Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001360404
Ethics application status
Approved
Date submitted
27/09/2016
Date registered
30/09/2016
Date last updated
30/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lumbar microdiscectomy and post-operative activity restrictions
Scientific title
Impact of post-operative activity restrictions on lumbar microdiscectomy clinical outcome: a single blinded randomized controlled trial
Secondary ID [1] 290222 0
None
Universal Trial Number (UTN)
U1111-1188-0439
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar Intervertebral Disc Degeneration 300404 0
Condition category
Condition code
Musculoskeletal 300265 300265 0 0
Other muscular and skeletal disorders
Surgery 300266 300266 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial investigates post-operative activity restrictions following lumbar discectomy. Patients are randomized prior to lumbar microdiscectomy surgery at L3/4, L4/5 or L5/S1 intervertebral discs to receive either the intervention (no post-operative activity restrictions for a period of one month following the procedure) or control group (traditional post-operative activity restrictions- defined below). The lumbar microdiscectomy operation is performed by Consultant Neurosurgeons or under the supervision of Consultant Neurosurgeons in participating hospitals in Melbourne.

Intervention group patients are advised by neurosurgical ward physiotherapists post-operatively to return to all activities as soon as they feel ready with no restrictions placed on sitting, exercise, return to work or sexual activity. The same information is communicated in an information sheet provided to patients. Patients wear a portable electronic device for a period of one month following their procedure which records activity and position: lying, sitting, standing, walking, running or cycling.
Intervention code [1] 295995 0
Treatment: Other
Comparator / control treatment
The control group also receives the following advice from the ward physiotherapist in a 10-minute face-to-face discussion with an accompanying information sheet to restrict activity for a period of one month following lumbar microdiscetomy:
1. Avoid sitting for longer than 15-30 minutes in any 2 hour period
2. No bending, lifting, twisting, pulling or pushing greater than 5 kilograms
3. Avoid heavy domestic work such as vacuuming, laundry and making beds for the first fortnight
4. Do not drive until reviewed in the outpatient clinic at one month
5. Avoid sexual activity for two weeks
The control group also wears the portable monitoring device
Control group
Active

Outcomes
Primary outcome [1] 299742 0
A well-defined and widely agreed definition of clinical success following lumbar microdiscectomy does not exist. It is, however, accepted that such a definition of success should take account of outcome measures such as physical function, disability and pain. The primary endpoint will be a composite outcome at six months consisting of:

1. 18 point reduction in Visual Analogue Scale (VAS) for lower back pain
2. 25 point reduction in VAS for leg pain
3. 15 point improvement in ODI score
4. Absence of disc reherniation (defined as repeat surgery at the same level)
5. No other secondary intervention (epidural or nerve root injection, medial branch block)
Timepoint [1] 299742 0
Six months
Secondary outcome [1] 327977 0
Mean Visual Analogue Scale for leg pain- absolute and change scores
Timepoint [1] 327977 0
Pre-operatively, Day 1 post-operatively, 1 month, 3months and 6 months
Secondary outcome [2] 327978 0
Mean Visual Analogue Scale for lower back pain- absolute and change scores
Timepoint [2] 327978 0
Pre-operatively, Day 1 post-operatively, 1 month, 3months and 6 months
Secondary outcome [3] 327979 0
Oswestry Disability Index- absolute and change scores
Timepoint [3] 327979 0
Pre-operatively, Day 1 post-operatively, 1 month, 3months and 6 months
Secondary outcome [4] 327980 0
Disc Reherniation Rates- investigated upon clinical suspicion of recurrence with repeat MRI lumbar spine. Confirmed with repeat MRI Lumbar Spine.
Timepoint [4] 327980 0
6 months.
Disc Reherniation rates will be determined by clinical review and MRI if indicated at 6 months. The monitoring device is only worn for a period of one month during which patients are asked to follow specific activity restrictions. The 6 month time point is used to determine the longer term risk of disk reherniation after the period of activity restrictions.
Secondary outcome [5] 327981 0
An additional secondary outcome will consist of a composite of the below assessed on as treated basis (in contradistinction to the primary outcome assessed on an as-treated basis):

1. 18 point reduction in Visual Analogue Scale (VAS) for lower back pain
2. 25 point reduction in VAS for leg pain
3. 15 point improvement in ODI score
4. Absence of disc reherniation (defined as repeat surgery at the same level)
5. No other secondary intervention (epidural or nerve root injection, medial branch block)
Timepoint [5] 327981 0
6 months.
The composite endpoint will be assessed on an as treated basis at 6 months. The monitoring device is only worn for a period of one month during which patients are asked to follow specific activity restrictions. The 6 month time point is used to determine the longer term outcome after the period of activity restrictions.

