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Trial registered on ANZCTR


Registration number
ACTRN12618001226291
Ethics application status
Approved
Date submitted
17/07/2018
Date registered
20/07/2018
Date last updated
22/10/2021
Date data sharing statement initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Low-intensity Pulsed Ultrasound as an adjunct to usual Physiotherapy on Recovery of Physical Impairments, Functional Performance and Quality of Life in Patients with Total Knee Arthroplasty
Scientific title
Effects of Low-intensity Pulsed Ultrasound as an adjunct to usual Physiotherapy on Recovery of Physical Impairments, Functional Performance and Quality of Life in Patients with Total Knee Arthroplasty
Secondary ID [1] 295588 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12618001208291

This record (ACTRN12618001208291) is a pilot study of this study. The pilot study is conducted to test procedures and process of the study and to obtain approximates of parameters for sample size calculation of this study.

Health condition
Health condition(s) or problem(s) studied:
Postoperative total knee arthroplasty 308887 0
Condition category
Condition code
Musculoskeletal 307798 307798 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will undergo TKA surgery and during the surgical procedure, the designated surgeon will measure the thickness of tissues using patella caliper. After that, each patient will receive the following interventions:
• Pulsed ultrasound with low-intensity
- Duty cycle: 20% (1:4)
- Frequency: 1 or 3 MHz (will be based on the thickness of patient’s tissues)
- Intensity: 0.1 – 0.3 W/cm2 (will be based on the thickness of patient’s tissues)
- Treatment time: 3-5 minutes (will be based on the size of the area treated)
- An area to be treated: 0.5 cm away from the medial side of the patella
- Duration of the treatment: 3 weeks (4-5 times/week for the first-week post-TKA, at an orthopedic ward and 2-3 times/week for a further 2 weeks, at physiotherapy department)
- Transducer head and any other equipment related to the pulsed ultrasound treatment will be cleaned with the alcohol-based swab before and after the treatment
- A researcher (physiotherapist) will deliver the intervention

• TKA physiotherapy rehabilitation (4-5 times/week for the first-week post-TKA, at an orthopedic ward and 2-3 times/week for a further 11 weeks, at physiotherapy department). The rehabilitation guideline for TKA that will be used in this study is based on the general physiotherapy rehabilitation program for TKA in Universiti Kebangsaan Malaysia Medical Centre. A physiotherapist for in-patient and a physiotherapist for out-patient will administer the rehabilitation. The rehabilitation guideline is as below:

Pre-operative
• Chest physio
• Exercise education: Quad sets, Gluteus Set, Ankle pump
Inpatient
• PRICE
• Chest physio
• Circulation exercises
• Range of motion (ROM) exercises
• Strengthening exercises
• Mobility training
• Gait re-education
• Gentle patella mobilization as appropriate
• Patient education
Outpatient
• Continue ice therapy as needed
• ROM exercises
• Strengthening exercises
• Stretching exercises
• Balance, proprioception and agility exercises
• Gait re-education/functional training
• Gentle patella mobilization as appropriate
• Soft tissue mobilization as appropriate
• Advice/Patient education

• All participants will be instructed to do home exercise programme 2 times per day. The home exercise programme includes ankle pump exercise, strengthening exercises, and stretching exercises.

• A telephone call will be made once a week to friendly remind them to do the home exercises programme and to monitor their progression and potential adverse effects related to exercise such as cramps and muscle soreness.

• All participants will also be provided with exercises diary to record their home exercises programme that has been done.

• Any amendments to the procedure and process of the pilot study will be applied to this study.
Intervention code [1] 301886 0
Treatment: Other
Comparator / control treatment
Patients will undergo TKA surgery. After that, each patient will receive the physiotherapy treatment:
• TKA physiotherapy rehabilitation (4-5 times/week for the first-week post-TKA, at an orthopedic ward and 2-3 times/week for a further 11 weeks, at physiotherapy department). The rehabilitation guideline for TKA that will be used in this study is based on the general physiotherapy rehabilitation program for TKA in Universiti Kebangsaan Malaysia Medical Centre. A physiotherapist for in-patient and a physiotherapist for out-patient will administer the rehabilitation. The rehabilitation guideline is as below:

Pre-operative
• Chest physio
• Exercise education: Quad sets, Gluteus Set, Ankle pump
Inpatient
• PRICE
• Chest physio
• Circulation exercises
• Range of motion (ROM) exercises
• Strengthening exercises
• Mobility training
• Gait re-education
• Gentle patella mobilization as appropriate
• Patient education
Outpatient
• Continue ice therapy as needed
• ROM exercises
• Strengthening exercises
• Stretching exercises
• Balance, proprioception and agility exercises
• Gait re-education/functional training
• Gentle patella mobilization as appropriate
• Soft tissue mobilization as appropriate
• Advice/Patient education

• All participants will be instructed to do home exercise programme 2 times per day. The home exercise programme includes ankle pump exercise, strengthening exercises, and stretching exercises.

• A telephone call will be made once a week to friendly remind them to do the home exercises programme and to monitor their progression and potential adverse effects related to exercise such as cramps and muscle soreness.

• All participants will also be provided with exercises diary to record their home exercises programme that has been done.

