Osteoarthritis, Knee, Menopause
Conditions
Keywords
Diathermy, Short-wave therapy, Osteoarthritis, Knee
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.
Interventions
DEVICEShortwave diathermy
continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The treatment group received short-wave diathermy (SWD) plus exercise whereas the control group received exercise alone.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index | 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
| 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 |
Countries
Thailand
Participant flow
Recruitment details
A randomized and double blind placebo controlled equivalence trial was carried out in the out-patient clinic, Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University from January to June 2004.
Pre-assignment details
All patients had primary knee OA and without the following conditions: inability to walk, severe joint instability, history of previous SWD treatment, intra-articular injection within 3 months, metallic implant around knee joint, suspicious of malignancy around knee joint, significant cardiovascular disease.
Participants by arm
| Arm | Count |
|---|---|
| Shortwave Diathermy continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks | 53 |
| Control continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks | 60 |
| Total | 113 |
Baseline characteristics
| Characteristic | Shortwave Diathermy | Control | Total |
|---|---|---|---|
| Age, Continuous | 63.32 years STANDARD_DEVIATION 7.61 | 62.48 years STANDARD_DEVIATION 8.47 | 62.88 years STANDARD_DEVIATION 8.05 |
| Region of Enrollment Thailand | 53 participants | 60 participants | 113 participants |
| Sex: Female, Male Female | 53 Participants | 60 Participants | 113 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 50 | 4 / 54 |
| serious Total, serious adverse events | 0 / 50 | 0 / 54 |
Outcome results
Primary
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).
Time frame: 3 weeks
Population: Statistical analyses to test the superiority were based on the intention-to-treat (ITT) population, and those chosen to demonstrate the equivalence were based on the per protocol population. The worst -case-scenario was applied to the dropouts in the ITT analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Shortwave Diathermy | The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index | 0.71 units on a scale |
| Control | The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index | 0.65 units on a scale |
Secondary
Adverse Events
Time frame: 3 weeks
Secondary
Gait Speed (Calculated From the Time Spending for 100-meter Walk)
Time frame: 3 weeks
Secondary
Global Improvement
Time frame: 3 weeks
Secondary
Patient's Satisfaction to the Treatment
Time frame: 3 weeks