Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02706028
Status:
COMPLETED
Last Update Posted:
2016-03-11
First Post:
2016-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-07', 'studyFirstSubmitDate': '2016-02-29', 'studyFirstSubmitQcDate': '2016-03-07', 'lastUpdatePostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in erythrocyte sedimentation rate', 'timeFrame': 'week 0 and week 2', 'description': 'change from baseline erythrocyte sedimentation rate (ESR) at Week 2'}, {'measure': 'change in erythrocyte sedimentation rate', 'timeFrame': 'week 0 and week 14', 'description': 'change from baseline erythrocyte sedimentation rate (ESR) at Week 14'}, {'measure': 'change in C-reactive protein', 'timeFrame': 'week 0 and week 2', 'description': 'change from baseline C-reactive protein (CRP) at Week 2'}, {'measure': 'change in C-reactive protein', 'timeFrame': 'week 0 and week 14', 'description': 'change from baseline C-reactive protein (CRP) at Week 14'}, {'measure': 'change in disease activity', 'timeFrame': 'week 0 and week 2', 'description': 'change from baseline disease activity score (DAS28) at week 2'}, {'measure': 'change in disease activity', 'timeFrame': 'week 0 and week 14', 'description': 'change from baseline disease activity score (DAS28) at week 14'}, {'measure': 'change in number of painful and swollen joints', 'timeFrame': 'week 0 and week 2', 'description': 'change from baseline number of painful and swollen joints at week 2'}, {'measure': 'change in number of painful and swollen joints', 'timeFrame': 'week 0 and week 14', 'description': 'change from baseline number of painful and swollen joints at week 14'}, {'measure': 'change in severity of pain at rest', 'timeFrame': 'week 0 and week 2', 'description': 'change from baseline severity of pain at rest recorded on a 10 cm visual analogue scale (VAS) at week2'}, {'measure': 'change in severity of pain at rest', 'timeFrame': 'week 0 and week 14', 'description': 'change from baseline severity of pain at rest recorded on a 10 cm visual analogue scale (VAS) at week 14'}, {'measure': 'change in duration of morning stiffness', 'timeFrame': 'week 0 and week2', 'description': 'change from baseline duration of morning joint stiffness (minutes) at Week 2'}, {'measure': 'change in duration of morning stiffness', 'timeFrame': 'week 0 nd week 14', 'description': 'change from baseline duration of morning joint stiffness (minutes) at Week 14'}], 'secondaryOutcomes': [{'measure': 'change in joint function (range of motion of the wrist)', 'timeFrame': 'week 0 and week 2', 'description': 'change from baseline range of motion in the wrists (degrees) at week 2'}, {'measure': 'change in joint function (range of motion of the wrist)', 'timeFrame': 'week 0 and week 14', 'description': 'change from baseline range of motion in the wrists (degrees) at week 14'}, {'measure': 'change in degree of fist making', 'timeFrame': 'week 0 and week 2', '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'}, {'measure': 'change in degree of fist making', 'timeFrame': 'week 0 and week14', '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'}, {'measure': 'change in hand grip strength', 'timeFrame': 'week 0 and week 2', 'description': 'change from baseline hand grip strength (kg) at week 2'}, {'measure': 'change in hand grip strength', 'timeFrame': 'week 0 and week 14', 'description': 'change from baseline hand grip strength (kg) at week 14'}, {'measure': 'change in quality of life', 'timeFrame': 'week 0 and week 2', 'description': 'change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 2'}, {'measure': 'change from baseline quality of life', 'timeFrame': 'week 0 and week 14', 'description': 'change from baseline quality of life (Health Assessment Questionnaire (HAQ) at week 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['underwater ultrasound', 'rheumatoid arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '28442212', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* No distinction was made between seropositive and seronegative patients (regarding rheumatoid factor and anti-citrullinated peptide antibody)\n* a stable-dose pharmacotherapy (DMARDs therapy), NSAIDs, steroid) given for at least 2 months\n* no physiotherapy within 1 month before starting the study\n\nExclusion Criteria:\n\n* included high disease activity (DAS28 \\> 5.1) and remission (DAS28 \\< 2.6)\n* other concomitant autoimmune diseases\n* stable-dose pharmacotherapy for less than 2 months\n* conditions contraindicating US therapy (severe osteoporosis when T-score \\< -3.5; infection; fever; osteomyelitis; pregnancy; untreated high blood pressure)\n* physiotherapy within 1 month before starting the study'}, 'identificationModule': {'nctId': 'NCT02706028', 'briefTitle': 'Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Petz Aladar County Teaching Hospital'}, 'officialTitle': 'Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis - a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'PetzACTH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ultrasound group', '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.', 'interventionNames': ['Device: underwater ultrasound']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', '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.', 'interventionNames': ['Device: sham underwater ultrasound']}], 'interventions': [{'name': 'underwater ultrasound', 'type': 'DEVICE', '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.', 'armGroupLabels': ['ultrasound group']}, {'name': 'sham underwater ultrasound', 'type': 'DEVICE', 'description': 'ULTRON home OE-302® device is not turned on', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9025', 'city': 'Győr', 'state': 'Válassza Ki A Megyét', 'country': 'Hungary', 'facility': 'Petz Aladár County Teaching Hospital', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Petz Aladar County Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Márta Király', 'investigatorAffiliation': 'Petz Aladar County Teaching Hospital'}}}}