Primary Objective: To investigate whether small size interarcuair decompression is more effective than conventional laminectomy in patients with INC caused by LSS. Secondary Objective(s): To investigate whether small size interarcuair decompression…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
5.1.1 Main study parameter/endpoint
The primary outcome measurement will be the Modified Roland-Morris Disability
Questionnaire (MRMDQ). This is a 24-point Dutch questionnaire that is designed
to assess the physical disability in patients, due to lower back pain. The
participant will complete the questionnaire and the sum of the scores reflects
the invalidity in daily life. The score can vary from 0 (no restriction) to 24
(severe limitations).
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Secondary outcome
Numeric Rating Scale for leg and back pain
The pain intensity in both legs (affected and non-affected) and back will be
rated on an 11-point scale. A score of 0 represents *no pain*, while a score of
10 represents *the most terrible pain I can imagine*. The outcome is the
average pain intensity in the legs and back. During each visit the participants
are asked to rate the pain for both legs and one for back pain, if applicable.
The patient is not entitled to see the pain score indicated during previous
visit(s).
Physical examination consisting of:
- Neurologic examination
A straight leg raise test will be performed. Furthermore, strength, sensibility
and reflexes will be assessed of the lower extremity.
- Timed-up and go test
The TUG test will be performed in a standardized manner On *Go,* the patient
gets up and walks as fast as possible (no running) to a marked line on the
floor at a distance of 3*m. On the line, they turn around by 180° and return to
the chair and sit down as quickly as possible. The time between getting up and
sitting down again will be recorded in seconds using a stopwatch. The patients
are allowed to wear their regular shoes and use a walking aid, if required. Raw
TUG test times will be transformed into T-scores using age- and sex-adjusted
norms. The TUG app is validated for disc but not for stenosis yet and will be
conducted in this study.
- 6-minute walk test (6MinWT)
The 6 -minute walk test is performed to assess the gait pattern, walking speed
and physical endurance of patients. The test will be executed on a ground
level, where the walked distance can easily be measured, f.i. in a hall with
adequate walking space. The patient will be requested to walk at such a speed
that at the end of the 6 minutes, the patient will have the feeling of maximum
output. At the end of the 6 minutes, the distance will be measured. During the
walking test, the patient is permitted to use a walking aid and/or an orthosis.
- Timed Chair-Stand-Test (TCST)
The Timed Chair-Stand Test is a simple test to evaluate the muscle strength in
elderly patients. While conducting the TCST the patient is asked to stand up
from his chair and sit down as quickly as possible, for five times. The patient
is not allowed to use his arms during this test. The physician will record the
time in seconds.
Oswestry Disability Index 2.1a
The ODI is one of the principal condition-specific outcome measures used in the
management of spinal disorders. The current version of the ODI (2.1a) is to be
used. The ODI has been extensively tested, showing good psychometric
properties, and applicable in a wide variety of settings. There are 10
questions (items), each with 6 possible answers; each answer option receives a
score of 0 to 5 points, yielding score range between 0 and 50, which is scaled
to a 100% range. The questions are designed in a way to realize how the back or
leg pain is affecting the patient's ability to manage in everyday life.
Functional lumbar x-rays
A functional X-ray will be obtained from all patients X-ray will be made from
AP and lateral position to assess spondylolisthesis. Degenerative
spondylolisthesis is defined as a vertebral slip of at least 3 mm. This will
obtained after six weeks, for level verification and for verification of
correct procedure and after two years to look for possible instability of the
spine.
Likert scales for recovery and satisfaction with treatment
This will be measured using a seven-point Likert scale.
SF-36
The SF-36 has been applied and validated numerous times for intervention
studies involving vertebral column pathology. The questionnaire relates to the
analysis of the general functional status of the patient. The questions are
divided in 8 domains:
Per domain the scores of the items are added up and transformed into a scale of
0 to 100. A higher score reflects a better health condition.
