Lumbar Spinal StenosisNCT04273828
Impact of Muscle Degeneration in Chronic Low Back Pain
An observational study of Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
Surgical interventions for the removal of intervertebral disc fragments or to enlarge a narrow spine canal are commonly performed worldwide and are considered efficient. Concomitant low back pain is not uncommon among patients with lumbar nerve compression and neurological symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Radiculopathy
- What is being tested?
- Lumbar decompressive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 168 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Apr 2020to 27 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted at the Israelita Albert Einstein Hospital (HIAE), a tertiary private philanthropic hospital located in the city of São Paulo, Brazil. All participants will be from and treated at the institution's spine surgery outpatient clinics.
Who may be able to join
- adults 18 years of age and older;
- with symptoms of lumbosacral neural compression (radiculopathy or neurogenic lameness);
- failed conservative treatment for at least 6 weeks;
- undergoing surgery for neural decompression (discectomy and / or foraminotomy and / or hemilaminectomy);
- with complete pre and postoperative medical records in all evaluations.
Who cannot join
- need for lumbar arthrodesis;
- deep infection requiring surgical cleaning;
- patients submitted to joint facet rhizotomy;
- active rheumatologic disease, including seronegative arthropathies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05601-901
About this study
Official title: Impact of Muscle Degeneration in Chronic Ow Back Pain in Patients Undergoing Neural Decompression
Surgical interventions for the removal of intervertebral disc fragments or to enlarge a narrow spine canal are commonly performed worldwide and are considered efficient. Concomitant low back pain is not uncommon among patients with lumbar nerve compression and neurological symptoms. When present, controversy persists in the literature regarding its ideal management. Although neurological symptoms improve after decompressive surgery, the presence of residual chronic low back pain may worsen satisfaction scores and cause functional disability.
The hypothesis of the present study is that the presence of atrophy of the paraspinal and trunk muscles predicts chronic low back pain after lumbar neural decompression. If confirmed, this finding will aid in better planning of physical rehabilitation strategies for this group of patients, as well as a clearer prediction regarding surgical treatment outcomes for patients and health professionals.
Read the detailed description
This is a prospective cohort study. Patients with lumbar degenerative diseases and symptoms of nerve compression (radiculopathy or neurogenic claudication) who will undergo surgical treatment for neural decompression (discectomy, foraminotomy or laminectomy).
The cohort will be followed by a team researcher (not blinded to the purpose of the study) at preoperative (up to 1 month before surgery), immediate postoperative (12 to 24 hours after procedure), 06, 12 and 24 months after surgery. Imaging tests will be performed on the preoperative evaluation and at six months follow-up after the operation.
The treatment will consist of lumbar decompression surgery, which may consist of discectomy, foraminotomy or laminectomy, according to the type and location of the compression. The choice of surgical technique will be made by the assistant surgeon.
Patients will be divided into four groups regarding the type of soft tissue retractor and image magnification:
Group 1: (minimally invasive microdiscectomy): surgeries performed with loupes or microscope plus minimally invasive soft tissue retractors (tubular or "Caspar").
Group 2: (open microdiscectomy) surgeries performed with loupes or microscope plus conventional soft tissue retractors (auto static, "Taylor" or "McCulloch").
Group 3: (endoscopic discectomy): surgeries performed by means of the "full endoscopic" technique;
Group 4: (open discectomy "with the naked eye"): surgeries performed without image magnification. Use of conventional soft tissue retractors (auto static, "Taylor" or "McCulloch").
Image Evaluation:
- X-Rays (anteroposterior, lateral, dynamic lateral films) - to evaluate and measure the presence of scoliosis, spondylolisthesis or Degenerative vertebral dislocations.
- MRI: to detect and to grade the presence of fat infiltration of the Psoas and Multifidus muscles (Arabanas et al); to grade Modic Signal and facet joint degeneration (Weishaupt et al).
Sample size:
For the sample size estimation, we considered the main outcome of the study, a 1.5-point change in the pain scale (VAS) among patients with fat infiltration (grades 1, 2, or 3) and without fat infiltration (grade 0), after 6 months of spine surgery, with 80% power and 95% confidence, the sample required for the study is 28 patients in each group considering a two-tailed test. Similarly to the previous study, we observed that the first 14 patients in the pilot study, 20% of patients had without fat infiltration, therefore, as the admission of patients into the study is consecutive, we expect to find this same percentage of patients without fat infiltration in the final sample of patients, so 140 patients are needed to get 28 patients without fat infiltration. Predicting a loss of 20% of patients at 6 months of follow-up, the initial sample to be considered will be 168 patients to obtain the minimum number of patients required in each group.
Statistics:
Numerical variables with normal distribution will be described by means and standard deviations and variables with non-normal distribution by medians and interquartile ranges, in addition to the minimum and maximum values. The distributions of numerical variables will be verified by histograms, boxplots, and, if necessary, Shapiro-Wilk normality tests. Categorical variables will be described by absolute frequencies and percentages. The analyzes will be performed with the SPSS26 program, considering a 5% significance level.
- Being tested
- Lumbar decompressive surgery
- Keywords
- back pain, lumbar disc herniation, lumbar spinal stenosis, Decompression, surgical
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Displacement, Radiculopathy, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar decompressive surgeryProcedure or surgery
Patients with lumbar degenerative diseases and symptoms of nerve compression (radiculopathy or neurogenic claudication) who will undergo surgical treatment for neural decompression (discectomy, foraminotomy or laminectomy).
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Pain intensity will be measured using VAS 0-10 (0 being no pain and 10 maximum pain)
Measured: Baseline, 3, 6, 12 and 24 months after surgery
Secondary outcomes (7)
Radiological evaluation
Magnetic resonance imaging (MRI) reading parameters of Paravertebral and Psoas major fat tissue infiltration follow the standardized institutional protocol for spine evaluation.
Measured: Baseline and 6 month after surgery
Change in Kinesiophobia
Assessment of fear avoidance beliefs related to physical activity and work will be evaluated by the questionnaire Fear avoidance Beliefs Questionnaire (FABQ)
Measured: Baseline, 3, 6, 12 and 24 months after surgery
Change in Psychosocial Risk Prognosis
Psychosocial risk prognosis will be measured by the brazilian version of the STarT Back screening tool.
Measured: Baseline, 3, 6, 12 and 24 months after surgery
Change in Global Impression of Recovery
Global impression of recovery will be measured by the Global Perceived Effect of Change(GPE)
Measured: Baseline, 3, 6, 12 and 24 months after surgery
Change in Mood Disorders in The setting of Medical Practice
Anxiety and depression aspects will be measured by the Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline, 3, 6, 12 and 24 months after surgery
Change in Disability
Disability will be measured by the Oswestry Disability Index, Brazilian version 2.0.
Measured: Baseline, 3, 6, 12 and 24 months after surgery
Change in Quality life
EuroQoL will be combined with a Visual Analogue Scale(VAS) to carry out the cost-effectiveness analysis of the second opinion program.
Measured: Baseline, 3, 6, 12 and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start6 Apr 2020
- Primary completion27 Dec 2024
- Study completion27 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Gotfryd, PhD, Principal investigator, Phisician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273828
- Sponsor's protocol ID
- 94868618.7.0000.0071
- Status last verified
- Nov 2024
- First submitted
- 11 Feb 2020
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bae HW, Rajaee SS, Kanim LE. Nationwide trends in the surgical management of lumbar spinal stenosis. Spine (Phila Pa 1976). 2013 May 15;38(11):916-26. doi: 10.1097/BRS.0b013e3182833e7c.
PubMed 23324922Kovacs FM, Urrutia G, Alarcon JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa 1976). 2011 Sep 15;36(20):E1335-51. doi: 10.1097/BRS.0b013e31820c97b1.
PubMed 21311394Jacobs WC, van Tulder M, Arts M, Rubinstein SM, van Middelkoop M, Ostelo R, Verhagen A, Koes B, Peul WC. Surgery versus conservative management of sciatica due to a lumbar herniated disc: a systematic review. Eur Spine J. 2011 Apr;20(4):513-22. doi: 10.1007/s00586-010-1603-7. Epub 2010 Oct 15.
