ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000971932

Ethics application status

Approved

Date submitted

7/09/2011

Date registered

12/09/2011

Date last updated

12/09/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

Research study into the McKenzie method and motor control exercises on low back pain

Scientific title

A comparison of Mechanical Diagnosis & Therapy and Motor Control Exercises on the thickness of the trunk muscle in patients with chronic low back pain.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic low back pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm 1: Mechanical Diagnosis and Therapy or more commonly known as the McKenzie method - This is a system of exercises and manual therapy that uses repeated end range lumbar spine movements that promote a reduction in pain from its most distal point on the limb towards the centre of the back. The exercises are done in a specific direction (for example lumbar extension) which has been determined by a trained therapist during the patient assessment. Following the consultation the patient is asked to perform these exercises at home and implement postural correction 5 to 6 times per day for a few minutes each time. The patient is required to attend for regular reviews as clinically warranted. The patient may attend for a maximum of 12 treatments over an 8 week period. Each session may last up to 30 minutes.

Arm 2: motor control exercises - These are exercises that are specifically designed to improve the co-ordination of the trunk muscles. They are given under the guidance of a Physiotherapist who has been trained in there implementation. They are initially done in the lying position and as able are progressed to be done in sitting, standing and functional activities. Patients will receive what is clinically required as decided by the therapist. Patients may receive up to 12 sessions over an 8 week period. Each session may last up to 30 minutes. Patients will be given a home exercise program to practice at home for 30 minutes each day.

Intervention code [1]

Treatment: Other

Comparator / control treatment

motor control exercises

Control group

Active

Outcomes

Primary outcome [1]

Thickness of the trunk muscles analyzed from images obtained by real time ultrasound scans

Timepoint [1]

At time of recruitment
At time of discharge from treatment
At twelve month follow up

Secondary outcome [1]

Pain and disability will be measured by use of the following questionnaires, Patient Specific Functional Scale and the Global Perceived Effect which will be given to patients to complete while in attendance at the department.

Timepoint [1]

At time of recruitment
At time of discharge from treatment
At twelve month follow up

Secondary outcome [2]

Number of flare ups following discharge and how the patient self managed the flare up. Patients may choose to be emailed or phoned by a research assistant to ask questions regarding weather they have had a flare up of there symptoms since being discharged from active treatment. A flare up is defined as an increase in pain of more than 2 points on a 10 point scale over the last week. If they had a flare up they will be asked questions on how they managed these symptoms. and if they needed to consult a health practitioner.

Timepoint [2]

three, five, seven, nine and eleven month follow up

Eligibility

Key inclusion criteria

low back pain with or without radicular symptoms that are of more than three months duration

The patient must demonstrate centralisation or directional preference during the repeated movement testing section of the physical examination.

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Under 18 years of age
Over 70 years of age
Non-english speaking background
History of spinal surgery
History of spinal fracture
History of osteoporotic fracture
pregnancy
History of mental illness
known metastatic disease

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)

Patients must read the patient information booklet then sign the consent form.

They are then assessed by a qualified Physiotherapist which includes a complete subjective and objective examination

The findings of the lumbar movement testing section are then assessed to see if the patient demonstrates centralisation or directional preference of there symptoms. If this is identified from the examination the patient is then included

Allocation is done by a blinded person opening a sequentially numbered and sealed envelope

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Once a patient has been included, before they are allocated to a treatment arm they must under go an examination using a real time ultras sound machine to obtain images of there lower abdominal muscles. While the scan is being done the patient must perform simple lower limb exercises in a specially built frame to activate the lower abdominal muscles so they can be identified by the operator of the ultra sound scanner.

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

29/04/2011

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)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

International MDT Research Foundation

Address [1]

The International MDT Research Foundation
PO Box 0516
Lavallette, NJ 08735
USA

Country [1]

United States of America

Primary sponsor type

Charities/Societies/Foundations

Name

International MDT Research Foundation

Address

The International MDT Research Foundation
PO Box 0516
Lavallette, NJ 08735
USA

Country

United States of America

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Humen Ethics Committee (CRGH)

Ethics committee address [1]

Concord Repatriation General Hospital 
Hospital Rd. 
Concord 
NSW  2139

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The purpose of this study is to investigate the effect that the McKenzie method or lower abdominal exercises have on the thickness of the lower abdominal muscles in patients who have chronic low back pain when measured from images taken from real time ultrasound scans.  We believe that patients who receive specific lower abdominal exercises will show an increase in thickness of these muscles while those who receive the McKenzie method will not show any thickening of these muscles, while pain and disability will improve similarly in both groups.

Trial website

Trial related presentations / publications

The methodology of this trial was presented at the McKenzie Institute Australia conference in Sydney 2011

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Mark Halliday

Address

The Physiotherapy department, building 30
Concord Repatriation General Hospital
Hospital Rd.
Concord
NSW 2139

Country

Australia

Phone

+61 2 97676101

Fax

+61 2 97678448

mark.halliday@email.cs.nsw.gov.au

Contact person for scientific queries

Name

Mark Halliday

Address

The Physiotherapy department
Building 30
Concord Repatriation General Hospital
Hospital Rd.
Concord
NSW 2139

Country

Australia

Phone

+61 2 97676101

Fax

+61 2 97678448

mark.haliday@email.cs.nsw.gov.au

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	A randomized controlled trial comparing McKenzie therapy and motor control exercises on the recruitment of trunk muscles in people with chronic low back pain: A trial protocol.	2015	https://dx.doi.org/10.1016/j.physio.2014.07.001
Embase	A randomized clinical trial comparing the McKenzie method and motor control exercises in people with chronic low back pain and a directional preference: 1-year follow-up.	2019	https://dx.doi.org/10.1016/j.physio.2018.12.004

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

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Documents added manually

Documents added automatically