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Trial registered on ANZCTR
Registration number
ACTRN12616000589482
Ethics application status
Approved
Date submitted
22/03/2016
Date registered
6/05/2016
Date last updated
5/07/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
Extracorporeal shock wave therapy (ESWT) and kinesiotherapy (KIN) on women with bilateral knee osteoarthritis
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Scientific title
The investigation of the effects of extracorporeal shock wave therapy (ESWT) and kinesiotherapy (KIN) on health status of women with bilateral knee osteoarthritis (OA): a randomised trial
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Secondary ID [1]
288817
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
knee pain
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osteoarthritis
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Condition category
Condition code
Musculoskeletal
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0
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Osteoarthritis
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Physical Medicine / Rehabilitation
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
ESWT - 1,000 pulses (during the first treatment), 1,500 (during the second and the third treatment), and 2,000 (during the fourth and the fifth treatment), respectively (pressure, 2.5 bar; frequency, 8 Hz; energy density, 0.4 mJ/mm2). ESWT - 1 treatment per week. Each treatment session will not exceed 10 minutes. Intervention will be delivered by a physiotherapist
KIN - 25 sessions of a physiotherapy program an hour a day, 5 days a week, for 5 weeks. Intervention will be delivered by a physiotherapist. The mode of delivery as face to face, The intervention will be provided individually. The Kinesiotherapy program: 1. Warm-up. 2. Stretching. 3. Strengthening. 4. Functional task-oriented training. 5. Endurance. 6. Cool down. Examples of exercises for all participants in Kin group: 1. Global flexion-extension of the lower limb. Alternated dorsal plantar flexion of the ankles. 2. Stretching of the hamstrings. 3. Isometric knee extensors: flex 0 degrees. Isometric knee extensors: flex 60 degrees. Isometric hamstrings: flex 60 degrees. Concentric-eccentric hip abductors. 4. Knee extensor strengthening while standing with Thera-Band. Controlled bilateral knee flexion-extension while standing . Climbing on a platform or a flight of stairs. Walking in place, with a large amplitude of hip and knee flexion and upper-limb movements. 5. Stationary cycling. 6. Ice for quadriceps, hamstrings, and calf. Intervention will be administered in physiotherapy department, Log of sessions attended will be maintained. Participants will never receive both intervention, two separate groups will receive only one intervention - ESWT or KIN.
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Intervention code [1]
294270
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Treatment: Devices
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Intervention code [2]
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Rehabilitation
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Comparator / control treatment
KiN - control
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Control group
Active
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Outcomes
Primary outcome [1]
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the Western Ontario and McMaster Universities Questionnaire (WOMAC) Osteoarthritis Index
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Assessment method [1]
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Timepoint [1]
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before treatment starts
at 5 weeks after randomisation
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Secondary outcome [1]
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knee pain assessed using a 10 cm Visual Analogue Scale (VAS)
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Assessment method [1]
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Timepoint [1]
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baseline and 5 weeks after treatment starts
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Secondary outcome [2]
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the Six-Minute Walk Test (6-MWT) was performed to evaluate functional exercise capacity in a 100 m-long indoor hallway free of obstacles
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Assessment method [2]
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Timepoint [2]
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baseline and 5 weeks after treatment starts,
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Secondary outcome [3]
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knee flexion range of painless movement. This outcome will be assessed using goniometer (MSD Europe bvba, Londerzeel, Belgium)
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Assessment method [3]
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Timepoint [3]
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baseline and 5 weeks after treatment starts
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Secondary outcome [4]
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knee extension range of painless movement. This outcome will be assessed using goniometer (MSD Europe bvba, Londerzeel, Belgium)
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Assessment method [4]
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Timepoint [4]
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baseline and 5 weeks after treatment starts
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Eligibility
Key inclusion criteria
female gender, minimum age of 40, ability to perform physical exercises, not currently receiving any physical therapy treatments for the knee OA condition, medication compliance (all patients were taking glucocorticoids at the time of the study), and the diagnosis of bilateral knee OA according to the American College of Rheumatology criteria
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Minimum age
40
Years
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Maximum age
75
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
unilateral knee OA, neurological disorders, cognitive limitations or history of cardiovascular, pulmonary or endocrinology disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
2/11/2015
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Date of last participant enrolment
Anticipated
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Actual
21/03/2016
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Date of last data collection
Anticipated
20/06/2016
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Actual
20/06/2016
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment outside Australia
Country [1]
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Poland
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State/province [1]
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Silesia
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Holycross College
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Address [1]
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51, Mielczarskiego Str.
25-709 Kielce
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Country [1]
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Poland
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Primary sponsor type
University
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Name
Holycross College
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Address
51, Mielczarskiego Str.
25-709 Kielce
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Country
Poland
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Holycross College Ethics Committee
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Ethics committee address [1]
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51, Mielczarskiego Str.
25-709 Kielce
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Ethics committee country [1]
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Poland
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Date submitted for ethics approval [1]
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01/10/2015
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Approval date [1]
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22/10/2015
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Ethics approval number [1]
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11/152014KB
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Summary
Brief summary
Despite the advances in treatment there is lack of comparative studies on the effects of ESWT and other treatments such as KIN in patients with knee OA.
Objectives of Study: to compare the effects of ESWT and KIN protocol on perceived health evaluated by the Western Ontario and McMaster Universities Questionnaire (WOMAC) Osteoarthritis Index, on severity of knee pain by Visual Analogue Scale (VAS), on Range of Motion (ROM) of the knees and also on functional exercise capacity by the Six-Minute Walk Test (6-MWT) physical function, decreased exercise capacity).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Pawel Lizis
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Address
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Pawel Lizis
Holycross College
51, Mielczarskiego Str.
25-709 Kielce
Wojciech Kobza
Bielski College named after Tyszkiewicz
12, Nadbrzezna Str.
43-300 Bielsko-Biala
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Country
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Poland
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Phone
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+48663793834
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Pawel Lizis
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Address
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Pawel Lizis
Holycross College
51, Mielczarskiego Str.
25-709 Kielce
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Country
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Poland
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Phone
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+48663793834
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Pawel Lizis
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Address
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Pawel Lizis
Holycross College
51, Mielczarskiego Str.
25-709 Kielce
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Country
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Poland
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Phone
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+48663793834
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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