• Physical functioning
• Physical role limitations
• Emotional role limitations
• Social functioning
• Physical pain
• General mental health
• Vitality
• General health perception
Complication and re-operation incidence
The neurosurgeon and research nurse will collect complications precisely. This
will be examined specifically in respect of:
• Infections, divided into superficial wound infections and deep wound
infections
• Post-surgical haematoma
• An increase in neurological failure due to surgery
• Blood transfusion
• Unintended durotomy
• Nerve injury
• Cardiovascular complications
• Pulmonary complications
• Wrong level surgery
• Wound infection
In numerous studies regarding vertebral column surgery re-operation is
considered as a very poor result of the initial surgery and therefore used as
effect measure
EuroQoL-5-dimension
The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of
the study. As indicated by the name, the tool measures five dimensions:
• Mobility
• Self-care
• Pain/discomfort
• Daily activities
• Anxiety
Each dimension consists of one item, in which three levels are distinguished
(no problems, some problems, many problems)
This tool provides the possibility to link the multidimensional description of
quality of life to a valuation (or utility). This utility may be linked to the
duration of the health situation in question. Together with the remaining life
expectation, they form QALY*s. The QALY is a measure for the number of years
that someone still may expect, corrected for their quality.
By measuring the utilities, a special type of cost effectiveness analysis is
created in which the measured measure is expressed in cost per QALY*s of one
treatment compared to the other, less effective treatment.
Together with the VAS, the EuroQol is an important result measure which will be
collected by the research nurse during each visit to the outpatient clinic on
the basis of the interview. The EuroQol is an effect measure that uses the
utilities of the general population and can easily be filled in at home. This
as opposed to the Time Trade Off and the SG which will neither be used in this
research, having the disadvantage of being complicated for most of the patients
and time-consuming for the research nurse.
Cost-diaries
The patient will be requested to keep a diary for the financial aspects of the
consequences of INC and corresponding treatment. The patient will be requested
to record the following items:
• Visits to GP
• Visits to physiotherapist
• Visits to specialist
• Alternative medicines and devices (e.g. rollator, etc.)
• Number of days of hospitalization
• Pain medication; dosage and frequency
• Illness-related days of absence at work, if any
• Cost of loss production and substitute manpower, if any
• Additional travelling expenses on account of INC
• Help in house holding
Background summary
Intermittent neurogenic claudication (INC) caused by a lumbar spinal canal
stenosis (LSS) is the most frequent reason for spinal surgery in the elderly.
Multiple, less invasive surgical techniques are applied without sufficient
evidence for benefits for patients or society.
The classic symptoms of INC are leg pain, which can be exacerbated with
prolonged walking and standing and/or lumbar extension, and is associated with
back pain. Severe stenosis is common in the elderly spine with 30.4% of the
population having severe stenosis. However, only 17.5% have complaints of INC.
Conservative treatment, such as physical therapy or pain medication, may give
some relief of symptoms. However, surgical treatment is considered to be the
gold standard for patients with INC caused by LSS. The first technique ever
described to widen the lumbar spinal canal is the wide bony decompression
(laminectomy), which is still a widely used technique. However, since INC is
often accompanied by back pain, and this to post-operative back pain, it is
hypothesized that a wide decompression is a ground for potential instability.
Hence, less invasive techniques, such as interarcuair decompression, were
developed and implemented.
Recent studies claim that a limited bony decompression is the new *golden
standard* therapy for patients with INC. Limited bony decompression is believed
to give less muscle damage and thus a faster postoperative recovery.
Furthermore, wide bony decompression (such as a laminectomy) is believed to
result in lumbar instability and iatrogenic scoliosis. Performing a procedure
with potential more complications in a - generally - elderly population could
at least be described as doubtful. The assumption is often made that after a
wide decompression recurrence of the complaints must be scarce. However, a
(cost-) effectiveness study, which evaluates the effectiveness of small bony
decompression compared to a *classical* extensive bony decompression, has not
been performed yet. The opinions on this matter are diverse. A laminectomy
involves the removal of more bone and structures at the back of the spine which
may result in longer hospitalization and loss of productivity, but it could
also lead to spinal instability on the long term. However, the risk of an
insufficient decompression may be higher, potentially leading to more
reoperations.
