Low Back PainNCT03082248
Second Opinion in Spinal Surgery Indications: Cost-Effectiveness Evaluation
A study testing Physical Therapy and Spinal Surgery in people with Low Back Pain and Lumbar Spine Injury, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
Low back pain is a common symptom, which often affects the adult population. Studies show that over the past two decades, costs related to spinal surgery have increased significantly, leading to speculation about what would be motivating this phenomenon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Lumbar Spine Injury
- What is being tested?
- Physical Therapy and Spinal Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2018to 30 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with surgery indication (referred by the health care provider) for the treatment of degenerative diseases of the lumbar spine (basically: intervertebral disc disease, degenerative spondylolisthesis, lumbar canal stenosis, facet low back pain and lumbar instability);
- no contraindication to general anesthesia or any physiotherapeutic procedure;
- able to understand Portuguese language and after acceptance of a written consent.
Who cannot join
- Patients with:
- spinal fractures;
- scoliosis greater than 20 degrees;
- congenital deformities;
- spinal tumors;
- confirmed or suspected pregnancy;
- history of previous surgery in the spine; and,
- unable to participate in the follow-up (due to inability to read or complete the required forms).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-000
About this study
Low back pain is a common symptom, which often affects the adult population. Studies show that over the past two decades, costs related to spinal surgery have increased significantly, leading to speculation about what would be motivating this phenomenon. Although expenses with physical therapy treatments and less invasive surgical procedures remained relatively stable, the amount spent with more complex spine surgeries increased exponentially until they became the procedures with the highest costs in healthcare. The criteria for surgical indication are not uniform among surgeons and therefore a study of second opinion in spine surgeries is urgently needed. The present study aims to 1) quantify cost-effectiveness of second opinion for patients with spinal surgery indication 2) evaluate effectiveness of conservative and surgical treatment for degenerative diseases of the lumbar spine 3) define objective criteria for indication of conservative and surgical treatment using evidence-based medicine 4) evaluate prognosis of biological markers in the follow-up of patients with lumbar affections 5) evaluate interobserver agreement of physicians in relation to the diagnoses and treatment proposals in patients with diseases of the lumbar spine 6) verify effectiveness of patients who were operated on, compared to patients who were not operated. A prospective cohort study will be conducted, in which patients with an indication of surgical spinal treatment will be evaluated for a second opinion. First evaluation diagnoses and indications for patient treatment will be compared with the second opinion evaluation. All patients who choose to participate on the study will be followed up for a year for evaluations concerning cost-effectiveness, pain, quality of life, function and blood biomarkers. The outcomes will be compared using linear or generalized mixed models and descriptive analyzes of the study population program will be carried out; Statistical agreement will be observed between the first and second opinion and also patient acceptance rates for the treatment proposed in the second indication, evaluating the validity of the project approach. A five-year budget impact analysis will also be carried out, taking into account the population who was eligible for treatment according to the admission flow of a private outpatient setting.
Read the detailed description
The present study could provide benefits to all aspects of treatment approaches involved in patients with low back pain: for the entire medical community by presenting better information about the actual surgical indications for patients with low back pain; for health insurers and in general, who can spend their investments in really effective areas, and especially for patients, who will receive appropriate treatments for their conditions.
190 patients with indication of surgical treatment will be enrolled for this clinical trial and will be advised to receive a second opinion at Hospital Israelite Albert Einstein (HIAE).
Both assessments (with orthopedic physicians) will be compared, and when consensus is reached about diagnostic hypotheses and treatment, patients will be referred for conservative or surgical treatment. Any disagreements will be resolved by a committee of spine surgeons (four orthopedists and four neurosurgeons with more than 15 years of experience).
When the treatment chosen for the first medical care (two consultations of the orthopedic surgeons) is the conservative treatment, patients will be referred to consultations in the rehabilitation center. When surgical treatment is indicated, the patient will be referred to one of the eight surgeons of the spinal committee.
All patients will have the freedom of choice to decide to participate in the study guided by the second opinion service or perform the recommended treatment in the first hospital in which they were treated.
Sample size: For the calculation of the sample size estimate, we considered data presented in the study by van der Roer et al. (2006), in which the mean score obtained by the EuroQol instrument in pre-treatment patients was 0.70 in chronic patients, with standard deviation of 0.19. Assuming that the correlation between the measurements obtained at the two main moments of comparison (baseline and after 10 weeks of treatment) is of the order of 0.5 and that the minimally relevant difference between the two moments is 0.07, we estimate that 90 patients should be considered in the conservative treatment group. Assuming that of the patients who use the second opinion service about 55% will perform surgical procedures in the service, we estimate that 100 patients should be included in this group. Sample size estimates were performed with the statistical package STATA version 10.0, considering 90% power and 5% level of significance.
