- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00726492
An Examination of the Value of Shortwave Diathermy and Hydrotherapy for Patients With Osteoarthritis of Their Knees
A Randomised Controlled Trial Evaluating the Effects of Shortwave Diathermy and Hydrotherapy for Patients With Osteoarthritis of Their Knees
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteoarthritis is a common disabling disorder increasing in prevalence with advancing age (Blixen and Kippes, 1999). As there is a rapid increase in the percentage of people over 55 years in Western countries (Okma-Keulen and Hopman-Rock, 2001) it has become increasingly important to address issues which relate to older people. In 2010, the projected percentage of the population aged 60 years or older in Europe will be approximately 25%. The increased incidence of arthritis among older people, which is a significant health care problem today, is set to become an even greater concern in the coming years (Reginster, 2002). Rheumatic diseases are a huge encumbrance on the health care systems of countries worldwide and account for significant disability, lost productivity and reduction in quality of life (Sangha, 2000). The burden of disease relates not only to its prevalence but also to the cost of the disease to the health care system of the country, these costs include direct costs, such as the costs associated with drugs, medical care, hospitals, research, pensions and benefits and indirect costs, such as premature mortality and chronic disability (Reginster, 2002). Neither census statistics nor statistics from the Department of Health and Children revealed the true prevalence of osteoarthritis in Ireland. A search was also carried out using the Hospital Inpatient Enquiry (HIPE) system of The Economic and Social Research Institute of Ireland (ESRI) which likewise did not reveal the frequency of osteoarthritis in the population.
Osteoarthritis is characterised by progressive loss of articular cartilage, appositional subchondral bone development and osteophyte formation at the joint margins. The resulting pain, stiffness and functional limitations (Jakobsson and Hallberb, 2002) lead to diminished quality of life. The knee is a particularly common site of involvement in osteoarthritis. Osteoarthritic knee pain has been found to be associated with poor perceived health and significant disability, while psychological distress strongly associates with both pain and disability (O'Reilly et al, 1998; Sangha, 2000). Restricted knee joint mobility, in particular flexion appears to be an important determinant of disability in patients with osteoarthritis (Steultjens et al, 2000). Minor et al (1999) noted that lower extremity impairments in older adults have been linked to the reduced ability to use public transportation, climb stairs, perform household chores, shop and engage in leisure activities. Similarly van Barr (1998) noted that disability in patients with lower limb osteoarthritis is significantly related to pain and joint range of motion. Due to the chronic nature of osteoarthritis, physical modalities, lifestyle modification and patient self-management in terms of education and exercise are considered important approaches to treatment (Sangha, 2000).
Physiotherapists have an important role to play in the clinical management of osteoarthritis (Green et al, 1993) however, the effect of their involvement has rarely been assessed in terms of randomised controlled trials. Chard et al (2000) examined the research output in relation to a number of physiotherapy interventions available to patients with osteoarthritis of their knees and established that between 1950 to 1998 only 60 research articles were published, the majority of which occurred between 1985 and 1998. Advice (Maurer et al, 1999; Manek and Lane, 2000) and exercise (Puett and Griffin, 1994; Clarke, 1999; O'Reilly et al, 1999) have been clearly identified as beneficial in terms of relieving the impairments experienced by individuals with knee osteoarthritis. Indeed there is a some evidence supporting the use of a number of physiotherapy interventions including hydrotherapy (Ahern et al, 1995; Norton et al 1997; Alexander et al, 2001) and continuous short-wave diathermy (CSWD) (Wright, 1964; Lankhorst et al, 1982) for the treatment of knee osteoarthritis but there are difficulties regarding the design of many of these studies thus undermining the conclusions that have been drawn. This study presents the results of a randomised controlled factorial trial (Polger and Thomas, 2000) designed to examine hydrotherapy and/or continuous short wave diathermy (CSWD) for patients with knee osteoarthritis while also examining the perceptions of patients participating in a physiotherapy programme.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dublin, Ireland, 7
- Mater Misericodriae University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients had to have a documented diagnosis of osteoarthritis of their knees.
- Patients had to be between 50 and 70 years inclusive.
- Patients had to have X-ray evidence of osteoarthritis of their knees.
Exclusion Criteria:
- Patients with another rheumatological condition other than osteoarthritis.
- Patients who were unable to understand the concepts, assessment and treatment involved.
- Patients who had received a cortisone injection into the knee in the previous 30 days.
- Patients for whom CSWD or hydrotherapy has been contraindicated.
- Patients who have had either CSWD or hydrotherapy in the past.
- Patients who had undergone a surgical procedure on either lower limb in the past 6 months.
- Patients who were receiving other physiotherapy treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No treatment
|
|
|
Experimental: CSWD + Hydro
Continuous short wave diathermy and hydrotherapy
|
CSWD applied twice a week for 4 weeks
Hydrotherapy (exercise in water) attended twice a week for 4 weeks
|
|
Experimental: Hydro alone
Hydrotherapy alone
|
Hydrotherapy (exercise in water) attended twice a week for 4 weeks
|
|
Experimental: CSWD alone
Continuous short wave diathermy alone
|
CSWD applied twice a week for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Six-minute walk test
Time Frame: 4 and 8 weeks
|
4 and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual analogue pain scale (10 cm line)
Time Frame: 4 and 8 weeks
|
4 and 8 weeks
|
|
Knee range of motion
Time Frame: 4 and 8 weeks
|
4 and 8 weeks
|
|
Arthritis Impact Measurement Scale 2 (AIMS 2)
Time Frame: 4 and 8 weeks
|
4 and 8 weeks
|
|
Patient interview
Time Frame: 4 and 8 weeks
|
4 and 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tara Cusack, MMedSc PhD, University College Dublin
- Principal Investigator: Conor J McCarthy, MD, Mater Misericordiae University Hospital
- Principal Investigator: Leslie Daly, BSc MSc PhD, University College Dublin
- Principal Investigator: Mary F McAteer, MEd PhD, University College Dublin
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1/378/664
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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