Chronic DiseasesPSWNCT01331174
Pulsed Short Wave in Females With Knee Osteoarthritis
A study testing Pulsed short wave in people with Chronic Diseases and Knee Osteoarthritis, run by Irmandade da Santa Casa de Misericordia de Sao Paulo.
Trial summary
Study design: Randomized clinical trial. Objective: To evaluate the effect of PSW treatment in different doses and to compare to the control and placebo group. Background: Several forms of conservative treatment have been the focus of many recent studies in knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Chronic Diseases, Knee Osteoarthritis
- What is being tested?
- Pulsed short wave
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The female subjects were included if they were over 40 with knee primary grade II or III OA, based on Gupta et al radiographic criteria2, and joint or anterior knee pain for at least 3 months.
Who cannot join
- We excluded patients with a history of surgery or any invasive procedure of the affected knee, physical therapy for knee injuries or any medication that had changed in the last 3 months, other diseases changing function, and patients who presented any contraindication for PSW application, especially metallic implants, pacemakers, lack of sensitivity, or tumor.
About this study
Official title: Pulsed Short Wave in Females With Knee Osteoarthritis: A Multicenter, Randomized, Placebo-controlled Clinical Trial
Study design: Randomized clinical trial. Objective: To evaluate the effect of PSW treatment in different doses and to compare to the control and placebo group.
Background: Several forms of conservative treatment have been the focus of many recent studies in knee osteoarthritis (OA). Among these techniques, the application of pulsed short wave has been widely used, but the optimal dose and application time still have not been well established.
Read the detailed description
Methods: One hundred and twenty-one females (average ± sd age, 60 ± 9 years), with a diagnosis of knee OA were distributed randomly into 4 groups: 35 patients who did not receive any treatment (control), 23 patients in the placebo group, 32 patients in the low dose PSW group (14.5W, 19 minutes and 17KJ), and 31 patients in the high dose PSW group (14.5W, 38 minutes and 33KJ). An 11-point numerical pain rating scale (NPRS) and "Knee Osteoarthritis Outcome Score" (KOOS) were used to assess pain and function in 3 stages: initial evaluation (pre-treatment), immediately after post-treatment, and a 12-month follow up.
Results: The 4 groups were homogeneous prior to treatment with respect to demographics, pain, and functional scales data. We demonstrated the short-term effectiveness of the PSW at low or high doses in patients with knee OA. Both treatment groups showed significant improvement in pain and function when compared to the control and placebo groups (P<0.05). There were no differences between PSW doses, despite the fact that a low dose of PSW seems to be more effective in the long term.
Conclusion: The PSW is an effective method for pain relief, functionality, and quality of life improvement in females with knee osteoarthritis in the short-term. On the basis of our results, we recommend PSW application in the female population with knee OA. However, conclusions regarding the 12-month follow up should be analyzed carefully due to the high dropout rate.
- Conditions
- Chronic Diseases, Knee Osteoarthritis
- Being tested
- Pulsed short wave
- Keywords
- knee, osteoarthritis, physical therapy, pulsed short wave
- Medical subject headings
- Chronic Disease, Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed short waveDevice
The treatment was performed with 2 devices named Diatermed II (Carci, São Paulo, SP, Brazil), previously calibrated, carrying frequency of 27.12MHz, peak power of 250W, and pulse duration of 400µs. All these parameters are predetermined in the device according to the manufacturer. We used the maximum power provided by the machine in a pulsed form with a pulse frequency of 145Hz, resulting in a mean power of 14.5W.