Eligibility
Key inclusion criteria
1. Suffering from radiculopathy or radicular pain with concordant MRI evidence of lumbar disc herniation at L3/4, L4/5 or L5/S1
2. Deemed appropriate and booked for lumbar microdiscectomy by the treating clinician
3. Who agree to routine follow-up examination at 1 month, 3 months and 6 months
4. Who agree to wear a small electronic device to monitor position over a period of one month
5. Age 18 to 75
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous history of lumbar surgery, spinal infection or fracture.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering 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
Safety/efficacy
Statistical methods / analysis
Statistical methods

Power Calculation
To our knowledge, there is no previous RCT assessing our hypothesis. Previous studies have indicated a reherniation rate of ranging from 2-18%. Annual reported reherniation rates have been closer to 4-5% in large series. Reported rates of clinical success for lumbar discectomy vary widely dependent on the criteria. Using the criteria detailed above we would anticipate a clinical success rate within the broad range reported in the literature of approximately 70-90%.

In determining the power of this study, we assume that 80% of patients will meet the definition of treatment success. The calculation of sample size can be based upon a threshold of a 25% difference in treatment success as clinically significant. In order to have 80% power to detect a 25% difference in the binomial outcome of treatment success defined at p=0.05 the sample size calculated would be 50 patients per group. If we allow for a 20% drop-out rate, this bring the calculated sample size to 60 patients per group for a total of 120 patients in the trial.




Multivariate Analysis
Baseline multivariate analysis will be performed on enrolled patients once randomized to detect any underlying important difference in demographics. The baseline characteristics to be assessed include:
Demographic/Baseline Characteristics
Age
Sex
Employment status- employed/unemployed
Work type (physical requirement)
Light
Medium
Heavy
Worker’s Compensation Status
Duration of symptoms


Operation information will also be recorded:
Operative level
Length of operation
Inadvertent durotomy
Length of admission


Populations for Analysis
Populations will be analyzed on an intention to treat basis.

Primary Endpoints
The proportion of patients from each group achieving the primary endpoint at six months as defined above will be assessed on an intention to treat basis via the Two One-Sided T-Test.

Secondary Endpoints
The secondary endpoints of VAS scores back and legs (absolute and change) and ODI (absolute and change) will also be assessed on an intention to treat basis. Adherence to protocol will be assessed via interpretation of the data recorded by the electronic device over the one month post-operative period. Disc reherniation rates will also be assessed on an intention to treat basis. The composite endpoint will also be assessed on an as treated basis as determined by wearable device reported adherence.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/02/2016
Date of last participant enrolment
Anticipated
18/12/2017
Actual
Date of last data collection
Anticipated
1/07/2018
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6742 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 6743 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [3] 6744 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 14387 0
3168 - Clayton
Recruitment postcode(s) [2] 14388 0
3144 - Malvern
Recruitment postcode(s) [3] 14389 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 294583 0
Charities/Societies/Foundations
Name [1] 294583 0
Cabrini Foundation
Country [1] 294583 0
Australia
Funding source category [2] 294584 0
University
Name [2] 294584 0
Monash University Department of Surgery
Country [2] 294584 0
Australia
Primary sponsor type
Individual
Name
Assoc. Prof. Tony Goldschlager
Address
Department of Neurosurgery
Monash Medical Centre
246 Clayton Rd,
Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 293453 0
Individual
Name [1] 293453 0
Dr Chris Daly
Address [1] 293453 0
Department of Neurosurgery
Monash Medical Centre
246 Clayton Rd
Clayton, VIC, 3168
Country [1] 293453 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296025 0
Monash Health Human Research Ethics Committee Low Risk Review Panel
Ethics committee address [1] 296025 0
Ethics committee country [1] 296025 0
Australia
Date submitted for ethics approval [1] 296025 0
15/07/2015
Approval date [1] 296025 0
22/09/2015
Ethics approval number [1] 296025 0
15379L

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

Contacts
Principal investigator
Name 69286 0
A/Prof Tony Goldschlager
Address 69286 0
Department of Neurosurgery
Monash Medical Centre
246 Clayton Road
Clayton, VIC, 3168
Country 69286 0
Australia
Phone 69286 0
+61395945409
Fax 69286 0
Email 69286 0
[email protected]
Contact person for public queries
Name 69287 0
Chris Daly
Address 69287 0
Department of Neurosurgery
Monash Medical Centre
246 Clayton Road
Clayton, VIC, 3168
Country 69287 0
Australia
Phone 69287 0
+61395945409
Fax 69287 0
Email 69287 0
[email protected]
Contact person for scientific queries
Name 69288 0
Chris Daly
Address 69288 0
Department of Neurosurgery
Monash Medical Centre
246 Clayton Road
Clayton, VIC, 3168
Country 69288 0
Australia
Phone 69288 0
+61395945409
Fax 69288 0
Email 69288 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
EmbaseLumbar microdiscectomy and post-operative activity restrictions: A protocol for a single blinded randomised controlled trial.2017https://dx.doi.org/10.1186/s12891-017-1681-3
N.B. These documents automatically identified may not have been verified by the study sponsor.