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

Phase 3
Completed
Conditions
Osteoarthritis, Knee
Menopause
Interventions
Device: Shortwave diathermy
Registration Number
NCT00199914
Lead Sponsor
Mahidol University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
113
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Shortwave diathermyShortwave diathermycontinuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
controlShortwave diathermycontinuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Primary Outcome Measures
NameTimeMethod
The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index3 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 Outcome Measures
NameTimeMethod
Global Improvement3 weeks
Patient's Satisfaction to the Treatment3 weeks
Adverse Events3 weeks
Gait Speed (Calculated From the Time Spending for 100-meter Walk)3 weeks

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

🇹🇭

Bangkok, Thailand

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