Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000043538
Ethics application status
Approved
Date submitted
6/09/2023
Date registered
18/01/2024
Date last updated
18/01/2024
Date data sharing statement initially provided
18/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Pilates to manage adults with chronic low back pain and examine the effects on balance, flexibility, pain and function
Scientific title
Effects of DMA Clinical Pilates on postural sway, flexibility, pain and function among adults with non-specific chronic low back pain: a randomised controlled trial
Secondary ID [1] 310554 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific chronic low back pain 331387 0
Condition category
Condition code
Musculoskeletal 328135 328135 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
DMA Clinical Pilates exercises will be prescribed according to the directional preference(s) of a participant. For example, participants who are left flexion bias (preferred direction) will start with simple left-sided trunk-hip movements into flexion, which can be progressed with exercises involving more movement phases (complex). The rate of perceived exertion of the exercises should be within 2 to 4/10 (mat work) or 4 to 6/10 (equipment-based). The intervention is conducted once weekly over 6 weeks and 30 minutes per session. The first session is face-to-face (F2F) while subsequent sessions can be virtual or F2F depending on preference of the participant.
Clinical Pilates group: Supervised by a physiotherapist with DMA Clinical Pilates certification. One-to-one session hybrid. Only sessions 2 to 5 are allowed for telerehabilitation. Home exercise adherence will be monitored weekly. The exercise protocol has been submitted to IRB for approval. The flexion exercise examples are overhead arms, bug leg, hundreds and spine stretch; Extension exercise examples are prone single leg kick, thigh stretch and scooter; Lateral flexion exercise examples are mermaid, side lunges, side clam; rotation exercise examples are bug roll, corkscrew and attitude rotation. Exercises are based on movement preference of the participants and are only done on one side at the start of the intervention.
Intervention code [1] 326952 0
Rehabilitation
Comparator / control treatment
There are 2 active controls in this study. Participants of both groups will receive intervention once weekly over 6 weeks and 30 minutes per session. The first session is face-to-face (F2F) while subsequent sessions can be virtual or F2F depending on preference of the participant.
1. The general Pilates group will receive exercises in all movement directions supervised by a physiotherapist with any Pilates certification. Rate of perceived exertion of the exercises should be within 2 to 4/10 (mat work) or 4 to 6/10 (equipment-based). One-to-one session hybrid. Only sessions 2 to 5 are allowed for telerehabilitation. Home exercise adherence will be monitored weekly. The exercise protocol has been submitted to IRB for approval. Exercises will not be tailored by movement preference and are done on both sides throughout. Examples of the exercises include overhead arms, bug leg, hundreds, spine stretch, prone single leg kick and thigh stretch.
2. The general exercise group will receive aerobic exercise (10 minutes) and hip/knee resistance/strengthening exercises (20 minutes) supervised by a physiotherapist with exercise physiologist certification. Rate of perceived exertion of the exercises should be within 4 to 6/10. One-to-one session hybrid. Only sessions 2 to 5 are allowed for telerehabilitation. Home exercise adherence will be monitored weekly. The exercise protocol has been submitted to IRB for approval. Exercises will not be tailored by movement preference and are done on both sides throughout. Example of exercises include hip extension and abduction strengthening, and calisthenics such as squats and lunges.
Control group
Active