PubMed 20949289Bydon M, De la Garza-Ramos R, Macki M, Baker A, Gokaslan AK, Bydon A. Lumbar fusion versus nonoperative management for treatment of discogenic low back pain: a systematic review and meta-analysis of randomized controlled trials. J Spinal Disord Tech. 2014 Jul;27(5):297-304. doi: 10.1097/BSD.0000000000000072.
PubMed 24346052Hansen L, de Zee M, Rasmussen J, Andersen TB, Wong C, Simonsen EB. Anatomy and biomechanics of the back muscles in the lumbar spine with reference to biomechanical modeling. Spine (Phila Pa 1976). 2006 Aug 1;31(17):1888-99. doi: 10.1097/01.brs.0000229232.66090.58.
PubMed 16924205Freeman MD, Woodham MA, Woodham AW. The role of the lumbar multifidus in chronic low back pain: a review. PM R. 2010 Feb;2(2):142-6; quiz 1 p following 167. doi: 10.1016/j.pmrj.2009.11.006.
PubMed 20193941Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.
PubMed 10872758von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008.
PubMed 18313558Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-52. doi: 10.1016/s0039-6109(05)70381-9.
PubMed 10352653Vigatto R, Alexandre NM, Correa Filho HR. Development of a Brazilian Portuguese version of the Oswestry Disability Index: cross-cultural adaptation, reliability, and validity. Spine (Phila Pa 1976). 2007 Feb 15;32(4):481-6. doi: 10.1097/01.brs.0000255075.11496.47.
PubMed 1730414111. Herdman M, Fox-Rushby J, Rabin R, Badia X, Selai C. Producing other language versions of the EQ-5D. In: Brooks R, Rabin R, de Charro F (eds). The measurement and valuation of health status using EQ-5D: A European perspective. Kluwer Academic Publishers 2003.
Abreu AM, Faria CD, Cardoso SM, Teixeira-Salmela LF. [The Brazilian version of the Fear Avoidance Beliefs Questionnaire]. Cad Saude Publica. 2008 Mar;24(3):615-23. doi: 10.1590/s0102-311x2008000300015. Portuguese.
PubMed 18327449Pilz B, Vasconcelos RA, Marcondes FB, Lodovichi SS, Mello W, Grossi DB. The Brazilian version of STarT Back Screening Tool - translation, cross-cultural adaptation and reliability. Braz J Phys Ther. 2014 Sep-Oct;18(5):453-61. doi: 10.1590/bjpt-rbf.2014.0028. Epub 2014 Aug 29.
PubMed 25372008Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008 Oct 15;33(22):2459-63. doi: 10.1097/BRS.0b013e3181849dbe.
PubMed 18923324Marcolino JA, Mathias LA, Piccinini Filho L, Guaratini AA, Suzuki FM, Alli LA. Hospital Anxiety and Depression Scale: a study on the validation of the criteria and reliability on preoperative patients. Rev Bras Anestesiol. 2007 Feb;57(1):52-62. doi: 10.1590/s0034-70942007000100006. English, Portuguese.
PubMed 19468618
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Muscle Degeneration in Chronic Ow Back Pain in Patients Undergoing Neural Decompression
- ClinicalTrials.gov ID
- NCT04273828
- Acronym / sponsor ID
- 94868618.7.0000.0071
- Keywords
- back pain, lumbar disc herniation, lumbar spinal stenosis, Decompression, surgical
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Jun 2025 (estimated)
- First posted
- 18 Feb 2020 (actual)
- 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.
Surgical interventions for the removal of intervertebral disc fragments or to enlarge a narrow spine canal are commonly performed worldwide and are considered efficient. Concomitant low back pain is not uncommon among patients with lumbar nerve compression and neurological symptoms. When present, controversy persists in the literature regarding its ideal management. Although neurological symptoms improve after decompressive surgery, the presence of residual chronic low back pain may worsen satisfaction scores and cause functional disability.
The hypothesis of the present study is that the presence of atrophy of the paraspinal and trunk muscles predicts chronic low back pain after lumbar neural decompression. If confirmed, this finding will aid in better planning of physical rehabilitation strategies for this group of patients, as well as a clearer prediction regarding surgical treatment outcomes for patients and health professionals.