• Any amendments to the procedure and process of the pilot study will be applied to this study.
Control group
Active

Outcomes
Primary outcome [1] 306784 0
Knee pain after TKA surgery assessed using a 10 cm Visual Analogue Scale (VAS)
Timepoint [1] 306784 0
- Baseline (post-operative day 2)
- 1-week after TKA surgery
- 4-week after TKA surgery (primary endpoint)
Primary outcome [2] 306785 0
Knee swelling assessed using a measuring tape
Timepoint [2] 306785 0
- Baseline (post-operative day 2)
- 1-week after TKA surgery
- 4-week after TKA surgery (primary endpoint)
Primary outcome [3] 306786 0
Active knee range of motion assessed using a standard long-arm goniometer
Timepoint [3] 306786 0
- Baseline (post-operative day 2)
- 1-week after TKA surgery
- 4-week after TKA surgery (primary endpoint)
Secondary outcome [1] 349647 0
Primary outcome: Quadriceps strength assessed using a hand-held dynamometer
Timepoint [1] 349647 0
- Baseline (post-operative day 2)
- 1-week after TKA surgery
- 4-week after TKA surgery (primary endpoint)
Secondary outcome [2] 349651 0
Quality of life assessed using 5-level EQ-5D
Timepoint [2] 349651 0
- Baseline (Post-operative day 2)
- 12-week after TKA surgery
- 6-month after TKA surgery
Secondary outcome [3] 402186 0
Lower Extremity Functional Scale
Timepoint [3] 402186 0
- Baseline (Post-operative day 2)
- 12-week after TKA surgery
- 6-month after TKA surgery

Eligibility
Key inclusion criteria
Aged 50 to 80 years
• Patients who underwent TKA surgery on one knee due to knee osteoarthritis
• The TKA with using posterior stabilized cemented total knee replacement
• Patients who reported able to walk and climb up and down stair
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Contraindication to pulsed ultrasound (e.g. malignancy at the tissue to be treated, bleeding at the area of surgery and deep vein thrombosis)
• Has coexisting or history of diseases, which might limit the physical function and functional performance such as old fractures in the lower limb, neurology diseases (e.g. stroke) and other musculoskeletal problem.
• Has TKA complication(s) such as myocardial infarction, deep vein thrombosis, septic arthritis and neurological deficit due to regional anaesthesia complications.

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
ANOVA repeated measures, within-between interaction statistical test will be used to calculate the sample size required for this study. This calculation will be set with the number of groups and measurements are 2 and 5, respectively. The effect size will be determined by using partial eta squared value from the result of the pilot study with an alpha level of 0.05 alpha and a statistical power of 80%.

Statistical method:
1) Mixed model ANOVA
- To evaluate whether the changes in patients’ pain, knee swelling, knee range of motion and quadriceps strength from baseline measures over the duration of study is different for the two groups
- To evaluate whether the recovery of the patients’ functional performance and quality of life from baseline measures over the duration of study is different for the two groups.

2) Multiple regression
- To determine how much do recovery in physical impairments following low-intensity pulsed ultrasound as an adjunct to usual physiotherapy influence the functional performance and quality of life of patients with TKA.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
A total of 32 participants was the sample size required in this study, where the sample size calculation was based on the results of the pilot study.
Date of first participant enrolment
Anticipated
20/09/2019
Actual
20/09/2019
Date of last participant enrolment
Anticipated
Actual
13/12/2019
Date of last data collection
Anticipated
Actual
29/05/2020
Sample size
Target
60
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 10665 0
Malaysia
State/province [1] 10665 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 300165 0
University
Name [1] 300165 0
Universiti Kebangsaan Malaysia
Country [1] 300165 0
Malaysia
Primary sponsor type
Individual
Name
Munayati Munajar@Munajat
Address
Post-graduate student
Program of Physiotherapy
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300
Country
Malaysia
Secondary sponsor category [1] 299573 0
None
Name [1] 299573 0
Address [1] 299573 0
Country [1] 299573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300998 0
Research Ethics Committee of the Universiti Kebangsaan Malaysia Medical Centre
Ethics committee address [1] 300998 0
Ethics committee country [1] 300998 0
Malaysia
Date submitted for ethics approval [1] 300998 0
19/03/2018
Approval date [1] 300998 0
03/05/2018
Ethics approval number [1] 300998 0
NN-2018-111

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85550 0
A/Prof Nor Azlin Mohd Nordin
Address 85550 0
Head,
Program of Physiotherapy
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 85550 0
Malaysia
Phone 85550 0
+60193594418
Fax 85550 0
Email 85550 0
norazlin8@ukm.edu.my
Contact person for public queries
Name 85551 0
Munayati Munajar@Munajat
Address 85551 0
Post-graduate student
Program of Physiotherapy
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300
Kuala Lumpur
Country 85551 0
Malaysia
Phone 85551 0
+60127596419
Fax 85551 0
Email 85551 0
p90370@siswa.ukm.edu.my
Contact person for scientific queries
Name 85552 0
Nor Azlin Mohd Nordin
Address 85552 0
Head,
Program of Physiotherapy
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 85552 0
Malaysia
Phone 85552 0
+60193594418
Fax 85552 0
Email 85552 0
norazlin8@ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All the data will be kept confidential as the access to the data is only by the research team and the REC UKM. The data will be reported in a collective manner with no reference to an individual.


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.