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Trial registered on ANZCTR


Registration number
ACTRN12622001195741
Ethics application status
Approved
Date submitted
1/08/2022
Date registered
6/09/2022
Date last updated
7/07/2023
Date data sharing statement initially provided
6/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of accurate assessment methods to complement existing Clinical Pilates assessment method among adults with chronic low back pain
Scientific title
Development of objective outcome measures for Clinical Pilates assessment for chronic low back pain
Secondary ID [1] 307690 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 327238 0
Condition category
Condition code
Musculoskeletal 324377 324377 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be prescribed exercises according to Dance Medicine Australia (DMA) Clinical Pilates method (supported by Australian Physiotherapy Association). A physiotherapist will be supervising the session, one-on-one. This is a single session intervention of 30 minutes (inclusive of directional preference assessment). The mat-based exercises prescribed will be specific for each participant based on his/her movement directional preference to achieve physical performance improvements. The exercises will be of low to moderate exercise intensity, measured with RPE 10-point scale.
Examples of flexion preference exercises include cat stretch, bug legs and scissors, while examples of extension preference exercises include bridging, prone single leg kick and quadruped (leg). Lateral flexion preference exercises include mermaid and side lunges. Rotation preference exercises include bug roll (flexion) and attitude rotation (extension).
The new assessment method involves the use of portable force plate to quantify the postural sway of a person between left and right leg single-leg squat performance (5 times on each side). This could help to assist in more accurate (objective) identification of side impairment as compared to traditional observations made by a clinician/assessor that is dependent on years of clinical experience (subjective). This would also allow the understanding of the clinical pilates method of side impairment identification which at times can be different from routine interpretation, for example better performance of single-leg squat on the left than the right may not always mean that the left is not the side with impairments.
Intervention code [1] 324165 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332176 0
Centre of pressure postural sway parameters for 5 repetitions of single-leg squat, assessed using force plate.
Timepoint [1] 332176 0
Single session, assessed pre- and post-implementation of prescribed exercises.
Primary outcome [2] 332177 0
Modified-modified schober test for lumbar spine flexion flexibility (range of motion).
Timepoint [2] 332177 0
Single session, assessed pre- and post-implementation of prescribed exercises.
Primary outcome [3] 332178 0
Hamstrings muscle length test (90-90) using handheld goniometer to quantify knee flexion angle.
Timepoint [3] 332178 0
Single session, assessed pre- and post-implementation of prescribed exercises.
Secondary outcome [1] 412482 0
Pain visual numeric scale (VNS) score
Timepoint [1] 412482 0
Single session, assessed pre- and post-implementation of prescribed exercises.

Eligibility
Key inclusion criteria
- Pain in the lower back with and without lower limb symptoms on most days of the week;
- Pain in the lower back for >3 months (chronic);
- Average pain in the past week greater than or equal to 4 points rated on the 11-point pain numeric rating scale (0 = no pain); and
- Understands written and spoken English.
Minimum age
21 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Recent spinal surgery (past 6 months);
- On-going fever or infection;
- Unexplained weight loss (>5% body weight) or loss of appetite;
- Malignant cancer or received cancer intervention in the past 6 months;
- Cauda equina lesion, complete loss of bladder or bowel control, or saddle paresthesia;
- Known pregnancy at point of screening;
- Recent spinal fractures (past 3 months);
- Spinal inflammatory disease such as ankylosing spondylitis and rheumatoid arthritis; or
- Recent exercise intervention for managing low back pain (past 6 months).

Study design
Purpose of the study
Diagnosis
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
Correlation: Relationship between primary outcome measures with Clinical Pilates physical performance ratings (0 to 5).
Qualitative analyses: To explore musculoskeletal case complexity classification.
Paired sample t-test: To determine effect size of DMA Clinical Pilates intervention when intervention is individualised.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/10/2022
Actual
19/11/2022
Date of last participant enrolment
Anticipated
28/02/2023
Actual
15/06/2023
Date of last data collection
Anticipated
3/03/2023
Actual
15/06/2023
Sample size
Target
44
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 24929 0
Singapore
State/province [1] 24929 0
Singapore

Funding & Sponsors
Funding source category [1] 311960 0
Self funded/Unfunded
Name [1] 311960 0
None
Country [1] 311960 0
Primary sponsor type
University
Name
National Institute of Education
Address
1 Nanyang Walk Singapore 637616
Country
Singapore
Secondary sponsor category [1] 313446 0
None
Name [1] 313446 0
None
Address [1] 313446 0
None
Country [1] 313446 0
Other collaborator category [1] 282379 0
University
Name [1] 282379 0
Singapore Institute of Technology
Address [1] 282379 0
10 Dover Dr Singapore 138683
Country [1] 282379 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311390 0
Nanyang Technological University - Institutional Review Board
Ethics committee address [1] 311390 0
Research Integrity and Ethics Office (RIEO)
62 Nanyang Drive
Blk N1.2, B1-02A
Singapore 637459
Ethics committee country [1] 311390 0
Singapore
Date submitted for ethics approval [1] 311390 0
02/09/2022
Approval date [1] 311390 0
12/10/2022
Ethics approval number [1] 311390 0
IRB-2022-492

Summary
Brief summary
The key to the Clinical Pilates framework is to correctly identify a patient’s directional preference such that specific exercises can be prescribed. The current methods used by physiotherapist to assess directional preference rely on medical history, observation and clinical assessment. These approaches can be subjective and challenging for junior physiotherapists who have less clinical experience. To complement the current practice which requires strong clinical expertise, this study aims to develop objective methods to identify the directional preference of individual patients. In specific, we will evaluate the postural control using biomechanical instrumentation to quantify the quality of movement. It is hypothesized that the postural sway parameters during single-leg squats will correspond well with clinical ratings and assessment of directional preference.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120926 0
A/Prof Kong Pui Wah (Veni)
Address 120926 0
National Institute of Education
Nanyang Technological University
1 Nanyang Walk Singapore 637616
Country 120926 0
Singapore
Phone 120926 0
+6562196213
Fax 120926 0
Email 120926 0
[email protected]
Contact person for public queries
Name 120927 0
Kwok Boon Chong
Address 120927 0
Singapore Institute of Technology
10 Dover Dr Singapore 138683
Country 120927 0
Singapore
Phone 120927 0
+6562053794
Fax 120927 0
Email 120927 0
[email protected]
Contact person for scientific queries
Name 120928 0
Kwok Boon Chong
Address 120928 0
Singapore Institute of Technology
10 Dover Dr Singapore 138683
Country 120928 0
Singapore
Phone 120928 0
+6562053794
Fax 120928 0
Email 120928 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
Requirements of personal data protection act in Singapore


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.