Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000489897
Ethics application status
Approved
Date submitted
27/11/2019
Date registered
27/04/2021
Date last updated
27/04/2021
Date data sharing statement initially provided
27/04/2021
Date results information initially provided
27/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a 12 month physiotherapy program on hip joint structure and function in patients with hip osteoarthritis
Scientific title
The effect of a 12 month physiotherapy program on hip joint structure and function in patients with hip osteoarthritis
Secondary ID [1] 299154 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 314218 0
Hip joint function 314220 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312580 312580 0 0
Physiotherapy
Musculoskeletal 312581 312581 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention studied is a long-term physiotherapy program.
The intervention is delivered by physiotherapist with minimum 5 years’ experience.
The intervention is provided individually and all treatment sessions are therapist-supervised.
The duration of the whole intervention is 12 months. The intervention is delivered in three 3-weeks cycles consisting of 5 therapeutic sessions per week. Each session lasts 140 minutes. The first and second cycle are followed by a 5-month interval.
The exercise session consists of hip joint traction followed by hip suspension exercises, lower extremities muscle strengthening and proprioception training.
Additionally, before each session, transcutaneous electrical nerve stimulation (TENS) is administered for 30 minutes. Electrical stimulation is delivered using two disposable, 60 x 60 mm, carbon electrodes. TENS setting is in a conventional mode, emitting a pulsed biphasic, symmetrical rectangular wave with a frequency of 100 Hz and a pulse duration of 100 µs. The intensity is set according to the participant’s tolerance then gradually increased and limited by the perception of strong but comfortable tingling.
The intervention occurs at the rehabilitation outpatient clinic.
Intervention code [1] 315428 0
Treatment: Other
Intervention code [2] 315429 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321236 0
The primary outcome for the study is hip-related functional evaluation performed using Hip dysfunction and Osteoarthritis Outcome Score (HOOS).
Timepoint [1] 321236 0
The self-reported questionnaire assessment is performed four times, at the baseline and after each cycle of physiotherapy.
Primary outcome [2] 324280 0
Another primary outcome for the study is hip-related functional evaluation performed using The Osteoarthritis Research Society International core set of performance-based tests of physical function for use in people with hip and knee osteoarthritis (30-second Chair Stand Test (30s CST), 40-m Fast-paced Walk Test (40m FPWT) and Stair Climb Test (SCT)). This is a composite primary outcome.
Timepoint [2] 324280 0
The assessor-observed performance-based tests evaluation is performed four times, at the baseline and after each cycle of physiotherapy.
Secondary outcome [1] 374417 0
The secondary outcome for the study is magnetic resonance assessment of the hip joint. Parameters are analyzed using Scoring Hip Osteoarthritis with MRI (SHOMRI) evaluation system.
Timepoint [1] 374417 0
The MRI measurement is performed twice, at the baseline and after the 12-month intervention.

Eligibility
Key inclusion criteria
Patients with hip osteoarthritis fulfilling American College of Rheumatology (ACR) classification criteria.
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications for MRI imaging, physiotherapeutic treatment or physical activity; systemic arthritic conditions or diseases that could significantly affect the condition of the hip joint and the patient's functional capabilities; prior hip surgery or lower extremity joint replacement; intra-articular corticosteroid injection or oral steroid or NSAID chronic use within six months; viscosupplementation within six months; prior cerebral vascular accident or other neurological disorders affected sensorimotor functions; history of myocardial infarction; history of cancer; general poor health status;

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/03/2016
Date of last participant enrolment
Anticipated
Actual
26/02/2018
Date of last data collection
Anticipated
Actual
20/03/2019
Sample size
Target
50
Accrual to date
Final
37
Recruitment outside Australia
Country [1] 21826 0
Poland
State/province [1] 21826 0

Funding & Sponsors
Funding source category [1] 303695 0
University
Name [1] 303695 0
Medical University of Warsaw
Country [1] 303695 0
Poland
Primary sponsor type
Individual
Name
Andrzej Cieszanowski
Address
2nd Department of Clinical Radiology, Medical University of Warsaw
1a Stefana Banacha St., 02-097 Warsaw, Poland
Country
Poland
Secondary sponsor category [1] 304642 0
Individual
Name [1] 304642 0
Piotr Palczewski
Address [1] 304642 0
1st Department of Clinical Radiology, Medical University of Warsaw
5 Chalubinskiego St., 02-004 Warsaw, Poland
Country [1] 304642 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304219 0
Committee on Bioethics of the Medical University of Warsaw
Ethics committee address [1] 304219 0
61 Zwirki i Wigury St., 02-091 Warsaw, Poland
Ethics committee country [1] 304219 0
Poland
Date submitted for ethics approval [1] 304219 0
Approval date [1] 304219 0
07/10/2014
Ethics approval number [1] 304219 0
KB/189/2014

Summary
Brief summary
The main purpose of the study is to investigate the effect a long term exercise program has on the hip joint structure and function in patients with hip osteoarthritis completing long-term land-based physiotherapy program. In addition the study aims to investigates the correlation between MRI data and functional evaluation of the hip joint.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96182 0
Ms Agnieszka Lewinska
Address 96182 0
2nd Department of Clinical Radiology, Medical University of Warsaw
1a Stefana Banacha St., 02-097 Warsaw, Poland
Country 96182 0
Poland
Phone 96182 0
+48225992300
Fax 96182 0
Email 96182 0
agnieszka.lewinska@wum.edu.pl
Contact person for public queries
Name 96183 0
Ms Agnieszka Lewinska
Address 96183 0
2nd Department of Clinical Radiology, Medical University of Warsaw
1a Stefana Banacha St., 02-097 Warsaw, Poland
Country 96183 0
Poland
Phone 96183 0
+48225992300
Fax 96183 0
Email 96183 0
agnieszka.lewinska@wum.edu.pl
Contact person for scientific queries
Name 96184 0
Ms Agnieszka Lewinska
Address 96184 0
2nd Department of Clinical Radiology, Medical University of Warsaw
1a Stefana Banacha St., 02-097 Warsaw, Poland
Country 96184 0
Poland
Phone 96184 0
+48225992300
Fax 96184 0
Email 96184 0
agnieszka.lewinska@wum.edu.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4478Ethical approval    378281-(Uploaded-02-09-2019-02-25-07)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 378281-(Uploaded-27-11-2019-04-16-45)-Basic results summary.docx

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAssessing the impact of a long-term physiotherapy program on hip function in patients with osteoarthritis: The role of patient-reported and assessor-observed outcome measures.2022https://dx.doi.org/10.5114/ms.2022.122388
EmbaseThe use of scoring hip osteoarthritis with mri as an assessment tool for physiotherapeutic treatment in patients with osteoarthritis of the hip.2022https://dx.doi.org/10.3390/jcm11010017
N.B. These documents automatically identified may not have been verified by the study sponsor.