 and week 2

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

  8. change in number of painful and swollen joints

    Time frame: week 0 and week 14

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

  9. change in severity of pain at rest

    Time frame: week 0 and week 2

    change from baseline severity of pain at rest recorded on a 10 cm visual analogue scale (VAS) at week2

  10. change in severity of pain at rest

    Time frame: week 0 and week 14

    change from baseline severity of pain at rest recorded on a 10 cm visual analogue scale (VAS) at week 14

  11. change in duration of morning stiffness

    Time frame: week 0 and week2

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

  12. change in duration of morning stiffness

    Time frame: week 0 nd week 14

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

Secondary outcomes

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

    Time frame: week 0 and week 2

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

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

    Time frame: week 0 and week 14

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

  3. change in degree of fist making

    Time frame: week 0 and week 2

    change from baseline degree of fist making (based on nail tilting, 3 grades were used: 0: insufficient, 1: incomplete, 2: complete) at week 2

  4. change in degree of fist making

    Time frame: week 0 and week14

    change from baseline degree of fist making (based on nail tilting, 3 grades were used: 0: insufficient, 1: incomplete, 2: complete) at week 2

  5. change in hand grip strength

    Time frame: week 0 and week 2

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

  6. change in hand grip strength

    Time frame: week 0 and week 14

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

  7. change in quality of life

    Time frame: week 0 and week 2

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

  8. change from baseline quality of life

    Time frame: week 0 and week 14

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

Sponsors and collaborators

Lead sponsor

Petz Aladar County Teaching Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2016
Registry last updated
Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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