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Trial registered on ANZCTR


Registration number
ACTRN12622000573752
Ethics application status
Approved
Date submitted
7/12/2021
Date registered
14/04/2022
Date last updated
3/04/2024
Date data sharing statement initially provided
14/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional assessment of orthopedic patients undergoing selected methods of physiotherapy.
Scientific title
Functional assessment of orthopedic patients undergoing selected methods of physiotherapy.
Secondary ID [1] 305973 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 324576 0
knee replacement 324577 0
anterior cruciate ligament injury 324578 0
meniscus repair 324579 0
Carpal Tunnel Syndrome 324580 0
Dupuytren's disease 324581 0
soft tissue injury 324582 0
myofascial pain syndrome 324583 0
Condition category
Condition code
Injuries and Accidents 322042 322042 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 322043 322043 0 0
Physiotherapy
Musculoskeletal 322044 322044 0 0
Osteoarthritis
Musculoskeletal 322045 322045 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Due to the continuity of the musculoskeletal system and the myofascial system, each patient will be examined by a physiotherapist before each individual physiotherapeutic session, and the therapy will be carried out individually within the dysfunctional elements of the musculoskeletal system (including the myofascial system). Participants will be allocated to the various, available interventions on the basis of a test (functional and palpation assessment) carried out by a physiotherapist.

Dysfunctional elements of the locomotor system (including the fascial system) of the study participants will be subjected to selected, personalized interventions:
1. Manual therapy:
a) soft tissue therapy: targeted myofascial therapy (targeting: deep fascia of muscles and/or intermuscular furrows and/or trigger points and/or densification or fibrosis points/regions of deep and superficial fascia) and/or
b) joint mobilisation depending on the treatment plan co-designed with the treating physiotherapist.
Treatment will be targeted to areas with structural changes.
2. Exercises:
a) patterned movement exercises (using regional and global movement patterns) and/or
b) resistance exercises (using manual or instrument-generated resistance).
3. Physical therapy (targeting: cryotherapy and/or electrostimulation).

The frequency/duration of the intervention: 2 hours of consultation every 5 days for 2-6 months. The mode of administration: one-on-one face-to-face consultation. The intervention will be performed by a physiotherapist with 15 years of experience. Session attendance checklists will be conducted.
Intervention code [1] 322364 0
Rehabilitation
Intervention code [2] 322365 0
Treatment: Other
Comparator / control treatment
Active: including standard care (standard care differs from the intervention practices described above lack of an individual physiotherapy plan - it will be a general, routine physiotherapy in patients with a given disease entity / postoperative condition (patients with: knee joint degeneration, knee arthroplasty, knee ligament and / or meniscus reconstruction procedures, Carpal Tunnel Syndrome, Dupuytren's contracture respectively) or placebo: inactive or sham treatment (application of manual soft tissues therapy in regions of the locomotor system devoid of structural changes).
Control group
Active

Outcomes
Primary outcome [1] 329800 0
Muscle activity assessed by surface electromyography (sEMG).
Timepoint [1] 329800 0
Baseline line (immediately before the start of physiotherapy), 1 week after the end of physiotherapy, in addition: in surgically treated patients: before surgery, and in conservatively treated patients - 12 months after the end of physiotherapy.
Primary outcome [2] 329806 0
Mechanical properties of soft tissues will be assessed by the algometer - myotonometry (collected four different biomechanical parameters: tone [Hz] = F, stiffness [N/m] = S, elasticity (log decrement) = D, and relaxation time [ms] = R).
Timepoint [2] 329806 0
Baseline line (immediately before the start of physiotherapy), 1 week after the end of physiotherapy, in addition: in surgically treated patients: before surgery, and in conservatively treated patients - 12 months after the end of physiotherapy.
Primary outcome [3] 329807 0
Proprioception (joint position sense, JPS) will be assessed by the smartphone and electrogoniometer.
Timepoint [3] 329807 0
Baseline line (immediately before the start of physiotherapy), 1 week after the end of physiotherapy, in addition: in surgically treated patients: before surgery, and in conservatively treated patients - 12 months after the end of physiotherapy.
Secondary outcome [1] 403892 0
Pain level will (composite outcome) be assessed by: Visual Analog Scale for Pain (VAS Pain), Chronic Pain Grade Scale (CPGS), Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP).
Timepoint [1] 403892 0
Baseline line (immediately before the start of physiotherapy), 1 week after the end of physiotherapy, in addition: in surgically treated patients: before surgery, and in conservatively treated patients - 12 months after the end of physiotherapy.
Secondary outcome [2] 403893 0
The cross-section of the selected muscles (composite secondary outcome) will be performed using ultrasound examination (USG).
Timepoint [2] 403893 0
Baseline line (immediately before the start of physiotherapy), 1 week after the end of physiotherapy, in addition: in surgically treated patients: before surgery, and in conservatively treated patients - 12 months after the end of physiotherapy.
Secondary outcome [3] 403958 0
The knee function assessed by KOOS (Knee injury and Osteoarthritis Outcome Score).
Timepoint [3] 403958 0
Baseline line (immediately before the start of physiotherapy), 1 week after the end of physiotherapy, in addition: in surgically treated patients: before surgery, and in conservatively treated patients - 12 months after the end of physiotherapy.
Secondary outcome [4] 406896 0
The knee function assessed by OKS (Oxford Knee Score).
Timepoint [4] 406896 0
Baseline line (immediately before the start of physiotherapy), 1 week after the end of physiotherapy, in addition: in surgically treated patients: before surgery, and in conservatively treated patients - 12 months after the end of physiotherapy.
Secondary outcome [5] 406897 0
Carpal tunnel syndrome severity assessed by BCTQ (Boston Carpal Tunnel Syndrome Questionnaire).
Timepoint [5] 406897 0
Baseline line (immediately before the start of physiotherapy), 1 week after the end of physiotherapy, in addition: in surgically treated patients: before surgery, and in conservatively treated patients - 12 months after the end of physiotherapy.
Secondary outcome [6] 406898 0
The function of upper limb assessed by DASH (Disabilities of the Arm, Shoulder and Hand).
Timepoint [6] 406898 0
Baseline line (immediately before the start of physiotherapy), 1 week after the end of physiotherapy, in addition: in surgically treated patients: before surgery, and in conservatively treated patients - 12 months after the end of physiotherapy.
Secondary outcome [7] 406899 0
The movement patterns quality assessed by FMS (Functional Movement Screen).
Timepoint [7] 406899 0
Baseline line (immediately before the start of physiotherapy), 1 week after the end of physiotherapy, in addition: in surgically treated patients: before surgery, and in conservatively treated patients - 12 months after the end of physiotherapy.
Secondary outcome [8] 408654 0
The cross-section of the median nerve will be performed using ultrasound examination (USG).
Timepoint [8] 408654 0
Baseline line (immediately before the start of physiotherapy), 1 week after the end of physiotherapy, in addition: in surgically treated patients: before surgery, and in conservatively treated patients - 12 months after the end of physiotherapy.

