Clinical trial NCT01838954: Short-wave Diathermy in Patients With Osteoarthritis of the Hand
Official title: The Effect of Short-wave Diathermy in Patients With Osteoarthritis of the Hand: A Randomized, Double Blinded, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hand Osteoarthritis
Keywords: hand osteoarthritis
short-wave diathermy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: change in joint function in patients with hand OA (baseline, week 4 follow-up and week 12 follow-up)
timeFrame: week 0, week 4, week 12
Secondary outcomes:
measure: change in joint pain in patients with hand OA (baseline, week 4 follow-up and week 12 follow-up)
timeFrame: week 0, week 4, week 12
measure: change in grip strength in patients with hand OA (baseline, week 4 follow-up and week 12 follow-up)
timeFrame: week 0, week 4, week 12
measure: quality of live in patients with hand OA (baseline, week 4 follow-up and week 12 follow-up)
timeFrame: week 0, week 4, week 12
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Internal Medicine III, Division of Rheumatology, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Klaus Bobacz, MD
role: PRINCIPAL_INVESTIGATOR
References: