LUMBAR STENOSISStenosisNCT02879461
Surgical Decompression Associated With Physical Therapy and Physical Therapy Isolated in Patients With Lumbar Stenosis.
A study testing LUMBAR DESCOMPRESSION in people with LUMBAR STENOSIS, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- LUMBAR STENOSIS
- What is being tested?
- LUMBAR DESCOMPRESSION
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2015to 1 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- claudication Presence less than 100m ambulation;
- Pain in the lower limbs;
- Weakness in lower limbs;
- Burning in the lower limbs;
- Tingling in the lower limbs;
- Low back pain;
- the lower spinal canal area to 100mm2, at the discretion of Hamanishi.
Who cannot join
- decompensated diabetes mellitus;
- Systemic hypertension and decompensated heart disease;
- Systemic diseases to occur in the lower limbs;
- Neuromuscular diseases;
- Patients with previous surgery in the lumbar or thoracic spine;
- Cognitive impairment that interferes with the ability to understand or interpret the questionnaires;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Comparing Surgical Decompression Associated With Physical Therapy And Physical Therapy Isolated In Patients With Lumbar Canal Stenosis
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 .
Read more
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.
Read the detailed 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.
- 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
- 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.
- 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
- 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).
- 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 .
- 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.
- 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.
- Conditions
- LUMBAR STENOSIS
- Being tested
- LUMBAR DESCOMPRESSION
- Keywords
- SURGERY, REHABILITATION
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUMBAR DESCOMPRESSIONProcedure or surgery
Also called LUMBAR STENOSIS
ATRODESIS AND DESCOMPRESSIO OFF VERTEBRAL CANAL
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Decompression plus Physical Therapy | Active comparator | First group will be submitted to lumbar decompression L3 to S1 and physical therapy with exercise Application of questionnaires Oswestry Rolland moris Sf 36 Of 6minutos walk test Likert scale Use of paracetamol Receives: Procedure: LUMBAR DESCOMPRESSION |
| Physical Therapy | Active comparator | Second group physical therapy alone, with exercises Application of questionnaires Oswestry Rolland moris Sf 36 Of 6minutos walk test Likert scale Use of paracetamol Receives: Procedure: LUMBAR DESCOMPRESSION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Measured using the VAS
Measured: Baseline, after 4, 12, 24 and 48 weeks
Secondary outcomes (4)
Change in function
Measured using the Roland Morris questionnaire
Measured: Baseline, after 4, 12, 24 and 48 weeks
Change in function
Measured using the Oswestry questionnaire
Measured: Baseline, after 4, 12, 24 and 48 weeks
Change in walking distance
Measured using the six minute walking test
Measured: Baseline, after 4, 12, 24 and 48 weeks
Change in quality of life
Measured using the SF-36 questionnaire
Measured: Baseline, after 4, 12, 24 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start1 Jan 2015
- Primary completion1 Aug 2016
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LUMBAR STENOSISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Claudio Lacerda Rodrigues, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879461
- Sponsor's protocol ID
- 16127913.4.0000.5505
- Acronym
- Stenosis
- Status last verified
- Jan 2021
- First submitted
- 9 Aug 2016
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Rodrigues LCL, Natour J. Surgical treatment for lumbar spinal stenosis: a single-blinded randomized controlled trial. Adv Rheumatol. 2021 May 12;61(1):25. doi: 10.1186/s42358-021-00184-6.
PubMed 33980309
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Comparing Surgical Decompression Associated With Physical Therapy And Physical Therapy Isolated In Patients With Lumbar Canal Stenosis
- ClinicalTrials.gov ID
- NCT02879461
- Acronym / sponsor ID
- Stenosis / 16127913.4.0000.5505
- Conditions
- LUMBAR STENOSIS
- Keywords
- SURGERY, REHABILITATION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
- 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
- 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.
- 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
- 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).
- 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 .
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar Decompression plus Physical Therapy | Active comparator | Procedure: LUMBAR DESCOMPRESSIONFirst group will be submitted to lumbar decompression L3 to S1 and physical therapy with exercise Application of questionnaires Oswestry Rolland moris Sf 36 Of 6minutos walk test Likert scale Use of paracetamol |
| Physical Therapy | Active comparator | Procedure: LUMBAR DESCOMPRESSIONSecond group physical therapy alone, with exercises Application of questionnaires Oswestry Rolland moris Sf 36 Of 6minutos walk test Likert scale Use of paracetamol |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- claudication Presence less than 100m ambulation;
- Pain in the lower limbs;
- Weakness in lower limbs;
- Burning in the lower limbs;
- Tingling in the lower limbs;
Key exclusion criteria (6 listed)
- decompensated diabetes mellitus;
- Systemic hypertension and decompensated heart disease;
- Systemic diseases to occur in the lower limbs;
- Neuromuscular diseases;
- Patients with previous surgery in the lumbar or thoracic spine;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUMBAR DESCOMPRESSIONAlso: LUMBAR STENOSISATRODESIS AND DESCOMPRESSIO OFF VERTEBRAL CANAL | Procedure or surgery | Lumbar Decompression plus Physical Therapy, Physical Therapy |
Primary outcome
Change in Pain
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Measured using the VAS
4 secondary outcomes
Change in function
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Change in function
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Change in walking distance
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Change in quality of life
Time frame: Baseline, after 4, 12, 24 and 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Derived from this study: PubMed 33980309Rodrigues LCL, Natour J. Surgical treatment for lumbar spinal stenosis: a single-blinded randomized controlled trial. Adv Rheumatol. 2021 May 12;61(1):25. doi: 10.1186/s42358-021-00184-6.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUMBAR DESCOMPRESSION in people with LUMBAR STENOSIS, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: Baseline, after 4, 12, 24 and 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02879461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.