Pulsed Short Wave in Females With Knee Osteoarthritis (PSW)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thiago Yukio Fukuda, Irmandade da Santa Casa de Misericordia de Sao Paulo
ClinicalTrials.gov Identifier:
NCT01331174
First received: April 5, 2011
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Chronic Diseases
Knee Osteoarthritis
Device: Pulsed short wave

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pulsed Short Wave in Females With Knee Osteoarthritis: A Multicenter, Randomized, Placebo-controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Irmandade da Santa Casa de Misericordia de Sao Paulo:

Primary Outcome Measures:
  • Pain evaluation [ Time Frame: 1 year follow up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 year follow up ] [ Designated as safety issue: Yes ]
    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


Enrollment: 121
Study Start Date: August 2006
Study Completion Date: December 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose PSW groups
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
Device: Pulsed short wave
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.
Placebo Comparator: Placebo
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
Device: Pulsed short wave
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.
No Intervention: Control
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331174

Sponsors and Collaborators
Irmandade da Santa Casa de Misericordia de Sao Paulo
Investigators
Principal Investigator: Thiago Y Fukuda, PhD Irmandade da Santa Casa de Misericórdia de São Paulo
  More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thiago Yukio Fukuda, PhD, Irmandade da Santa Casa de Misericordia de Sao Paulo
ClinicalTrials.gov Identifier: NCT01331174     History of Changes
Other Study ID Numbers: 403/06
Study First Received: April 5, 2011
Last Updated: November 26, 2012
Health Authority: Brazil: National Health Council, resolution 196/96

Keywords provided by Irmandade da Santa Casa de Misericordia de Sao Paulo:
knee
osteoarthritis
physical therapy
pulsed short wave

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Chronic Disease
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014