| Study group | Role | What they receive |
|---|---|---|
| High dose PSW groups | Experimental | The treatment was performed with 2 devices named Diatermed II (Carci, São Paulo, SP, Brazil), previously calibrated, carrying frequency of 27.12MHz, peak power of 250W, and pulse duration of 400µs. All these parameters are predetermined in the device according to the manufacturer. We used the maximum power provided by the machine in a pulsed form with a pulse frequency of 145Hz, resulting in a mean power of 14.5W. These settings were based on the fact that applications with mean power below 20W minimize the thermal effects Receives: Device: Pulsed short wave |
| Placebo | Placebo comparator | A placebo group was also established, in which the PSW device was turned on but kept in stand-by mode during 19 minutes without any electrical current being applied in the patients Receives: Device: Pulsed short wave |
| Control | No intervention | The control group was composed of patients that were not submitted to any form of treatment and all patients were instructed to maintain their daily activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluation
The patients were evaluated in 3 phases: initial evaluation (pre-treatment), immediately after post-treatment, and a 12-month follow up. An 11-point numerical pain rating scale (NPRS) was used to measure pain during the last 2 days, where 0 corresponded to "no pain" and 10 corresponded to "worst imaginable pain".
Measured: 1 year follow up
Secondary outcomes (1)
Functional evaluation
We applied a validated "Knee Osteoarthritis Outcome Score" (KOOS) as a functional evaluation.28,29 The KOOS is a specific questionnaire for patients with knee injuries and OA. It consists of 5 subscales: symptoms, daily activities, pain, recreational function, and quality of life. The answers are based on reports from the last week, where 0 corresponded to "functional impairment" with exacerbated symptoms and 100 corresponded to "normal function" without symptoms. Each subscale was normalized and analyzed individually
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startAug 2006
- Primary completionMar 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseasesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thiago Yukio Fukuda, Irmandade da Santa Casa de Misericordia de Sao Paulo
- Investigators
- Thiago Y Fukuda, PhD, Principal investigator, Irmandade da Santa Casa de Misericórdia de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331174
- Sponsor's protocol ID
- 403/06
- Acronym
- PSW
- Status last verified
- Nov 2012
- First submitted
- 5 Apr 2011
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Fukuda TY, Ovanessian V, Alves da Cunha R, Jacob Filho Z, Cazarini Jr C, Rienzo FA, Centini AA. Pulsed Short Wave Effect in Pain and Function in patients with Knee Osteoarthritis. JARCET. 2008; 8(3):189-98.
Fukuda TY, Alves da Cunha R, Fukuda VO, Rienzo FA, Cazarini C Jr, Carvalho Nde A, Centini AA. Pulsed shortwave treatment in women with knee osteoarthritis: a multicenter, randomized, placebo-controlled clinical trial. Phys Ther. 2011 Jul;91(7):1009-17. doi: 10.2522/ptj.20100306. Epub 2011 Jun 3.
PubMed 21642511
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Short Wave in Females With Knee Osteoarthritis: A Multicenter, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01331174
- Acronym / sponsor ID
- PSW / 403/06
- Conditions
- Chronic Diseases, Knee Osteoarthritis
- Keywords
- knee, osteoarthritis, physical therapy, pulsed short wave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Irmandade da Santa Casa de Misericordia de Sao PauloUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study design: Randomized clinical trial. Objective: To evaluate the effect of PSW treatment in different doses and to compare to the control and placebo group.
Background: Several forms of conservative treatment have been the focus of many recent studies in knee osteoarthritis (OA). Among these techniques, the application of pulsed short wave has been widely used, but the optimal dose and application time still have not been well established.
Detailed description
Methods: One hundred and twenty-one females (average ± sd age, 60 ± 9 years), with a diagnosis of knee OA were distributed randomly into 4 groups: 35 patients who did not receive any treatment (control), 23 patients in the placebo group, 32 patients in the low dose PSW group (14.5W, 19 minutes and 17KJ), and 31 patients in the high dose PSW group (14.5W, 38 minutes and 33KJ). An 11-point numerical pain rating scale (NPRS) and "Knee Osteoarthritis Outcome Score" (KOOS) were used to assess pain and function in 3 stages: initial evaluation (pre-treatment), immediately after post-treatment, and a 12-month follow up.
