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Completed

NCT Number: NCT00199914

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shortwave Diathermy

Device

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

Primary outcomes

  1. The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index

    Time frame: 3 weeks

    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).

Secondary outcomes

  1. Gait Speed (Calculated From the Time Spending for 100-meter Walk)

    Time frame: 3 weeks

  2. Global Improvement

    Time frame: 3 weeks

  3. Patient's Satisfaction to the Treatment

    Time frame: 3 weeks

  4. Adverse Events

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Sep 20, 2005
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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