- Conditions
- Low Back Pain, Lumbar Spine Injury
- Being tested
- Physical Therapy, Spinal Surgery
- Keywords
- Low Back Pain, Surgery, Lumbar Spine, Physical Therapy Modalities, Rehabilitation
- Medical subject headings
- Low Back Pain, Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Patients allocated to the conservative treatment group will receive physical therapy according to the treatment-based classification approach and also educational leaflets and folders.
Spinal SurgeryProcedure or surgery
Patients allocated to the surgical procedure group will undergo spinal surgery procedures and techniques specific for the low back region.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy Group | Other | 10-week supervised physiotherapeutic intervention; all patients will receive educational leaflets and folders for maintenance and adherence to the treatment program. Receives: Other: Physical Therapy |
| Spinal Surgery Group | Other | Surgical procedures and techniques specific for the low back region, previously discussed and agreed upon among surgeons according to patients description. Receives: Procedure: Spinal Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost Effectiveness analysis
EuroQoL will be combined with a Visual Analogue Scale(VAS) to carry out the cost-effectiveness analysis of the second opinion program.
Measured: 12 months after treatment
Secondary outcomes (6)
Change in Pain Intensity
Pain intensity will be measured using VAS 0-10 (0 being no pain and 10 maximum pain)
Measured: 1, 3, 6 and 12 months after treatment
Change in Disability
Disability will be measured by the Oswestry Disability Index, Brazilian version 2.0.
Measured: 1, 3, 6 and 12 months after treatment
Change in Global Impression of Recovery
Global impression of recovery will be measured by the Global Perceived Effect of Change(GPE)
Measured: 1, 3, 6 and 12 months after treatment
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: 1, 3, 6 and 12 months after treatment
Change in Psychosocial Risk Prognosis
Psychosocial risk prognosis will be measured by the brazilian version of the STarT Back screening tool
Measured: 1, 3, 6 and 12 months after treatment
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: 1, 3, 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Sep 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Ferretti, MD, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082248
- Sponsor's protocol ID
- Low Back Pain
- Status last verified
- Jul 2018
- First submitted
- 3 Mar 2017
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are happy to share our data with researchers that would like to use it on an individual participant data
Publications
Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, Sullivan SD. Expenditures and health status among adults with back and neck problems. JAMA. 2008 Feb 13;299(6):656-64. doi: 10.1001/jama.299.6.656.
PubMed 18270354Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008 Jan-Feb;8(1):8-20. doi: 10.1016/j.spinee.2007.10.005.
PubMed 18164449Healy WL, Peterson RN. Department of Justice investigation of orthopaedic industry. J Bone Joint Surg Am. 2009 Jul;91(7):1791-805. doi: 10.2106/JBJS.I.00096. No abstract available.
PubMed 19571103Perret D, Rosen C. A physician-driven solution--the Association for Medical Ethics, the Physician Payment Sunshine Act, and ethical challenges in pain medicine. Pain Med. 2011 Sep;12(9):1361-75. doi: 10.1111/j.1526-4637.2011.01217.x.
PubMed 21914121Viola DC, Lenza M, Almeida SL, Santos OF, Cendoroglo Neto M, Lottenberg CL, Ferretti M. Spine surgery cost reduction at a specialized treatment center. Einstein (Sao Paulo). 2013 Jan-Mar;11(1):102-7. doi: 10.1590/s1679-45082013000100018.
PubMed 23579752Delitto A, Erhard RE, Bowling RW. A treatment-based classification approach to low back syndrome: identifying and staging patients for conservative treatment. Phys Ther. 1995 Jun;75(6):470-85; discussion 485-9. doi: 10.1093/ptj/75.6.470.
PubMed 7770494Fritz JM, Cleland JA, Childs JD. Subgrouping patients with low back pain: evolution of a classification approach to physical therapy. J Orthop Sports Phys Ther. 2007 Jun;37(6):290-302. doi: 10.2519/jospt.2007.2498.
PubMed 17612355van der Roer N, Ostelo RW, Bekkering GE, van Tulder MW, de Vet HC. Minimal clinically important change for pain intensity, functional status, and general health status in patients with nonspecific low back pain. Spine (Phila Pa 1976). 2006 Mar 1;31(5):578-82. doi: 10.1097/01.brs.0000201293.57439.47.