Results: The 4 groups were homogeneous prior to treatment with respect to demographics, pain, and functional scales data. We demonstrated the short-term effectiveness of the PSW at low or high doses in patients with knee OA. Both treatment groups showed significant improvement in pain and function when compared to the control and placebo groups (P<0.05). There were no differences between PSW doses, despite the fact that a low dose of PSW seems to be more effective in the long term.
Conclusion: The PSW is an effective method for pain relief, functionality, and quality of life improvement in females with knee osteoarthritis in the short-term. On the basis of our results, we recommend PSW application in the female population with knee OA. However, conclusions regarding the 12-month follow up should be analyzed carefully due to the high dropout rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose PSW groups | Experimental | Device: Pulsed short waveThe treatment was performed with 2 devices named Diatermed II (Carci, São Paulo, SP, Brazil), previously calibrated, carrying frequency of 27.12MHz, peak power of 250W, and pulse duration of 400µs. All these parameters are predetermined in the device according to the manufacturer. We used the maximum power provided by the machine in a pulsed form with a pulse frequency of 145Hz, resulting in a mean power of 14.5W. These settings were based on the fact that applications with mean power below 20W minimize the thermal effects |
| Placebo | Placebo comparator | Device: Pulsed short waveA placebo group was also established, in which the PSW device was turned on but kept in stand-by mode during 19 minutes without any electrical current being applied in the patients |
| Control | No intervention | –The control group was composed of patients that were not submitted to any form of treatment and all patients were instructed to maintain their daily activities |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The female subjects were included if they were over 40 with knee primary grade II or III OA, based on Gupta et al radiographic criteria2, and joint or anterior knee pain for at least 3 months.
Key exclusion criteria (1 listed)
- We excluded patients with a history of surgery or any invasive procedure of the affected knee, physical therapy for knee injuries or any medication that had changed in the last 3 months, other diseases changing function, and patients who presented any contraindication for PSW application, especially metallic implants, pacemakers, lack of sensitivity, or tumor.
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 |
|---|---|---|
| Pulsed short waveThe treatment was performed with 2 devices named Diatermed II (Carci, São Paulo, SP, Brazil), previously calibrated, carrying frequency of 27.12MHz, peak power of 250W, and pulse duration of 400µs. All these parameters are predetermined in the device according to the manufacturer. We used the maximum power provided by the machine in a pulsed form with a pulse frequency of 145Hz, resulting in a mean power of 14.5W. | Device | High dose PSW groups, Placebo |
Primary outcome
Pain evaluation
Time frame: 1 year follow up
The patients were evaluated in 3 phases: initial evaluation (pre-treatment), immediately after post-treatment, and a 12-month follow up. An 11-point numerical pain rating scale (NPRS) was used to measure pain during the last 2 days, where 0 corresponded to "no pain" and 10 corresponded to "worst imaginable pain".
1 secondary outcome
Functional evaluation
Time frame: 1 year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Results publicationFukuda TY, Ovanessian V, Alves da Cunha R, Jacob Filho Z, Cazarini Jr C, Rienzo FA, Centini AA. Pulsed Short Wave Effect in Pain and Function in patients with Knee Osteoarthritis. JARCET. 2008; 8(3):189-98.
- Derived from this study: PubMed 21642511Fukuda TY, Alves da Cunha R, Fukuda VO, Rienzo FA, Cazarini C Jr, Carvalho Nde A, Centini AA. Pulsed shortwave treatment in women with knee osteoarthritis: a multicenter, randomized, placebo-controlled clinical trial. Phys Ther. 2011 Jul;91(7):1009-17. doi: 10.2522/ptj.20100306. Epub 2011 Jun 3.
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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.
Thiago Y Fukuda, PhD principal investigator
Irmandade da Santa Casa de Misericórdia de São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed short wave in people with Chronic Diseases and Knee Osteoarthritis, run by Irmandade da Santa Casa de Misericordia de Sao Paulo.
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 1 inclusion and 1 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 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain evaluation (time frame: 1 year follow up). 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 NCT01331174, which also lists 2 linked publications.
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 27 Nov 2012.