Knee Osteoarthritis Clinical Trial
— PSWOfficial 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.
Status | Completed |
Enrollment | 121 |
Est. completion date | December 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Irmandade da Santa Casa de Misericordia de Sao Paulo |
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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". | 1 year follow up | Yes |
Secondary | 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 | 1 year follow up | Yes |
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