The Effectiveness of Shortwave Diathermy in Knee Osteoarthritis: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Shortwave diathermy
continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Intervention: Shortwave diathermy (Device)
control
continuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Intervention: Shortwave diathermy (Device)
Outcomes
Primary Outcomes
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
- Adverse Events(3 weeks)
- 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)
Investigators
Manee Rattanachaiyanont, M.D.
Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital
Mahidol University