Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000735459
Ethics application status
Approved
Date submitted
29/05/2016
Date registered
3/06/2016
Date last updated
7/12/2018
Date data sharing statement initially provided
7/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two exercise approaches for the management of low Back pain in the emergency department setting.
Scientific title
Comparison of two exercise approaches for the management of low Back pain in the emergency department setting.
Secondary ID [1] 289330 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 298936 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299013 299013 0 0
Physiotherapy
Musculoskeletal 299053 299053 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
McKenzie approach for treatment of acute low back pain.
The McKenzie method of mechanical diagnosis & therapy is an active exercise approach involving repeated movements, sustained positions and therapeutic forces, it has an educational component with the purpose of minimising pain, disability, and improving spinal mobility. This method involves the assessment of symptomatic and mechanical responses to repeated movements and sustained positions. The responses are used to classify them into subgroups or syndromes (Posture, Dysfunction and Derangement) which help in guiding the treatment principles.
Physiotherapist (assessor) will perform a physical assessment of lumbar range of motion & palpation, he/she will also look for any directional bias the symptoms have.
Depending on whether the patient responds to flexion or extension movement, exercises will be prescribed to the patient on the day of presentation in the emergency department.
This process of assessment and treatment takes around 90minutes.
The patient will also receive analgesia(NSAIDS, paracetamol & opioids if necessary.
The patient will asked to perform the same set of exercises 20minutes 4/day for 2weeks at home.(exercise sheets will be provided for assistance)
The patient will be provided with an daily exercise checklist which he would return by a reply paid envelope to the principle investigator. Patient education provided will help improve exercise adherence.
Intervention code [1] 294887 0
Treatment: Other
Intervention code [2] 294930 0
Rehabilitation
Comparator / control treatment
Management will include patient education and assurance , symptom relief by analgesia (NSAIDS, paracetamol & opioids if necessary), as well as recommendation to stay as active as possible including return to work .
The assessor (Physiotherapist) will perform a subjective & objective (assessment of range of motion & palpation) assessment to rule out serious pathology.
The patient will be shown gentle range of motion(mobility) and core activation(stability) exercises 10 reps, which he will also be asked to continue 10minutes 3-4/day for 2 weeks at home, exercise sheets will be provided. The patient will be provided with an daily exercise checklist which he would return by a reply paid envelope to the principle investigator. Patient education provided will help improve exercise adherence.
The assessment and treatment will take around 60minutes.
Control group
Active

Outcomes
Primary outcome [1] 298475 0
Pain score (0-10)
Timepoint [1] 298475 0
The baseline pain score will be recorded on the day of presentation to the emergency dept & again on a 2 week telephonic follow-up post discharge.
Secondary outcome [1] 324276 0
Roland Morris disability questionnaire.
The questionnaire has 24 questions which show inability to do daily tasks due to back pain, reduction in score shows improvement, a change of > 2 is clinically significant.
Timepoint [1] 324276 0
The baseline score will be recorded on the day of presentation to the emergency dept & again on a 2 week telephonic follow-up post discharge.

Eligibility
Key inclusion criteria
Inclusion criteria
Low back pain (LBP) – atraumatic onset.
Age – 20-50 years
Gender – Male and/or Female.
Low back pain of Musculoskeletal origin (which will be confirmed by a subjective & objective assessment, imaging will be performed if indicated)
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of substance abuse eg: IV drug user (IVDU), ETOH
Spinal fractures.
Pregnant women
Neurological compromise (as shown by loss of strength, sensations
and reflexes).
Red flags eg: loss of weight, fever, history of cancer.
Multiple medical co-morbidities (chronic obstructive pulmonary disease, ischemic heart disease, chronic kidney disease, uncontrolled diabetes and hypertension).
Patients brought in by police who are under influence of illicit drugs and alcohol.
Patients bought in by police who will remain in custody.
Patients with known cognitive and intellectual disability (decided on the basis of information collected by the triage nurse).
Patients having an acute concurrent systemic illness.
Patients with congenital spinal structural deformity.
Patients unable to provide consent and comply with the home exercise program.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2016
Actual
22/08/2016
Date of last participant enrolment
Anticipated
1/07/2019
Actual
Date of last data collection
Anticipated
15/07/2019
Actual
Sample size
Target
50
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5865 0
Royal Brisbane & Womens Hospital - Herston

Funding & Sponsors
Funding source category [1] 293707 0
Self funded/Unfunded
Name [1] 293707 0
Mahender Samtani
Country [1] 293707 0
Australia
Primary sponsor type
Individual
Name
Mahender Samtani
Address
Physiotherapy dept,
Level II Ned Hanlon bldg
Royal Brisbane & Women's hospital
Cnr of Butterfield street & Bowen bridge road
Herston, Brisbane, Qld 4029.
Country
Australia
Secondary sponsor category [1] 292541 0
None
Name [1] 292541 0
NA
Address [1] 292541 0
NA
Country [1] 292541 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295143 0
Human research ethics committee, Royal Brisbane & Women's hospital.
Ethics committee address [1] 295143 0
Ethics committee country [1] 295143 0
Australia
Date submitted for ethics approval [1] 295143 0
23/01/2016
Approval date [1] 295143 0
24/05/2016
Ethics approval number [1] 295143 0
EC00172

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

Contacts
Principal investigator
Name 66274 0
Mr Mahender Samtani
Address 66274 0
Physiotherapy department,
Royal Brisbane & Women's hospital
Cnr Butterfield street & Bowen bridge road.
Level II, Ned Hanlon Bldg.
Herston, Qld, 4029.
Country 66274 0
Australia
Phone 66274 0
+61736474610
Fax 66274 0
Email 66274 0
[email protected]
Contact person for public queries
Name 66275 0
Mahender Samtani
Address 66275 0
Physiotherapy department,
Royal Brisbane & Women's hospital
Cnr Butterfield street & Bowen bridge road.
Level II, Ned Hanlon Bldg.
Herston, Qld, 4029.
Country 66275 0
Australia
Phone 66275 0
+61736474610
Fax 66275 0
Email 66275 0
[email protected]
Contact person for scientific queries
Name 66276 0
Mahender Samtani
Address 66276 0
Physiotherapy department,
Royal Brisbane & Women's hospital
Cnr Butterfield street & Bowen bridge road.
Level II, Ned Hanlon Bldg.
Herston, Qld, 4029.
Country 66276 0
Australia
Phone 66276 0
+61736474610
Fax 66276 0
Email 66276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
participants will not be identifiable as per protocol.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
577Study protocol    370804-(Uploaded-30-11-2018-14-54-56)-Study-related document.pdf
578Ethical approval    370804-(Uploaded-30-11-2018-14-55-15)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.