Short-wave Diathermy in Patients With Osteoarthritis of the Hand

NCT ID: NCT01838954

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-09-30

Brief Summary

Due to constant strain the joints of the hands are frequently affected by osteoarthritis (OA).

Short-wave diathermy (SWD) is a form of electromagnetic therapy, which causes movement of ions, distortion of molecules, and creation of eddy currents and as a result heat is produced in deep tissue. Its claimed mechanism of action includes inducing an anti-inflammatory response, reducing joint stiffness, stimulating connective tissue repair, and reducing muscle spasm and pain.

Since the available studies were performed to study the large weight-bearing joints only, there is a lack in scientific evidence for the efficacy of SWD in hand OA.

The aim of this randomized, double blind, placebo-controlled study is to evaluate the effect of SWD on:

joint function in patients with hand OA. joint pain in patients with hand OA. grip strength in patients with hand OA. quality of live in patients with hand OA.

Conditions

Hand Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Short-wave diathermy

Short-wave diathermy device turned on

Group Type: ACTIVE_COMPARATOR

Short-wave diathermy

Intervention Type: DEVICE

Device operating at a frequency of 27.12 MHz in continuous mode with an effective nominal output of 400 W in the patient circuit.

control

Short-wave diathermy device turned off

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Short-wave diathermy

Device operating at a frequency of 27.12 MHz in continuous mode with an effective nominal output of 400 W in the patient circuit.

Intervention Type: DEVICE

Other Intervention Names

Ultratherm (Siemens) model 808i

Eligibility Criteria

Inclusion Criteria

• Males and females > 18 years of age. All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study.
• Persistent or transient pain/aching/stiffness in at least one DIP and/or PIP joint with or without bony swelling
• Hand X-ray showing alterations typical for OA
• If NSAIDs are used to treat finger joint pain dosage must be stable for at least 4 weeks
• Able and willing to give written informed consent and to comply with the requirements of the study protocol.

Exclusion Criteria

• Prior treatment with any investigational agent within 30 days, or five half lives of the product, whichever is longer.
• Patients suffering from chronic inflammatory rheumatic disease (e.g. rheumatoid arthritis or positive rheumatoid factor or positive anti-CCP antibodies, seronegative spondylarthropathy, haemochromatosis, gout, chondrocalcinosis or other auto-immune diseases
• Stable dosage for at least 3 months with chondroitin sulfate, glucosamine, biphosphonate, corticosteroids, tetracyclines and estrogens is allowed.
• Prior use of any immunomodulating drug with possible effects on pro-inflammatory cytokine metabolism within 90 days a.o. corticosteroids, methotrexate, sulfasalazine, leflunomide, d-penicillamin, anti-malarials, cytotoxic drugs, TNF blocking agents
• If the patient is of child-bearing age, he/she must use effective means of contraception during the study.
• Use of anticoagulants (cumarins or low-molecular-weight-heparins)
• Subjects with hand OA showing or having suffered from transient inflammatory attacks of the IPJs characteristic for what has been termed 'inflammatory' or 'erosive' hand OA.
• Patient who has a known blood coagulation disorder
• metall implants (such as joint endoprothesis, pace-maker, implantable cardioverter/defibrillator, stents), piercings have to be removed prior to SWD treatment
• History of cancer or lymphoproliferative disease
• Comorbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III, IV), recent stroke (within three months), uncontrolled hypertension (defined as screening systolic blood pressure > 160 mmHg or screening diastolic blood pressure > 100 mmHg), severe pulmonary disease requiring hospitalization or supplemental oxygen
• Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
• Female subjects who are breast-feeding.
• History of clinically significant drug or alcohol abuse in the last year.
• Medical history of systemic lupus erythematosus or other connective tissue disease, RA, reactive arthritis, psoriasis
• Latex sensitivity.
• Reasonable expectation that the subject will not be able to satisfactorily complete the study. History of or current psychiatric illness, alcohol or drug abuse that would interfere with the subject's ability to comply with protocol requirements or give informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Klaus Bobacz

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Klaus Bobacz, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Department of Internal Medicine III, Division of Rheumatology, Medical University of Vienna

Vienna, Vienna, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Klaus Bobacz, MD

Role: CONTACT

klaus.bobacz@meduniwien.ac.at

+43 1 40400 ext. 4301

Miriam Gaertner, MD

Role: CONTACT

miriam.gaertner@meduniwien.ac.at

+43 1 40400 ext. 4301

Other Identifiers

MUW-1281571

Identifier Type: -

Identifier Source: org_study_id