Eligibility
Key inclusion criteria
Occurrence in the patient:
- Carpal Tunnel Syndrome detected by objective ultrasound and/or EMG examination;
- Dupuytren's contracture in at least one finger of the hand;
- a knee osteoarthritis visible on imaging (X-ray and/or MRI);
- ligaments injuries, a meniscus tear of the knee joint
qualified for surgery.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Occurrence in the patient:
- rheumatoid and / or neurological diseases;
- advanced pathological changes in the spine;
- advanced pathological changes in the foot and / or hip joints;
- advanced pathological changes within the joints of the shoulder and elbow complexes;
- permanent damage to the locomotor system.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Before starting the intervention, patients will be randomly allocated to the experimental or placebo group by an independent researcher using the sealed envelopes method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedure like sealed envelopes method.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
2/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
115
Final
Recruitment outside Australia
Country [1] 24374 0
Poland
State/province [1] 24374 0

Funding & Sponsors
Funding source category [1] 310313 0
University
Name [1] 310313 0
Jagiellonian University Medical College
Country [1] 310313 0
Poland
Funding source category [2] 310323 0
Hospital
Name [2] 310323 0
University Hospital in Krakow, Department of Orthopedics and Traumatology
Country [2] 310323 0
Poland
Primary sponsor type
University
Name
Jagiellonian University Medical College, Department of Orthopedics and Physiotherapy
Address
Jakubowskiego 2 Str,
Krakow 30-688
Country
Poland
Secondary sponsor category [1] 311446 0
None
Name [1] 311446 0
Address [1] 311446 0
Country [1] 311446 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309977 0
the Bioethics Committee at the Jagiellonian University Medical College in Krakow, Poland
Ethics committee address [1] 309977 0
Skawinska 8 Str
Krakow 31-066
Ethics committee country [1] 309977 0
Poland
Date submitted for ethics approval [1] 309977 0
14/02/2019
Approval date [1] 309977 0
28/02/2019
Ethics approval number [1] 309977 0
1072.6120.59.2019

Summary
Brief summary
The purpose of the study will be to objectively assess the effectiveness of various methods of physiotherapy, individually customized for each patient, appropriate for a given group of patients. The following will be assessed: muscle activity, proprioception, mechanical properties of soft tissues, pain level and the function of the musculoskeletal system.
Participants will be undergo 2-6-month (depending on the group of patients and the treatment method used: conservative or surgical) physiotherapy (one-on-one face-to-face consultation, the frequency/duration of the intervention: 2 hours of consultation every 5 days) with the use of various physiotherapeutic methods: manual therapy (soft tissue therapy, joint mobilisation), exercises (patterned movement and resistance exercises) appropriate for a given group of patients, physical therapy (mainly cryotherapy, electrostimulation). The study hypothesis: An individual process of physiotherapy aimed at treating areas with structural changes results in a long-lasting improvement in the function of the locomotor system in patients with orthopedic diseases.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116050 0
Dr Alicja Jurecka
Address 116050 0
Department of Orthopedics and Physiotherapy
Faculty of Health Sciences
Jagiellonian University Medical College
Jakubowskiego 2 Str.
Krakow 30-688
Country 116050 0
Poland
Phone 116050 0
+48124002350
Fax 116050 0
Email 116050 0
[email protected]
Contact person for public queries
Name 116051 0
Alicja Jurecka
Address 116051 0
Department of Orthopedics and Physiotherapy
Faculty of Health Sciences
Jagiellonian University Medical College
Jakubowskiego 2 Str.
Krakow 30-688
Country 116051 0
Poland
Phone 116051 0
+48124002350
Fax 116051 0
Email 116051 0
[email protected]
Contact person for scientific queries
Name 116052 0
Alicja Jurecka
Address 116052 0
Department of Orthopedics and Physiotherapy
Faculty of Health Sciences
Jagiellonian University Medical College
Jakubowskiego 2 Str.
Krakow 30-688
Country 116052 0
Poland
Phone 116052 0
+48124002350
Fax 116052 0
Email 116052 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No consent from the study participants.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14349Study protocol    383248-(Uploaded-07-12-2021-09-48-56)-Study-related document.pdf
14350Ethical approval    383248-(Uploaded-07-12-2021-09-48-56)-Study-related document.pdf
15773Ethical approval    383248-(Uploaded-12-04-2022-20-38-01)-Study-related document.pdf



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.