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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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Surgery

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]

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]

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]

Six months

Secondary outcome [1]

Mean Visual Analogue Scale for leg pain- absolute and change scores

Timepoint [1]

Pre-operatively, Day 1 post-operatively, 1 month, 3months and 6 months

Secondary outcome [2]

Mean Visual Analogue Scale for lower back pain- absolute and change scores

Timepoint [2]

Pre-operatively, Day 1 post-operatively, 1 month, 3months and 6 months

Secondary outcome [3]

Oswestry Disability Index- absolute and change scores

Timepoint [3]

Pre-operatively, Day 1 post-operatively, 1 month, 3months and 6 months

Secondary outcome [4]

Disc Reherniation Rates- investigated upon clinical suspicion of recurrence with repeat MRI lumbar spine. Confirmed with repeat MRI Lumbar Spine.

Timepoint [4]

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]

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]

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?

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]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [2]

Cabrini Hospital - Malvern - Malvern

Recruitment hospital [3]

Casey Hospital - Berwick

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3144 - Malvern

Recruitment postcode(s) [3]

3806 - Berwick

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Cabrini Foundation

Address [1]

Cabrini Foundation
183 Wattletree Road
Malvern, VIC, 3144

Country [1]

Australia

Funding source category [2]

University

Name [2]

Monash University Department of Surgery

Address [2]

Department of Surgery
Monash Medical Centre
246 Clayton Rd
Clayton, VIC, 3168

Country [2]

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]

Individual

Name [1]

Dr Chris Daly

Address [1]

Department of Neurosurgery
Monash Medical Centre
246 Clayton Rd
Clayton, VIC, 3168

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee Low Risk Review Panel

Ethics committee address [1]

Monash Health Human Research Ethics Committee
Monash Medical Centre
246 Clayton Rd
Clayton, VIC, 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/07/2015

Approval date [1]

22/09/2015

Ethics approval number [1]

15379L

Summary

Brief summary

Lumbar discectomy is the most commonly performed spine surgical procedure.  Lumbar discectomy is performed to treat radicular pain (pain radiating along the distribution of a nerve) unresponsive to conservative management, neurological deficit or less commonly cauda equina syndrome.  Lumbar discectomy has evolved to a relatively minimally invasive surgical procedure performed as a day procedure in many centres in North America.  Traditionally surgeons have advised patients to restrict post-operative activity due to the hypothesis that this may reduce the risk of disc reherniation and progressive instability at the operated level.  In contemporary practice many surgeons do not advise any post-operative activity restriction.  Observational studies conducted to date investigating the effect of removal of activity restrictions demonstrated similar outcomes to those reported in the literature for traditional post-operative care.  No randomized controlled trial has been performed to investigate this question.


The purpose of this study is to directly compare in a randomized controlled trial patients following post-operative activity restrictions and those without post-operative activity restrictions for a period of one month following lumbar microdiscectomy.  Patients will undergo standard lumbar microdiscectomy and then be randomized into either the treatment (no restrictions) or control (restrictions groups).  For a period of one month following their procedure patients will wear an electronic monitoring device that will record activity and posture.  Patients will complete surveys pre-operatively and post-operatively at day one, one month, three months and six months.  Patients will also undergo clinical review at one month following their operation.  

The primary endpoint is a composite endpoint of change in visual analogue scale for pain (for back and legs), Oswestry Disability Index, absence of disc herniation recurrence or reintervention at six months.  Additional secondary endpoints will also be assessed.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Tony Goldschlager

Address

Department of Neurosurgery
Monash Medical Centre
246 Clayton Road
Clayton, VIC, 3168

Country

Australia

Phone

+61395945409

Fax

tony.goldschlager@monash.edu

Contact person for public queries

Name

Chris Daly

Address

Department of Neurosurgery
Monash Medical Centre
246 Clayton Road
Clayton, VIC, 3168

Country

Australia

Phone

+61395945409

Fax

christopher.daly@monash.edu

Contact person for scientific queries

Name

Chris Daly

Address

Department of Neurosurgery
Monash Medical Centre
246 Clayton Road
Clayton, VIC, 3168

Country

Australia

Phone

+61395945409

Fax

christopher.daly@monash.edu

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	Lumbar microdiscectomy and post-operative activity restrictions: A protocol for a single blinded randomised controlled trial.	2017	https://dx.doi.org/10.1186/s12891-017-1681-3

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