Clinical trial NCT00199914: Efficacy Study of Shortwave Diathermy for the Treatment of Patients With Knee Osteoarthritis
Official title: The Effectiveness of Shortwave Diathermy in Knee Osteoarthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Menopause
Keywords: Diathermy
Short-wave therapy
Osteoarthritis
Knee
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 113
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The treatment group received short-wave diathermy (SWD) plus exercise whereas the control group received exercise alone.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether shortwave diathermy is effective in reducing knee pain and increasing function of the patients with knee osteoarthritis.

Detailed description: Osteoarthritis (OA) is the most common degenerative joint disease, resulting in significant morbidity and health care expense. It affects more than 60% of Western World adults over the age of 65 years. It causes pain and dysfunction in 20% of elderly persons. It can affect any joint containing hyaline cartilage; knee is the most commonly affected joint. There are many strategies for the treatment of knee OA but a curative method has not been found. Treatment is therefore aimed to relief symptoms and to prevent further functional deterioration. It is unclear whether any of the treatment modalities is efficacious. Shortwave diathermy (SWD) is one of deep heat widely applied to alleviate the symptoms associated with OA. The efficacy of SWD for the treatment of OA knee is still inconclusive. The outcome of treatment in previous reports varies from null to positive effect. This discrepancy is largely due to the different research methodology, the inadequate sample size, the methods used in outcome assessment, and the treatment protocols.

Comparison(s): Peri- or postmenopausal women with OA knee are randomized into two groups, receiving a course of either therapeutic SWD or sham SWD. The main outcome measured is the change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index.

Eligibility criteria: Inclusion Criteria:

* peri- or postmenopausal women aged \>50 years
* primary knee osteoarthritis

Exclusion Criteria:

* inability to walk
* severe joint instability
* history of previous shortwave diathermy
* intra-articular injection within 3 months
* metallic implant around knee joint
* suspicious of malignancy around knee joint
* significant cardiovascular disease
* inability to understand how to score the symptoms

Primary outcomes:
measure: The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
timeFrame: 3 weeks
Secondary outcomes:
measure: Gait Speed (Calculated From the Time Spending for 100-meter Walk)
timeFrame: 3 weeks
measure: Global Improvement
timeFrame: 3 weeks
measure: Patient's Satisfaction to the Treatment
timeFrame: 3 weeks
measure: Adverse Events
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Manee Rattanachaiyanont, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rattanachaiyanont M, Kuptniratsaikul V. No additional benefit of shortwave diathermy over exercise program for knee osteoarthritis in peri-/post-menopausal women: an equivalence trial. Osteoarthritis Cartilage. 2008 Jul;16(7):823-8. doi: 10.1016/j.joca.2007.10.013. Epub 2008 Feb 21.