By the means of this double-blinded, multi-center randomized controlled trial
we will determine the (cost-) effectiveness of a limited bony decompression
compared to a wide bony decompression in patients with INC.
Study objective
Primary Objective: To investigate whether small size interarcuair
decompression is more effective than conventional laminectomy in patients with
INC caused by LSS.
Secondary Objective(s): To investigate whether small size interarcuair
decompression is more cost-effective than conventional laminectomy in patients
with INC caused by LSS.
Study design
The SIZE study is a researcher- and patient-blinded, multi-center randomized
controlled trial with superiority design and 1:1 allocation. The follow-up will
take place up to a duration of 48 months after surgery to investigate long-term
effect as well. A multicentre study is necessary to include the required number
of patients. All participating hospitals are individually responsible for the
treatment applied.
Demographic and clinical data will be collected during intake and follow-up
measurements. Patients will fill in patient-reported outcome measures via an
online research system (Gemstracker).
Intervention
All surgeons involved with the Size-study are highly experienced in both
interventions. Both techniques are part of the Dutch training program for
neurosurgeons.
The intervention that is to be investigated is the small size interarcuair
decompression by bilateral approach. A median lumbar incision is made over the
spinous process and the paravertebral muscles are dissected subperiosteally and
retracted bilaterally. Decompression will be applied via decompression of the
ligamentum flavum and partial laminectomy if necessary. The lateral recess will
be opened bilaterally and a medial facetectomy will be performed in order to
decompress the neuronal structures in the lateral recess. The wound will be
closed in layers with or without a suction drain. Patients will be operated
with a loupe magnification or microscope depending on the surgeon*s preference.
The usual care is a conventional laminectomy (Thome 2005). A median lumbar
incision is made over the spinous process and the paravertebral muscles are
dissected subperiosteally and retracted bilaterally. The supra and
interspinous ligament with the spinous process of the affected level are
removed and both laminae are removed totally at the affected level. The lateral
recess will be opened bilaterally and medial facetectomy will be performed in
order to decompress neuronal structures in the lateral recess. To clarify, when
a single level stenosis is present (e.g. L4-L5) both laminae L4 and L5 will be
removed and when a double level stenosis (e.g. L3-L4 and L4-L5) is present
three laminae (L3, L4 and L5) will be removed. The wound will be closed in
layers with or without a suction drain. Patients will be operated with loupe
magnification or microscope depending surgeon*s preference.
Study burden and risks
As the applied treatment will not differ from the usual care, participating
patients will neither benefit nor will they be at risk by participating in this
study regardless of the treatment they undergo as far as safety of surgical
procedures is concerned. Normally, a a patient would undergo a surgery
technique depending on the preference of the surgeon. During this study, the
technique, that is going to be used, depends on randomization, Other drawbacks
for participating include the extra time for completing the questionnaires,
visiting the research nurse and the additional risk of radiation due to
exposure during the X-rays.
s-Gravendijkwal 213 40
Rotterdam 3015CE
NL
s-Gravendijkwal 213 40
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
- At least 12 weeks of complaints of Intermittent Neurogenic Claudication
- Indication for an operation
- Magnetic Resonance Imaging demonstrating Lumbar Spinal Stenosis
- Age above 40 years
- Sufficient knowledge of the Dutch language in order comprehend the questionnaires and patient information.
- Written informed consent given
Exclusion criteria
- History of lumbar surgery
- More than 2 lumbar levels operation or needed discectomy
- Degenerative spondylolisthesis greater than grade I (on a scale of I to IV)
- Scoliosis or disc herniation
- Severe comorbid medical disorder (American Society of Anesthesiologists > 3)
- Serious psychopathologic disorder
- Pregnancy
- Active malignancy
- Plans to move abroad during study period.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03480893 |
| CCMO | NL65926.078.18 |