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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Ireland1 site
  • Mater Misericodriae University Hospital

    Dublin, Dublin, 7

Other trials in Ireland

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.

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 groups in NCT00726492
Study groupRoleWhat they receive
CSWD + HydroExperimentalContinuous short wave diathermy and hydrotherapy
Receives: Other: Continuous short wave diathermy (CSWD); Other: Hydrotherapy
Hydro aloneExperimentalHydrotherapy alone
Receives: Other: Hydrotherapy
CSWD aloneExperimentalContinuous short wave diathermy alone
Receives: Other: Continuous short wave diathermy (CSWD)
ControlNo interventionNo treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Six-minute walk test

    Measured: 4 and 8 weeks

Secondary outcomes (4)
  1. Visual analogue pain scale (10 cm line)

    Measured: 4 and 8 weeks

  2. Knee range of motion

    Measured: 4 and 8 weeks

  3. Arthritis Impact Measurement Scale 2 (AIMS 2)

    Measured: 4 and 8 weeks

  4. 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.

  1. First posted1 Aug 2008 (estimated)
  2. Study startJun 2001
  3. Primary completionApr 2003
  4. Study completionApr 2003

Resources

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)
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

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.

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