Short-wave Diathermy in Patients With Osteoarthritis of the Hand

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Klaus Bobacz, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01838954
First received: April 16, 2013
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Hand Osteoarthritis
Device: Short-wave diathermy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Short-wave Diathermy in Patients With Osteoarthritis of the Hand: A Randomized, Double Blinded, Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • change in joint function in patients with hand OA (baseline, week 4 follow-up and week 12 follow-up) [ Time Frame: week 0, week 4, week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in joint pain in patients with hand OA (baseline, week 4 follow-up and week 12 follow-up) [ Time Frame: week 0, week 4, week 12 ] [ Designated as safety issue: No ]
  • change in grip strength in patients with hand OA (baseline, week 4 follow-up and week 12 follow-up) [ Time Frame: week 0, week 4, week 12 ] [ Designated as safety issue: No ]
  • quality of live in patients with hand OA (baseline, week 4 follow-up and week 12 follow-up) [ Time Frame: week 0, week 4, week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Short-wave diathermy
Short-wave diathermy device turned on
Device: 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.
Other Name: Ultratherm (Siemens) model 808i
Placebo Comparator: control
Short-wave diathermy device turned off

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838954

Contacts
Contact: Klaus Bobacz, MD +43 1 40400 ext 4301 klaus.bobacz@meduniwien.ac.at
Contact: Miriam Gaertner, MD +43 1 40400 ext 4301 miriam.gaertner@meduniwien.ac.at

Locations
Austria
Department of Internal Medicine III, Division of Rheumatology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Principal Investigator: Klaus Bobacz, MD         
Sub-Investigator: Miriam Gaertner, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Klaus Bobacz, MD Medizinische Universität Wien
  More Information

No publications provided

Responsible Party: Klaus Bobacz, principal investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01838954     History of Changes
Other Study ID Numbers: MUW-1281571
Study First Received: April 16, 2013
Last Updated: April 19, 2013
Health Authority: Austria: Ethikkommission
Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medical University of Vienna:
hand osteoarthritis
short-wave diathermy

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014