Detailed description
This is a prospective cohort study. Patients with lumbar degenerative diseases and symptoms of nerve compression (radiculopathy or neurogenic claudication) who will undergo surgical treatment for neural decompression (discectomy, foraminotomy or laminectomy).
The cohort will be followed by a team researcher (not blinded to the purpose of the study) at preoperative (up to 1 month before surgery), immediate postoperative (12 to 24 hours after procedure), 06, 12 and 24 months after surgery. Imaging tests will be performed on the preoperative evaluation and at six months follow-up after the operation.
The treatment will consist of lumbar decompression surgery, which may consist of discectomy, foraminotomy or laminectomy, according to the type and location of the compression. The choice of surgical technique will be made by the assistant surgeon.
Patients will be divided into four groups regarding the type of soft tissue retractor and image magnification:
Group 1: (minimally invasive microdiscectomy): surgeries performed with loupes or microscope plus minimally invasive soft tissue retractors (tubular or "Caspar").
Group 2: (open microdiscectomy) surgeries performed with loupes or microscope plus conventional soft tissue retractors (auto static, "Taylor" or "McCulloch").
Group 3: (endoscopic discectomy): surgeries performed by means of the "full endoscopic" technique;
Group 4: (open discectomy "with the naked eye"): surgeries performed without image magnification. Use of conventional soft tissue retractors (auto static, "Taylor" or "McCulloch").
Image Evaluation:
- X-Rays (anteroposterior, lateral, dynamic lateral films) - to evaluate and measure the presence of scoliosis, spondylolisthesis or Degenerative vertebral dislocations.
- MRI: to detect and to grade the presence of fat infiltration of the Psoas and Multifidus muscles (Arabanas et al); to grade Modic Signal and facet joint degeneration (Weishaupt et al).
Sample size:
For the sample size estimation, we considered the main outcome of the study, a 1.5-point change in the pain scale (VAS) among patients with fat infiltration (grades 1, 2, or 3) and without fat infiltration (grade 0), after 6 months of spine surgery, with 80% power and 95% confidence, the sample required for the study is 28 patients in each group considering a two-tailed test. Similarly to the previous study, we observed that the first 14 patients in the pilot study, 20% of patients had without fat infiltration, therefore, as the admission of patients into the study is consecutive, we expect to find this same percentage of patients without fat infiltration in the final sample of patients, so 140 patients are needed to get 28 patients without fat infiltration. Predicting a loss of 20% of patients at 6 months of follow-up, the initial sample to be considered will be 168 patients to obtain the minimum number of patients required in each group.
Statistics:
Numerical variables with normal distribution will be described by means and standard deviations and variables with non-normal distribution by medians and interquartile ranges, in addition to the minimum and maximum values. The distributions of numerical variables will be verified by histograms, boxplots, and, if necessary, Shapiro-Wilk normality tests. Categorical variables will be described by absolute frequencies and percentages. The analyzes will be performed with the SPSS26 program, considering a 5% significance level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted at the Israelita Albert Einstein Hospital (HIAE), a tertiary private philanthropic hospital located in the city of São Paulo, Brazil. All participants will be from and treated at the institution's spine surgery outpatient clinics.
Key inclusion criteria (5 listed)
- adults 18 years of age and older;
- with symptoms of lumbosacral neural compression (radiculopathy or neurogenic lameness);
- failed conservative treatment for at least 6 weeks;
- undergoing surgery for neural decompression (discectomy and / or foraminotomy and / or hemilaminectomy);
- with complete pre and postoperative medical records in all evaluations.
Key exclusion criteria (4 listed)
- need for lumbar arthrodesis;
- deep infection requiring surgical cleaning;
- patients submitted to joint facet rhizotomy;
- active rheumatologic disease, including seronegative arthropathies.
