Osteoarthritis, KneePhase 3NCT00199914
Efficacy Study of Shortwave Diathermy for the Treatment of Patients With Knee Osteoarthritis
A Phase 3 study testing Shortwave diathermy in people with Osteoarthritis, Knee and Menopause, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Osteoarthritis, Knee, Menopause
- What is being tested?
- Shortwave diathermy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2004to Jun 2004
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- peri- or postmenopausal women aged >50 years
- primary knee osteoarthritis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: The Effectiveness of Shortwave Diathermy in Knee Osteoarthritis: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Menopause
- Being tested
- Shortwave diathermy
- Keywords
- Diathermy, Short-wave therapy, Osteoarthritis, Knee
- Medical subject headings
- Osteoarthritis, Knee, Fever, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shortwave diathermyDevice
continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Shortwave diathermy | Experimental | continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks Receives: Device: Shortwave diathermy |
| control | Sham comparator | continuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks Receives: Device: Shortwave diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 weeks
Secondary outcomes (4)
Gait Speed (Calculated From the Time Spending for 100-meter Walk)
Measured: 3 weeks
Global Improvement
Measured: 3 weeks
Patient's Satisfaction to the Treatment
Measured: 3 weeks
Adverse Events
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionMay 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment group received short-wave diathermy (SWD) plus exercise whereas the control group received exercise alone.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manee Rattanachaiyanont, M.D., Mahidol University
- Investigators
- Manee Rattanachaiyanont, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199914
- Sponsor's protocol ID
- 34/2003
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2005
- Last updated
- 14 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 18178111
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Shortwave Diathermy in Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00199914
- Acronym / sponsor ID
- 34/2003
- Conditions
- Osteoarthritis, Knee, Menopause
- Keywords
- Diathermy, Short-wave therapy, Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- May 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 8 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The treatment group received short-wave diathermy (SWD) plus exercise whereas the control group received exercise alone.
| Arm | Type | Receives |
|---|---|---|
| Shortwave diathermy | Experimental | Device: Shortwave diathermycontinuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks |
| control | Sham comparator | Device: Shortwave diathermycontinuous sham shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- peri- or postmenopausal women aged >50 years
- primary knee osteoarthritis
Key exclusion criteria (8 listed)
- inability to walk
- severe joint instability
- history of previous shortwave diathermy
- intra-articular injection within 3 months
- metallic implant around knee joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shortwave diathermycontinuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks | Device | Shortwave diathermy, control |
Primary outcome
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).
4 secondary outcomes
Gait Speed (Calculated From the Time Spending for 100-meter Walk)
Time frame: 3 weeks
Global Improvement
Time frame: 3 weeks
Patient's Satisfaction to the Treatment
Time frame: 3 weeks
Adverse Events
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18178111Rattanachaiyanont 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manee Rattanachaiyanont, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Shortwave diathermy in people with Osteoarthritis, Knee and Menopause, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00199914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.