ANZCTR - Registration

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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)

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

Rehabilitation

Intervention code [2]

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]

Patient Specific Functional Scale (PSFS)

Timepoint [1]

Baseline (0 weeks), post treatment (6 weeks) and final stages of study (12 weeks).

Primary outcome [2]

Numerical rating scale (NRS) to assess level of pain in the week prior to initial assessment.

Timepoint [2]

Baseline (0 weeks), post treatment (6 weeks) and final stages of study (12 weeks)

Secondary outcome [1]

Roland Morris Questionnaire

Timepoint [1]

Pre and post intervention and six weeks post cessation of treatment

Secondary outcome [2]

Numerical rating scale to assess pain levels on the 3 activities identified on the PSFS

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

2011

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Ms Anna Lewis

Address [1]

Physiotherapy Department, HMAS Kuttabul,
FBEMC, Bld 921,
Wylde Street, Potts Point 2011

Country [1]

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]

Other

Name [1]

HMAS Kuttabul - Physiotherapy Department

Address [1]

FBEMC; Building 921,
Wylde Street,
Potts Point NSW 2011

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Defence Human Research Ethics Committee

Ethics committee address [1]

CP2-7-124.
Department of Defence, 
Canberra ACT 2600

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/01/2008

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Ethics committee address [2]

Ethics committee country [2]

Date submitted for ethics approval [2]

01/01/2008

Approval date [2]

Ethics approval number [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Ms Anna Lewis - Senior Physiotherapist

Address

HMAS Kuttabul - FBEMC,
Physiotherapy Department, Bld 921,
Wylde Street, Potts Point 2011

Country

Australia

Phone

02 9359 3375

Fax

02 9359 2503

[email protected]

Contact person for scientific queries

Name

Ms Anna Lewis - Senior Physiotherapist

Address

HMAS Kuttabul - FBEMC,
Physiotherapy Department, Bld 921,
Wylde Street, Potts Point 2011

Country

Australia

Phone

02 9359 3375

Fax

02 9359 2503

[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

Source	Title	Year of Publication	DOI
Embase	Pilates for low back pain.	2015	https://dx.doi.org/10.1002/14651858.CD010265.pub2

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically