Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02879461 |
| Other study ID # |
16127913.4.0000.5505 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2015 |
| Est. completion date |
August 1, 2017 |
Study information
| Verified date |
January 2021 |
| Source |
Federal University of São Paulo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Stenosis of symptomatic lumbar canal is presented as a series of degenerative changes
affecting the various vertebral segment structures, including: a joint zigoapofisária, yellow
ligament, the articular capsule and the intervertebral disk. These changes decrease the area
of the spinal canal and press the neural structures and may present clinically as the narrow
tunnel syndrome.
This presentation was first described by Verbiest associated with these anatomical changes
the clinical manifestations; corresponding to low back pain, pain in the legs that worsen
with the fact ambulate and improve with rest, this presentation called neurogenic
claudication .
The lumbar canal stenosis was divided into two main types; congenital and acquired . The
first is associated with a reduced size of the pedicles, which leads to a reduction of the
diameter of the spinal canal, common in patients achondroplasics . The acquired is considered
the most common type and is associated with aging, including all anatomical structures of the
lumbar segment .
With an aging population the number of symptomatic patients is increasing, although there is
no statistic defined stenosis of symptomatic lumbar canal is the main reason for surgical
approaches to the spine in patients over 60 years of age (7).
As described by Daffner et al a reduction in blood flow leads to production of inflammatory
mediators, which associated with anatomical changes previously described lead to the clinical
picture with lameness and pain in the lower limbs Treatment of these patients is beginning
with guidance on the disease, adequate pain control, physical therapy and exercise for
maintaining the activities of daily living. If these measures fail a surgical approach may be
necessary, especially in patients with exercise intolerance, difficulty walking and urinary
incontinence .
The surgical approach despite being widely studied in the literature prospective controlled
studies are rare, found series of case studies or retrospective studies, we try to evaluate
the effectiveness of surgery compared to rehabilitation in symptomatic patients in an attempt
to assess the impact of surgery associated with comparing therapy with isolated therapy in
these patients.
Description:
Stenosis of symptomatic lumbar canal is presented as a series of degenerative changes
affecting the various vertebral segment structures, including: a joint zigoapofisária, yellow
ligament, the articular capsule and the intervertebral disk. These changes decrease the area
of the spinal canal and press the neural structures and may present clinically as the narrow
tunnel syndrome.
This presentation was first described by Verbiest associated with these anatomical changes
the clinical manifestations; corresponding to low back pain, pain in the legs that worsen
with the fact ambulate and improve with rest, this presentation called neurogenic
claudication .
The lumbar canal stenosis was divided into two main types; congenital and acquired . The
first is associated with a reduced size of the pedicles, which leads to a reduction of the
diameter of the spinal canal, common in patients achondroplasics . The acquired is considered
the most common type and is associated with aging, including all anatomical structures of the
lumbar segment .
With an aging population the number of symptomatic patients is increasing, although there is
no statistic defined stenosis of symptomatic lumbar canal is the main reason for surgical
approaches to the spine in patients over 60 years of age .
As described by Daffner et al a reduction in blood flow leads to production of inflammatory
mediators, which associated with anatomical changes previously described lead to the clinical
picture with lameness and pain in the lower limbs Treatment of these patients is beginning
with guidance on the disease, adequate pain control, physical therapy and exercise for
maintaining the activities of daily living. If these measures fail a surgical approach may be
necessary, especially in patients with exercise intolerance, difficulty walking and urinary
incontinence .
The surgical approach despite being widely studied in the literature prospective controlled
studies are rare, found series of case studies or retrospective studies, we try to evaluate
the effectiveness of surgery compared to rehabilitation in symptomatic patients in an attempt
to assess the impact of surgery associated with comparing therapy with isolated therapy in
these patients.
2.OBJETIVOS The aim of this study is to evaluate the effectiveness of surgical approach
associated with physiotherapy compared with physiotherapy alone in the quality of life in the
lumbar narrow tunnel syndrome.
Secondary objectives: to evaluate the influence of physical therapy on muscle gain and
improves the conditioning of these patients.
To evaluate the incidence of complications in patients undergoing surgical approach.
3. PATIENTS AND METHODS
3.1 - Delineation Our research contains a controlled prospective, randomized and blinded to
the evaluator that evaluates the effectiveness of the surgical approach more physical therapy
associated with isolated physical therapy in symptomatic lumbar spinal stenosis.
3.2 - Patients As research subjects will be randomized 62 patients through board electronic
randomization ..
They will be included patients aged 50 to 75 years, of both genders, who agreed to
participate in the work, having previously agreed to sign the consent form. Patients will be
subject to an anthropometric assessment, with altitude record, weight and presence of
associated comorbidities.
After the initial evaluation, patients will be randomized, with a group that will undergo
surgery and after 3 weeks postoperatively initiated a rehabilitation program, a second group
will be isolated physiotherapy. As an evaluation factor, also you will be given a bottle of
paracetamol 750 mg and dated sheet, which will be instructed to register the day and the
number of capsules taken for a period of 90 days.
3.3 - Clinical diagnosis In the clinical diagnosis of the case was the presence of
claudication under walk 100m and at least two of the following complaints in lower limb pain,
weakness, burning or tingling that worsens with walking and improves with the stop of
ambulation and may or may not It is associated with low back pain.
3.4 - Radiological diagnosis In our study, the presence of lumbar canal stenosis was
considered with an area less than 100mm2, based on criteria Hamanishi measured on MRI of the
lumbar spine in follow-L3 to S1.
All patients underwent MRI on a device of 1 Tesla (Philips, Giroscan) belonging to the image
of Hospital Santa Marcelina, SP. The test was done with the patient supine and cushion on his
knees to maintain flexion of the hip and knee.
To avoid bias in the channel area due to the angle, all the cuts were made parallel to the
discs, being accepted a difference of angle of at most 5.
The calculation was based on mathematical values, as follows: we calculated the laterolateral
diameter (a) and anteroposterior (b) where the major axis whose data were provided by
computer program (OSIRIX® 2010) on the scanned image. In case there were any differences, the
figures would be recalculated and decided whether, then, for an average value between the
measures. After calculating these values were divided by two, individually and multiplied by
the value π (PI) . The obtained result is multiplied by a constant ranging from 0.8 (when the
channel was circular), 0.7 (where the channel was elliptical), in the presence of 0.6 and 0.5
facet compression, when compression was made by the disc and the facets. Thus, (a / 2) x (b /
2) x π (constant) .
3.5 - Intervention
After the patient's initial assessment and the same take part in the study. Will be
randomized in one of the groups the 1st group will be associated with decompression with
arthrodesis implant placement type pedicle screws, are included patients requiring
decompression of up to three levels. After three weeks of surgical treatment the patient
started a rehabilitation program with physiotherapy assistance with weekly frequency for a
period of 12 weeks.
The second group is subjected to a rehabilitation program isolated identical to the 1st group
for 12 weeks.
Both groups will be offered 750 mg of paracetamol for up to 3 taken daily for 90 days. The
evaluations will be carried out at the time of inclusion in the project, and the patient who
undergoes surgery had performed surgery the following week after the assessment. The second
evaluation will be conducted 4 weeks after, in both groups, this evaluation will be conducted
to compare the muscle losses after surgery. The following evaluations will be performed in
T12, 12 weeks after the start of rehabilitation, 24 and 48 weeks after the start of
rehabilitation.
They will be also evaluated the incidence of complications in patients undergoing surgery.
Patients who are on medical treatment and opt for surgical treatment may do so at any time of
the study.
As an auxiliary method of evaluation will be made a mensuramento the quadriceps diameter and
sural triceps at all owner?.
3.6 - Assessment tools
1. Visual Analog Scale (VAS): instrument subjectively assesses the pain using a visual
analog scale, in which the patient quantifies the degree of their pain following a line
of 0 to 10 cm, with 0 being no pain and 10 unbearable pain (FERRAZ, 1990). The patient
was asked about the pain he felt to walk last week.
2. Roland-Morris is extracted questionnaire physical component of the Sickness Impact
Profile, plus in each question, the phrase "because of my back." This questionnaire
consists of 24 questions relevant to the daily lives of individuals with low back pain,
easy application, applied in less than 5 minutes and immediately score
3. 6-minute walk test: used to evaluate the functional capacity of the patient. The test
was performed on a track of 22 meters traveled at a maximum speed achieved by the
patient for six minutes following the guidelines of the American Thoracic Society
(American Toracic Society (ATS) Committee on Proficiency Standards for Clinical
Pulmonary Function Laboratories).
4. Short Form SF36: generic instrument to assess quality of life, translated from English
into Portuguese and validated with 36 questions divided into eight areas. In this
questionnaire are discussed aspects related to functional capacity, limitations on
physical aspects, pain, general health, vitality, social functioning, emotional aspects
and mental health. The score ranges from zero to one hundred, zero being the worst
health condition, and one hundred the best .
5. Scale Likert: It is a psychometric scale commonly used in questionnaires where the
patient reports his opinion directly, according to their view of treatment: much better,
somewhat better, not better, just worse and worse.
6. Disability Index Oswestry The ODI is used for functional evaluation of the lumbar spine,
incorporating measures of pain and activity. The scale consists of 10 questions six
alternatives, whose value ranges from 0 to 5.
3.7 - Calculation of n. Considering a 80% power and 5% significance, to compare VAS between
the two groups at 5 different times, considering a standard deviation equal to 2 and a
minimum difference between the measures equal to 2, it took 31 individuals in each group to
greater certainty as to the validity of the results.