Outcomes
Primary outcome [1] 336009 0
Postural sway centre of pressure measurements using a force plate
Timepoint [1] 336009 0
Baseline (week 0), post-intervention completion (week 6, primary timepoint) and 12 weeks post-enrolment.
Primary outcome [2] 336010 0
Hamstrings muscle length test (passive knee extension)
Timepoint [2] 336010 0
Baseline (week 0), post-intervention completion (week 6, primary timepoint) and 12 weeks post-enrolment.
Primary outcome [3] 336011 0
Modified-modified Schober test (lumbar spine flexion)
Timepoint [3] 336011 0
Baseline (week 0), post-intervention completion (week 6, primary timepoint) and 12 weeks post-enrolment.
Secondary outcome [1] 426457 0
Pain visual numeric rating for the lower back
Timepoint [1] 426457 0
Baseline (week 0), post-intervention completion (week 6) and 12 weeks post-enrolment.
Secondary outcome [2] 426458 0
Global physical function assessed using the Patient-specific functional scale
Timepoint [2] 426458 0
Baseline (week 0), post-intervention completion (week 6) and 12 weeks post-enrolment.
Secondary outcome [3] 426459 0
Disability due to lower back pain assessed using the Oswestry disability index
Timepoint [3] 426459 0
Baseline (week 0), post-intervention completion (week 6) and 12 weeks post-enrolment.
Secondary outcome [4] 426460 0
Mental wellbeing assessed using the WHO-5 Wellbeing index
Timepoint [4] 426460 0
Baseline (week 0), post-intervention completion (week 6) and 12 weeks post-enrolment.

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
50 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 3 months).

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)
Electronic database (sign-in required) accessible to investigators not involved in assessment and assigned the role to update participants and treater on the group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (blocks of 3 of 6)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 25757 0
Singapore
State/province [1] 25757 0

Funding & Sponsors
Funding source category [1] 314756 0
Self funded/Unfunded
Name [1] 314756 0
None
Country [1] 314756 0
Primary sponsor type
University
Name
Nanyang Technological University
Address
1 Nanyang Walk Singapore 637616
Country
Singapore
Secondary sponsor category [1] 316739 0
University
Name [1] 316739 0
Singapore Institute of Technology
Address [1] 316739 0
10 Dover Dr Singapore 138683
Country [1] 316739 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313764 0
Nanyang Technological University - Institutional Review Board
Ethics committee address [1] 313764 0
Research Integrity and Ethics Offi ce (RIEO)62 Nanyang DriveBlk N1.2, B1-02ASingapore 637459
Ethics committee country [1] 313764 0
Singapore
Date submitted for ethics approval [1] 313764 0
23/10/2023
Approval date [1] 313764 0
17/11/2023
Ethics approval number [1] 313764 0
2023-861

Summary
Brief summary
Pilates exercises are shown in recent studies to be effective in managing people with non-specific chronic low back pain. Several variations of Pilates exercises exist and among them is the DMA Clinical Pilates method. The DMA Clinical Pilates method tailors intervention to specific individual needs. However, literature is scarce in supporting its use, which are limited to evaluation of self-reported pain and function as outcomes. Thus, this study is initiated to investigate the effects of DMA Clinical Pilates exercises primarily on balance and flexibility. We hypothesise that the DMA Clinical Pilates exercise group will show statistically significant difference in improving postural sway, flexibility and self-reported outcomes as compared to general Pilates and general exercise groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129290 0
A/Prof Kong Pui Wah (Veni)
Address 129290 0
National Institute of Education Nanyang Technological University 1 Nanyang Walk Singapore 637616
Country 129290 0
Singapore
Phone 129290 0
+6562196213
Fax 129290 0
Email 129290 0
puiwah.kong@nie.edu.sg
Contact person for public queries
Name 129291 0
Mr Kwok Boon Chong
Address 129291 0
Singapore Institute of Technology 10 Dover Dr Singapore 138683
Country 129291 0
Singapore
Phone 129291 0
+6562053794
Fax 129291 0
Email 129291 0
boonchong.kwok@singaporetech.edu.sg
Contact person for scientific queries
Name 129292 0
Mr Kwok Boon Chong
Address 129292 0
Singapore Institute of Technology 10 Dover Dr Singapore 138683
Country 129292 0
Singapore
Phone 129292 0
+6562053794
Fax 129292 0
Email 129292 0
boonchong.kwok@singaporetech.edu.sg

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Personal Data Protection Act (PDPA) policy 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.