Trial Review

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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] 262997 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 270729 0
Condition category
Condition code
Musculoskeletal 270905 270905 0 0
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] 269344 0
Treatment: Other
Comparator / control treatment
motor control exercises
Control group
Active

Outcomes
Primary outcome [1] 279577 0
Thickness of the trunk muscles analyzed from images obtained by real time ultrasound scans
Timepoint [1] 279577 0
At time of recruitment
At time of discharge from treatment
At twelve month follow up
Secondary outcome [1] 287937 0
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] 287937 0
At time of recruitment
At time of discharge from treatment
At twelve month follow up
Secondary outcome [2] 287938 0
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] 287938 0
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?
No
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
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269809 0
Charities/Societies/Foundations
Name [1] 269809 0
International MDT Research Foundation
Country [1] 269809 0
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] 268843 0
None
Name [1] 268843 0
Address [1] 268843 0
Country [1] 268843 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271778 0
Sydney Local Health District Humen Ethics Committee (CRGH)
Ethics committee address [1] 271778 0
Concord Repatriation General Hospital
Hospital Rd.
Concord
NSW 2139
Ethics committee country [1] 271778 0
Australia
Date submitted for ethics approval [1] 271778 0
Approval date [1] 271778 0
Ethics approval number [1] 271778 0

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 33124 0
Address 33124 0
Country 33124 0
Phone 33124 0
Fax 33124 0
Email 33124 0
Contact person for public queries
Name 16371 0
Mark Halliday
Address 16371 0
The Physiotherapy department, building 30
Concord Repatriation General Hospital
Hospital Rd.
Concord
NSW 2139
Country 16371 0
Australia
Phone 16371 0
+61 2 97676101
Fax 16371 0
+61 2 97678448
Email 16371 0
[email protected]
Contact person for scientific queries
Name 7299 0
Mark Halliday
Address 7299 0
The Physiotherapy department
Building 30
Concord Repatriation General Hospital
Hospital Rd.
Concord
NSW 2139
Country 7299 0
Australia
Phone 7299 0
+61 2 97676101
Fax 7299 0
+61 2 97678448
Email 7299 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
EmbaseA 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.2015https://dx.doi.org/10.1016/j.physio.2014.07.001
EmbaseA 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.2019https://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.