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

NCT ID: NCT00199914

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2004-06-30

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.

Conditions

Osteoarthritis, Knee; Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Shortwave diathermy

continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

Group Type: EXPERIMENTAL

Shortwave diathermy

Intervention Type: DEVICE

continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

control

continuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

Group Type: SHAM_COMPARATOR

Shortwave diathermy

Intervention Type: DEVICE

continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

Interventions

Shortwave diathermy

continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Manee Rattanachaiyanont, M.D.

Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manee Rattanachaiyanont, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

References

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.

Reference Type: RESULT

PMID: 18178111 (View on PubMed)

Other Identifiers

34/2003

Identifier Type: -

Identifier Source: org_study_id