Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000565246
Ethics application status
Approved
Date submitted
14/03/2009
Date registered
10/07/2009
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a Physiotherapy Exercise Program to Change Spinal Movement and
Reduce Low Back Pain in Schoolboy Rowers
Scientific title
Effects of a Physiotherapy Exercise Program to Change Spinal Movement and
Reduce Low Back Pain in Schoolboy Rowers
Secondary ID [1] 288159 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 4477 0
Condition category
Condition code
Musculoskeletal 4750 4750 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 237511 237511 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An individual exercise program will be formed and implemented based on the impairments identified in the interview and physical examination. The intervention program will address the individuals’ impairments and aim to train control of the lumbar lordosis during sitting, squatting and rowing, with progressions to improve the strength and endurance of the lower limb and back muscles during these tasks with increased load and endurance demands. Subsequent to the initial examination each subject in the intervention group will receive 4 physiotherapy sessions, with a review at 1, 3, 5 and 7 weeks following the initial session to monitor adherence and understanding of the exercise program and to progress the exercises. The subjects will be asked to complete these exercises over a 12 week period.

All exercise programs prescribed to the rowers will be written on a sheet of paper with diagrammatic representation and a brief explanation of the exercises. The rowers will be told to perform the prescribed exercises daily throughout the course of the rowing season. Rowers will also be asked to fill in a compliance sheet to indicate the level of adherence to the program. All assessments and interventions will be carried out in a private physiotherapy practice in Perth, and will be provided by a physiotherapist with post-graduate qualification and experience in a previous intervention research in adolescent female rowers.
Intervention code [1] 4220 0
Rehabilitation
Comparator / control treatment
The control group will not receive physiotherapy exercise intervention, but will continue through the rowing season as usual and undergo the same coaching and conditioning program as the intervention group. The subjects in this group will be asked not to participate in exercise or physiotherapy treatment therapy over a 12 week period.
Control group
Active

Outcomes
Primary outcome [1] 5616 0
Self reported Low Back Pain (LBP) on the Visual Analogue Scale (VAS). This scale will collect pain information on rowers during functional activities on the week prior to data collection.
Timepoint [1] 5616 0
The self reported pain will be recorded during the initial data collection period (Time 0). Following this initial assessment, rowers in the intervention group will receive treatment and the control group will continue their normal rowing training. Eight weeks following initial treatment, the self reported pain will be collected again (Week 8 follow up) and then again 12 weeks after initial assessment.
Secondary outcome [1] 9454 0
Whilst the rowers are rowing on the ergometer, spinal kinematics data will be collected using the 3-Space Fastrak system (an electromagnetic device to measure spinal angles). Using this device, the sacral angle, lower lumbar curvature, upper lumbar curvature and thoracic angles will be derived.
Timepoint [1] 9454 0
The spinal kinematics will be recorded during the initial data collection period (Time 0). The VAS will be collected during every minute of the rowing ergometer trial. The rowers in the intervention group will receive treatment and the control group will continue their normal rowing training. Eight weeks following initial treatment, the ergometer trial will be repeated, spinal kinematics will be collected (Week 8 follow up).
Secondary outcome [2] 9455 0
The Roland Morris Low Back Pain and Disability Questionnaire will be completed prior to rowing ergometry testing.
Timepoint [2] 9455 0
The Roland Morris Disability Scale will be collected prior to rowing ergometer trial at the initial data collection (week 0), this test will be repeated at 8 weeks and 12 weeks following the initial trial.
Secondary outcome [3] 9456 0
The Patient Specific Functional Scale on the level of pain during functional activities.
Timepoint [3] 9456 0
The Patient Specific Functional Scale will be collected prior to rowing ergometer trial at the initial data collection (week 0), this test will be repeated at 8 weeks and 12 weeks following the initial trial.
Secondary outcome [4] 9457 0
Numeric Pain Rating Scale
Timepoint [4] 9457 0
The Numeric Pain Rating Scale (NPFS) will be collected during initial ergometer rowing trials. The NPFS will be collected every minute of the 20 minute rowing ergometry trial. The test will be completed in the initial data collection, and then again 8 weeks following initial data collection session.

Eligibility
Key inclusion criteria
Minimum age
14 Years
Maximum age
19 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of specific causes of Low Back Pain (LBP) such as inflammatory diseases or abnormal cell growth (such as cancer), unexplained weight loss and/or neurological signs

Past medical history including specific diagnoses for LBP disorder such as disc prolapse with radicular pain, severe scoliosis, spondylolisthesis, previous spinal surgery, musculoskeletal injury of the extremities in the previous six weeks

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)
40 adolescent male rowers with LBP between 14 to 17 years of age will be recruited for the study from local rowing clubs. Participation is voluntary. Informed consent will be collected from the rowers and their parent/guardian. The subjects that meet the inclusion criteria will be assigned an identification number. They will then be randomly allocated to an intervention or a control group using the random number generator in Microsoft Excel 2003 that will generate a number between 0 and 1. The twenty lowest numbers will be assigned to the control group. This will be completed by an independent investigator who is not involved with data collection, intervention prescription or data analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using the random number generator in Microsoft Excel 2003 that will generate a number between 0 and 1. The twenty lowest numbers will be assigned to the control group. The allocation will only be known to an independent investigator who will not be involved with participant recruitment, intervention or follow-up assessment. Participants in both groups will receive an identification number. To prevent investigator/assessor bias, allocation concealment will be achieved by participants in both groups receiving a sealed, opaque envelope containing their identification number, information sheet and consent forms to participate in this research.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2009
Actual
10/01/2010
Date of last participant enrolment
Anticipated
Actual
4/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4667 0
Self funded/Unfunded
Name [1] 4667 0
Country [1] 4667 0
Funding source category [2] 292566 0
Other Collaborative groups
Name [2] 292566 0
Physiotherapy Research Foundation
Country [2] 292566 0
Australia
Primary sponsor type
Individual
Name
Leo Ng
Address
Curtin University of Technology
GPO Box U1987
Perth, Western Australia, 6845
Country
Australia
Secondary sponsor category [1] 4213 0
None
Name [1] 4213 0
Address [1] 4213 0
Country [1] 4213 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239390 0
Curtin University of Technology Ethics Committee
Ethics committee address [1] 239390 0
Ethics committee country [1] 239390 0
Australia
Date submitted for ethics approval [1] 239390 0
04/12/2008
Approval date [1] 239390 0
31/03/2009
Ethics approval number [1] 239390 0
HR 197/2008

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

Contacts
Principal investigator
Name 29398 0
Dr Leo Ng
Address 29398 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country 29398 0
Australia
Phone 29398 0
+61 8 9266 1001
Fax 29398 0
Email 29398 0
[email protected]
Contact person for public queries
Name 12645 0
Leo Ng
Address 12645 0
School of Physiotherapy and Exercise Science
Curtin University
Kent St, Bentley, WA
6102
Country 12645 0
Australia
Phone 12645 0
+61 8 9266 4644
Fax 12645 0
+61 8 9266 3699
Email 12645 0
[email protected]
Contact person for scientific queries
Name 3573 0
Leo Ng
Address 3573 0
School of Physiotherapy and Exercise Science
Curtin University
Kent St, Bentley, WA
6102
Country 3573 0
Australia
Phone 3573 0
+ 61 8 9266 4644
Fax 3573 0
+ 61 8 9266 3699
Email 3573 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseCognitive functional approach to manage low back pain in male adolescent rowers: a randomised controlled trial.2015https://dx.doi.org/10.1136/bjsports-2014-093984
N.B. These documents automatically identified may not have been verified by the study sponsor.