Knee OsteoarthritisNCT00726492
An Examination of the Value of Shortwave Diathermy and Hydrotherapy for Patients With Osteoarthritis of Their Knees
A study testing Continuous short wave diathermy (CSWD) and Hydrotherapy in people with Knee Osteoarthritis, run by University College Dublin at 1 site in Ireland.
Trial summary
Osteoarthritis, a common disorder increasing in prevalence with advancing age, is particularly debilitating when the knees are affected. This study examined the value of hydrotherapy (exercise in water) and continuous short-wave diathermy (an electrical deep heat treatment) for the relief of osteoarthritic symptoms. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Continuous short wave diathermy (CSWD) and Hydrotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteIreland
- Study dates
- Jun 2001to Apr 2003
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial Evaluating the Effects of Shortwave Diathermy and Hydrotherapy for Patients With Osteoarthritis of Their Knees
Osteoarthritis, a common disorder increasing in prevalence with advancing age, is particularly debilitating when the knees are affected. This study examined the value of hydrotherapy (exercise in water) and continuous short-wave diathermy (an electrical deep heat treatment) for the relief of osteoarthritic symptoms.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Continuous short wave diathermy (CSWD), Hydrotherapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous short wave diathermy (CSWD)Other
CSWD applied twice a week for 4 weeks
HydrotherapyOther
Hydrotherapy (exercise in water) attended twice a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| CSWD + Hydro | Experimental | Continuous short wave diathermy and hydrotherapy Receives: Other: Continuous short wave diathermy (CSWD); Other: Hydrotherapy |
| Hydro alone | Experimental | Hydrotherapy alone Receives: Other: Hydrotherapy |
| CSWD alone | Experimental | Continuous short wave diathermy alone Receives: Other: Continuous short wave diathermy (CSWD) |
| Control | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test
Measured: 4 and 8 weeks
Secondary outcomes (4)
Visual analogue pain scale (10 cm line)
Measured: 4 and 8 weeks
Knee range of motion
Measured: 4 and 8 weeks
Arthritis Impact Measurement Scale 2 (AIMS 2)
Measured: 4 and 8 weeks
Patient interview
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJun 2001
- Primary completionApr 2003
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Investigators
- Tara Cusack, MMedSc PhD, Principal investigator, University College DublinConor J McCarthy, MD, Principal investigator, Mater Misericordiae University HospitalLeslie Daly, BSc MSc PhD, Principal investigator, University College DublinMary F McAteer, MEd PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726492
- Sponsor's protocol ID
- 1/378/664
- Status last verified
- Jul 2008
- First submitted
- 29 Jul 2008
- Last updated
- 1 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Evaluating the Effects of Shortwave Diathermy and Hydrotherapy for Patients With Osteoarthritis of Their Knees
- ClinicalTrials.gov ID
- NCT00726492
- Acronym / sponsor ID
- 1/378/664
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 1 Aug 2008 (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.
Osteoarthritis, a common disorder increasing in prevalence with advancing age, is particularly debilitating when the knees are affected. This study examined the value of hydrotherapy (exercise in water) and continuous short-wave diathermy (an electrical deep heat treatment) for the relief of osteoarthritic symptoms.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CSWD + Hydro | Experimental | Other: Continuous short wave diathermy (CSWD), Other: HydrotherapyContinuous short wave diathermy and hydrotherapy |
| Hydro alone | Experimental | Other: HydrotherapyHydrotherapy alone |
| CSWD alone | Experimental | Other: Continuous short wave diathermy (CSWD)Continuous short wave diathermy alone |
| Control | No intervention | –No treatment |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Continuous short wave diathermy (CSWD)CSWD applied twice a week for 4 weeks | Other | CSWD + Hydro, CSWD alone |
| HydrotherapyHydrotherapy (exercise in water) attended twice a week for 4 weeks | Other | CSWD + Hydro, Hydro alone |
Primary outcome
Six-minute walk test
Time frame: 4 and 8 weeks
4 secondary outcomes
Visual analogue pain scale (10 cm line)
Time frame: 4 and 8 weeks
Knee range of motion
Time frame: 4 and 8 weeks
Arthritis Impact Measurement Scale 2 (AIMS 2)
Time frame: 4 and 8 weeks
Patient interview
Time frame: 4 and 8 weeks
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 1 Aug 2008.
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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.
Tara Cusack, MMedSc PhD principal investigator
University College Dublin
Conor J McCarthy, MD principal investigator
Mater Misericordiae University Hospital
Leslie Daly, BSc MSc PhD principal investigator
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous short wave diathermy (CSWD) and Hydrotherapy in people with Knee Osteoarthritis, run by University College Dublin at 1 site in Ireland.
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 3 inclusion and 7 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 1 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Six-minute walk test (time frame: 4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2008; AzTrials last refreshed its copy on 8 Nov 2026.