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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shortwave diathermy | Experimental | continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks |
|
| control | Sham Comparator | continuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shortwave diathermy | Device | continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks |
|
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manee Rattanachaiyanont, M.D. | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18178111 | Result | 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. |
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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.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Shortwave Diathermy | continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks |
| FG001 | Control | continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Shortwave Diathermy | continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks |
| BG001 | Control | continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 weeks |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Shortwave Diathermy | continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
The present study has limitations in generalizability. The study population was peri-/post-menopausal Thai women whose lifestyle might be different from that of other ethnic groups. The relatively short duration of treatment might not be sufficient to show the benefit of short-wave diathermy (SWD) treatment. Only one SWD machine with a unique output power was used in order to homogenize the provided treatment. All of these conditions would make the results in-applicable to different situations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manee Rattanachaiyanont | Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand | +66-2419-4657 | manee.rat@mahidol.ac.th |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D005334 | Fever |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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The treatment group received short-wave diathermy (SWD) plus exercise whereas the control group received exercise alone.
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| 3 weeks |
| Adverse Events | 3 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Shortwave Diathermy | continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks |
| OG001 | Control | continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks |
|
|
| Secondary | Gait Speed (Calculated From the Time Spending for 100-meter Walk) | Not Posted | 3 weeks | Participants |
| Secondary | Global Improvement | Not Posted | 3 weeks | Participants |
| Secondary | Patient's Satisfaction to the Treatment | Not Posted | 3 weeks | Participants |
| Secondary | Adverse Events | Not Posted | 3 weeks | Participants |
| 0 |
| 50 |
| 4 |
| 50 |
| EG001 | Control | continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks | 0 | 54 | 4 | 54 |
| swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| flushing | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D001832 |
| Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |