Efficacy Study of Shortwave Diathermy for the Treatment of Patients With Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

The Effectiveness of Shortwave Diathermy in Knee Osteoarthritis: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199914
• Other study ID #: 34/2003
• Status: Completed
• Phase: Phase 3
• Start date: January 2004
• Est. completion date: June 2004

Study information

• Verified date: September 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperthermia
• Menopause
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Shortwave diathermy
continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index	The WOMAC index is a multidimensional, self-administered health status evaluation instrument for patients with OA of the hip and knee. It is composed of 24 items that are grouped into three dimensions, including pain (5 items), stiffness (2 items), and function (17 items). The response can be in a form of visual analog or five-point Likert scale [11, 23]. In this study, the response is on a 10-cm horizontal line with numeric description from 0 to 10. The score of each dimension is an average of the component item scores. The WOMAC total score is determined by averaging the scores of all dimensions. The total score ranges from 0 (best outcome possible) to 10 (worst outcome possible).	3 weeks
Secondary	Gait Speed (Calculated From the Time Spending for 100-meter Walk)		3 weeks
Secondary	Global Improvement		3 weeks
Secondary	Patient's Satisfaction to the Treatment		3 weeks
Secondary	Adverse Events		3 weeks