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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee; Menopause
• Intervention / Treatment: Device: Shortwave diathermy

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shortwave diathermy; continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	Device: Shortwave diathermy; continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Sham Comparator: control; continuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks	Device: Shortwave diathermy; continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Gait Speed (Calculated From the Time Spending for 100-meter Walk)	3 weeks
Global Improvement	3 weeks
Patient's Satisfaction to the Treatment	3 weeks
Adverse Events	3 weeks

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Manee Rattanachaiyanont, M.D., Mahidol University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): May 1, 2004
• Study Completion (Actual): June 1, 2004

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: September 17, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee; Diathermy; Short-wave therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Body Temperature Changes; Heat Stress Disorders; Osteoarthritis; Osteoarthritis, Knee; Hyperthermia
• Other Study ID Numbers: 34/2003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The present study start date was before January 18, 2017; therefore we did not plan to share IPD. However, the IPD is available upon request to the correspondent.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No