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 decompressive surgeryPatients with lumbar degenerative diseases and symptoms of nerve compression (radiculopathy or neurogenic claudication) who will undergo surgical treatment for neural decompression (discectomy, foraminotomy or laminectomy). | Procedure or surgery | – |
Primary outcome
Change in Pain Intensity
Time frame: Baseline, 3, 6, 12 and 24 months after surgery
Pain intensity will be measured using VAS 0-10 (0 being no pain and 10 maximum pain)
7 secondary outcomes
Radiological evaluation
Time frame: Baseline and 6 month after surgery
Change in Kinesiophobia
Time frame: Baseline, 3, 6, 12 and 24 months after surgery
Change in Psychosocial Risk Prognosis
Time frame: Baseline, 3, 6, 12 and 24 months after surgery
Change in Global Impression of Recovery
Time frame: Baseline, 3, 6, 12 and 24 months after surgery
Change in Mood Disorders in The setting of Medical Practice
Time frame: Baseline, 3, 6, 12 and 24 months after surgery
Change in Disability
Time frame: Baseline, 3, 6, 12 and 24 months after surgery
Change in Quality life
Time frame: Baseline, 3, 6, 12 and 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 23324922Bae HW, Rajaee SS, Kanim LE. Nationwide trends in the surgical management of lumbar spinal stenosis. Spine (Phila Pa 1976). 2013 May 15;38(11):916-26. doi: 10.1097/BRS.0b013e3182833e7c.
- Background: PubMed 21311394Kovacs FM, Urrutia G, Alarcon JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa 1976). 2011 Sep 15;36(20):E1335-51. doi: 10.1097/BRS.0b013e31820c97b1.
- Background: PubMed 20949289Jacobs WC, van Tulder M, Arts M, Rubinstein SM, van Middelkoop M, Ostelo R, Verhagen A, Koes B, Peul WC. Surgery versus conservative management of sciatica due to a lumbar herniated disc: a systematic review. Eur Spine J. 2011 Apr;20(4):513-22. doi: 10.1007/s00586-010-1603-7. Epub 2010 Oct 15.
- Background: PubMed 24346052Bydon M, De la Garza-Ramos R, Macki M, Baker A, Gokaslan AK, Bydon A. Lumbar fusion versus nonoperative management for treatment of discogenic low back pain: a systematic review and meta-analysis of randomized controlled trials. J Spinal Disord Tech. 2014 Jul;27(5):297-304. doi: 10.1097/BSD.0000000000000072.
- Background: PubMed 16924205Hansen L, de Zee M, Rasmussen J, Andersen TB, Wong C, Simonsen EB. Anatomy and biomechanics of the back muscles in the lumbar spine with reference to biomechanical modeling. Spine (Phila Pa 1976). 2006 Aug 1;31(17):1888-99. doi: 10.1097/01.brs.0000229232.66090.58.
- Background: PubMed 20193941Freeman MD, Woodham MA, Woodham AW. The role of the lumbar multifidus in chronic low back pain: a review. PM R. 2010 Feb;2(2):142-6; quiz 1 p following 167. doi: 10.1016/j.pmrj.2009.11.006.
- Background: PubMed 10872758Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.
- Background: PubMed 18313558von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr;61(4):344-9. doi: 10.1016/j.jclinepi.2007.11.008.
- Background: PubMed 10352653Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-52. doi: 10.1016/s0039-6109(05)70381-9.
- Background: PubMed 17304141Vigatto R, Alexandre NM, Correa Filho HR. Development of a Brazilian Portuguese version of the Oswestry Disability Index: cross-cultural adaptation, reliability, and validity. Spine (Phila Pa 1976). 2007 Feb 15;32(4):481-6. doi: 10.1097/01.brs.0000255075.11496.47.
- Background11. Herdman M, Fox-Rushby J, Rabin R, Badia X, Selai C. Producing other language versions of the EQ-5D. In: Brooks R, Rabin R, de Charro F (eds). The measurement and valuation of health status using EQ-5D: A European perspective. Kluwer Academic Publishers 2003.
- Background: PubMed 18327449Abreu AM, Faria CD, Cardoso SM, Teixeira-Salmela LF. [The Brazilian version of the Fear Avoidance Beliefs Questionnaire]. Cad Saude Publica. 2008 Mar;24(3):615-23. doi: 10.1590/s0102-311x2008000300015. Portuguese.
- Individual participant dataSharing planned: Undecided
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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.
Alberto Gotfryd, PhD principal investigator
Phisician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by Hospital Israelita Albert Einstein 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Gotfryd, PhD (5511995925225, albertocoluna@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Baseline, 3, 6, 12 and 24 months after surgery). 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 NCT04273828, which also lists 22 linked publications.
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 13 Mar 2025.