Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000471482
Ethics application status
Approved
Date submitted
11/09/2007
Date registered
19/09/2007
Date last updated
1/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Short-term effects of clinical pilates on pain and function in Australian Defence Force members with chronic low back pain: A feasibility study
Scientific title
Clinical Trial: A Feasibility Study on The Short Term Effect of Clinical Pilates on Improving Function and Reducing Pain in Patients with Chronic Low Back Pain (CLBP)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain (CLBP) 2362 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2469 2469 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individual Physiotherapy prescribed Clinical Pilates intervention for patients with CLBP - 12 treatments to be conducted over six weeks
Intervention code [1] 2082 0
Rehabilitation
Intervention code [2] 2103 0
Rehabilitation
Comparator / control treatment
This study is a single-group, pretest-posttest study design to assess the effect of clinical pilates treatment intervention on pain and function outcomes in patients with chronic low back pain. Twelve treatments were administered to patients over six weeks, followed by six weeks of self-managed home exercises. Outcome assessments were measured at baseline (0 weeks), post treatment (6 weeks) and after a period of self managed home exercises (12 weeks).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3365 0
Patient Specific Functional Scale (PSFS)
Timepoint [1] 3365 0
Baseline (0 weeks), post treatment (6 weeks) and final stages of study (12 weeks).
Primary outcome [2] 257934 0
Numerical rating scale (NRS) to assess level of pain in the week prior to initial assessment.
Timepoint [2] 257934 0
Baseline (0 weeks), post treatment (6 weeks) and final stages of study (12 weeks)
Secondary outcome [1] 5583 0
Roland Morris Questionnaire
Timepoint [1] 5583 0
Pre and post intervention and six weeks post cessation of treatment
Secondary outcome [2] 263441 0
Numerical rating scale to assess pain levels on the 3 activities identified on the PSFS
Timepoint [2] 263441 0
Baseline (0 weeks), post treatment (6 weeks) and final stages of study (12 weeks)

Eligibility
Key inclusion criteria
Department of Defence personnel, male and female patients, CLBP > 12 weeks, all occupations, suitable for an exercise approach to management, symptoms from inferior angle of scapula to gluteal fold +/- leg symptoms, understanding of the trial and informed consent given
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infectious or inflammatory conditions, cauda equina compression, non-mechanical LBP, recent exercise or stabilisation programme, previous participation in a Clinical Pilates programme, pregnancy, currently undergoing physiotherapy treatment for another condition, new and/or worsening neurologic loss

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Recruitment will be from a single Navy base through self referral or via MOs, Specialists, Medics or other allied health practitioners. Patients will be given 12 treatments over six weeks and then baseline measurements will be reassessed. These measuremen
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 429 0
2011

Funding & Sponsors
Funding source category [1] 2615 0
Self funded/Unfunded
Name [1] 2615 0
Ms Anna Lewis
Country [1] 2615 0
Australia
Primary sponsor type
University
Name
The University Of Melbourne
Address
The University of Melbourne,
Faculty of Medicine, Dentistry and Health Sciences,
200 Berkeley Street,
Carlton
Country
Australia
Secondary sponsor category [1] 2365 0
Other
Name [1] 2365 0
HMAS Kuttabul - Physiotherapy Department
Address [1] 2365 0
FBEMC; Building 921,
Wylde Street,
Potts Point NSW 2011
Country [1] 2365 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4534 0
Australian Defence Human Research Ethics Committee
Ethics committee address [1] 4534 0
CP2-7-124.
Department of Defence,
Canberra ACT 2600
Ethics committee country [1] 4534 0
Australia
Date submitted for ethics approval [1] 4534 0
01/01/2008
Approval date [1] 4534 0
Ethics approval number [1] 4534 0
Ethics committee name [2] 4535 0
Ethics committee address [2] 4535 0
Ethics committee country [2] 4535 0
Date submitted for ethics approval [2] 4535 0
01/01/2008
Approval date [2] 4535 0
Ethics approval number [2] 4535 0

Summary
Brief summary
This trial is a before and after study design on one group of patients to assess the effects of Clinical Pilates intervention. Patients presenting to the Physiotherapy Department either through self-referral or referral from a MO or Specialist will be assessed for suitability for inclusion in the trial and will be given the appropriate information and informed consent will then be sought.
The primary aim of this study is to assess the effectiveness of Clinical Pilates on pain and function in patients with Chronic Low Back Pain. The hypothesis is that there will be clinically and statistically significant positive outcomes based on current clinical practice in the physiotherapy department at HMAS Kuttabul.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28048 0
Address 28048 0
Country 28048 0
Phone 28048 0
Fax 28048 0
Email 28048 0
Contact person for public queries
Name 11205 0
Ms Anna Lewis - Senior Physiotherapist
Address 11205 0
HMAS Kuttabul - FBEMC,
Physiotherapy Department, Bld 921,
Wylde Street, Potts Point 2011
Country 11205 0
Australia
Phone 11205 0
02 9359 3375
Fax 11205 0
02 9359 2503
Email 11205 0
[email protected]
Contact person for scientific queries
Name 2133 0
Ms Anna Lewis - Senior Physiotherapist
Address 2133 0
HMAS Kuttabul - FBEMC,
Physiotherapy Department, Bld 921,
Wylde Street, Potts Point 2011
Country 2133 0
Australia
Phone 2133 0
02 9359 3375
Fax 2133 0
02 9359 2503
Email 2133 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
EmbasePilates for low back pain.2015https://dx.doi.org/10.1002/14651858.CD010265.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.