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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
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
Secondary ID [1] 288817 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee pain 298418 0
osteoarthritis 298419 0
Condition category
Condition code
Musculoskeletal 298251 298251 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 298252 298252 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 294270 0
Treatment: Devices
Intervention code [2] 294575 0
Rehabilitation
Comparator / control treatment
KiN - control
Control group
Active

Outcomes
Primary outcome [1] 297739 0
the Western Ontario and McMaster Universities Questionnaire (WOMAC) Osteoarthritis Index
Timepoint [1] 297739 0
before treatment starts
at 5 weeks after randomisation
Secondary outcome [1] 322112 0
knee pain assessed using a 10 cm Visual Analogue Scale (VAS)
Timepoint [1] 322112 0
baseline and 5 weeks after treatment starts
Secondary outcome [2] 322114 0
the Six-Minute Walk Test (6-MWT) was performed to evaluate functional exercise capacity in a 100 m-long indoor hallway free of obstacles
Timepoint [2] 322114 0
baseline and 5 weeks after treatment starts,
Secondary outcome [3] 323293 0
knee flexion range of painless movement. This outcome will be assessed using goniometer (MSD Europe bvba, Londerzeel, Belgium)
Timepoint [3] 323293 0
baseline and 5 weeks after treatment starts
Secondary outcome [4] 323294 0
knee extension range of painless movement. This outcome will be assessed using goniometer (MSD Europe bvba, Londerzeel, Belgium)
Timepoint [4] 323294 0
baseline and 5 weeks after treatment starts

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
Minimum age
40 Years
Maximum age
75 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
unilateral knee OA, neurological disorders, cognitive limitations or history of cardiovascular, pulmonary or endocrinology disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7721 0
Poland
State/province [1] 7721 0
Silesia

Funding & Sponsors
Funding source category [1] 293176 0
University
Name [1] 293176 0
Holycross College
Address [1] 293176 0
51, Mielczarskiego Str.
25-709 Kielce
Country [1] 293176 0
Poland
Primary sponsor type
University
Name
Holycross College
Address
51, Mielczarskiego Str.
25-709 Kielce
Country
Poland
Secondary sponsor category [1] 291970 0
None
Name [1] 291970 0
Address [1] 291970 0
Country [1] 291970 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294667 0
The Holycross College Ethics Committee
Ethics committee address [1] 294667 0
51, Mielczarskiego Str.
25-709 Kielce
Ethics committee country [1] 294667 0
Poland
Date submitted for ethics approval [1] 294667 0
01/10/2015
Approval date [1] 294667 0
22/10/2015
Ethics approval number [1] 294667 0
11/152014KB

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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64562 0
Dr Pawel Lizis
Address 64562 0
Pawel Lizis
Holycross College
51, Mielczarskiego Str.
25-709 Kielce

Wojciech Kobza
Bielski College named after Tyszkiewicz
12, Nadbrzezna Str.
43-300 Bielsko-Biala
Country 64562 0
Poland
Phone 64562 0
+48663793834
Fax 64562 0
Email 64562 0
pawel_lizis@poczta.onet.pl
Contact person for public queries
Name 64563 0
Dr Pawel Lizis
Address 64563 0
Pawel Lizis
Holycross College
51, Mielczarskiego Str.
25-709 Kielce
Country 64563 0
Poland
Phone 64563 0
+48663793834
Fax 64563 0
Email 64563 0
pawel_lizis@poczta.onet.pl
Contact person for scientific queries
Name 64564 0
Dr Pawel Lizis
Address 64564 0
Pawel Lizis
Holycross College
51, Mielczarskiego Str.
25-709 Kielce
Country 64564 0
Poland
Phone 64564 0
+48663793834
Fax 64564 0
Email 64564 0
pawel_lizis@poczta.onet.pl

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary