Short-wave Diathermy in Patients With Osteoarthritis of the Hand

April 9, 2015 updated by: Klaus Bobacz, Medical University of Vienna

The Effect of Short-wave Diathermy in Patients With Osteoarthritis of the Hand: A Randomized, Double Blinded, Placebo Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Department of Internal Medicine III, Division of Rheumatology, Medical University of Vienna
        • Principal Investigator:
          • Klaus Bobacz, MD
        • Sub-Investigator:
          • Miriam Gaertner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Ultratherm (Siemens) model 808i
Placebo Comparator: control
Short-wave diathermy device turned off

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
week 0, week 4, week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
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
week 0, week 4, week 12
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
week 0, week 4, week 12
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
week 0, week 4, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Klaus Bobacz, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

April 19, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUW-1281571

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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