search
Back to results

Pulsed Short Wave in Females With Knee Osteoarthritis (PSW)

Primary Purpose

Chronic Diseases, Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulsed short wave
Sponsored by
Irmandade da Santa Casa de Misericordia de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Diseases focused on measuring knee, osteoarthritis, physical therapy, pulsed short wave

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    No Intervention

    Arm Label

    High dose PSW groups

    Placebo

    Control

    Arm Description

    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

    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

    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

    Outcomes

    Primary Outcome Measures

    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".

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    April 5, 2011
    Last Updated
    November 26, 2012
    Sponsor
    Irmandade da Santa Casa de Misericordia de Sao Paulo
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01331174
    Brief Title
    Pulsed Short Wave in Females With Knee Osteoarthritis
    Acronym
    PSW
    Official Title
    Pulsed Short Wave in Females With Knee Osteoarthritis: A Multicenter, Randomized, Placebo-controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Irmandade da Santa Casa de Misericordia de Sao Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Diseases, Knee Osteoarthritis
    Keywords
    knee, osteoarthritis, physical therapy, pulsed short wave

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    121 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High dose PSW groups
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    Pulsed short wave
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pain evaluation
    Description
    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".
    Time Frame
    1 year follow up
    Secondary Outcome Measure Information:
    Title
    Functional evaluation
    Description
    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
    Time Frame
    1 year follow up

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thiago Y Fukuda, PhD
    Organizational Affiliation
    Irmandade da Santa Casa de Misericórdia de São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    21642511
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Pulsed Short Wave in Females With Knee Osteoarthritis

    We'll reach out to this number within 24 hrs