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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706028
• Other study ID #: PetzACTH
• Status: Completed
• Phase: N/A
• First received: February 29, 2016
• Last updated: March 7, 2016
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2016
• Source: Petz Aladar County Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Scientific and Medical Research Council Ethics Committee
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• underwater ultrasound
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
ULTRON home OE-302® device is not turned on

Locations

Country	Name	City	State
Hungary	Petz Aladár County Teaching Hospital	Gyor	Válassza ki a megyét

Sponsors (1)

Lead Sponsor	Collaborator
Petz Aladar County Teaching Hospital

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in erythrocyte sedimentation rate	change from baseline erythrocyte sedimentation rate (ESR) at Week 2	week 0 and week 2	No
Primary	change in erythrocyte sedimentation rate	change from baseline erythrocyte sedimentation rate (ESR) at Week 14	week 0 and week 14	No
Primary	change in C-reactive protein	change from baseline C-reactive protein (CRP) at Week 2	week 0 and week 2	No
Primary	change in C-reactive protein	change from baseline C-reactive protein (CRP) at Week 14	week 0 and week 14	No
Primary	change in disease activity	change from baseline disease activity score (DAS28) at week 2	week 0 and week 2	No
Primary	change in disease activity	change from baseline disease activity score (DAS28) at week 14	week 0 and week 14	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	change in duration of morning stiffness	change from baseline duration of morning joint stiffness (minutes) at Week 2	week 0 and week2	No
Primary	change in duration of morning stiffness	change from baseline duration of morning joint stiffness (minutes) at Week 14	week 0 nd week 14	No
Secondary	change in joint function (range of motion of the wrist)	change from baseline range of motion in the wrists (degrees) at week 2	week 0 and week 2	No
Secondary	change in joint function (range of motion of the wrist)	change from baseline range of motion in the wrists (degrees) at week 14	week 0 and week 14	No
Secondary	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	week 0 and week 2	No
Secondary	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	week 0 and week14	No
Secondary	change in hand grip strength	change from baseline hand grip strength (kg) at week 2	week 0 and week 2	No
Secondary	change in hand grip strength	change from baseline hand grip strength (kg) at week 14	week 0 and week 14	No
Secondary	change in quality of life	change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 2	week 0 and week 2	No
Secondary	change from baseline quality of life	change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 14	week 0 and week 14	No