PubMed 16508555
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Opinion in Spinal Surgery Indications: Cost-Effectiveness Evaluation
- ClinicalTrials.gov ID
- NCT03082248
- Acronym / sponsor ID
- Low Back Pain
- Conditions
- Low Back Pain, Lumbar Spine Injury
- Keywords
- Low Back Pain, Surgery, Lumbar Spine, Physical Therapy Modalities, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 17 Mar 2017 (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.
Low back pain is a common symptom, which often affects the adult population. Studies show that over the past two decades, costs related to spinal surgery have increased significantly, leading to speculation about what would be motivating this phenomenon. Although expenses with physical therapy treatments and less invasive surgical procedures remained relatively stable, the amount spent with more complex spine surgeries increased exponentially until they became the procedures with the highest costs in healthcare. The criteria for surgical indication are not uniform among surgeons and therefore a study of second opinion in spine surgeries is urgently needed. The present study aims to 1) quantify cost-effectiveness of second opinion for patients with spinal surgery indication 2) evaluate effectiveness of conservative and surgical treatment for degenerative diseases of the lumbar spine 3) define objective criteria for indication of conservative and surgical treatment using evidence-based medicine 4) evaluate prognosis of biological markers in the follow-up of patients with lumbar affections 5) evaluate interobserver agreement of physicians in relation to the diagnoses and treatment proposals in patients with diseases of the lumbar spine 6) verify effectiveness of patients who were operated on, compared to patients who were not operated. A prospective cohort study will be conducted, in which patients with an indication of surgical spinal treatment will be evaluated for a second opinion. First evaluation diagnoses and indications for patient treatment will be compared with the second opinion evaluation. All patients who choose to participate on the study will be followed up for a year for evaluations concerning cost-effectiveness, pain, quality of life, function and blood biomarkers. The outcomes will be compared using linear or generalized mixed models and descriptive analyzes of the study population program will be carried out; Statistical agreement will be observed between the first and second opinion and also patient acceptance rates for the treatment proposed in the second indication, evaluating the validity of the project approach. A five-year budget impact analysis will also be carried out, taking into account the population who was eligible for treatment according to the admission flow of a private outpatient setting.
Detailed description
The present study could provide benefits to all aspects of treatment approaches involved in patients with low back pain: for the entire medical community by presenting better information about the actual surgical indications for patients with low back pain; for health insurers and in general, who can spend their investments in really effective areas, and especially for patients, who will receive appropriate treatments for their conditions.
190 patients with indication of surgical treatment will be enrolled for this clinical trial and will be advised to receive a second opinion at Hospital Israelite Albert Einstein (HIAE).
Both assessments (with orthopedic physicians) will be compared, and when consensus is reached about diagnostic hypotheses and treatment, patients will be referred for conservative or surgical treatment. Any disagreements will be resolved by a committee of spine surgeons (four orthopedists and four neurosurgeons with more than 15 years of experience).
When the treatment chosen for the first medical care (two consultations of the orthopedic surgeons) is the conservative treatment, patients will be referred to consultations in the rehabilitation center. When surgical treatment is indicated, the patient will be referred to one of the eight surgeons of the spinal committee.
All patients will have the freedom of choice to decide to participate in the study guided by the second opinion service or perform the recommended treatment in the first hospital in which they were treated.
Sample size: For the calculation of the sample size estimate, we considered data presented in the study by van der Roer et al. (2006), in which the mean score obtained by the EuroQol instrument in pre-treatment patients was 0.70 in chronic patients, with standard deviation of 0.19. Assuming that the correlation between the measurements obtained at the two main moments of comparison (baseline and after 10 weeks of treatment) is of the order of 0.5 and that the minimally relevant difference between the two moments is 0.07, we estimate that 90 patients should be considered in the conservative treatment group. Assuming that of the patients who use the second opinion service about 55% will perform surgical procedures in the service, we estimate that 100 patients should be included in this group. Sample size estimates were performed with the statistical package STATA version 10.0, considering 90% power and 5% level of significance.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy Group | Other | Other: Physical Therapy10-week supervised physiotherapeutic intervention; all patients will receive educational leaflets and folders for maintenance and adherence to the treatment program. |
| Spinal Surgery Group | Other | Procedure: Spinal SurgerySurgical procedures and techniques specific for the low back region, previously discussed and agreed upon among surgeons according to patients description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with surgery indication (referred by the health care provider) for the treatment of degenerative diseases of the lumbar spine (basically: intervertebral disc disease, degenerative spondylolisthesis, lumbar canal stenosis, facet low back pain and lumbar instability);
- no contraindication to general anesthesia or any physiotherapeutic procedure;
- able to understand Portuguese language and after acceptance of a written consent.
Key exclusion criteria (8 listed)
- Patients with:
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 |
|---|---|---|
| Physical TherapyPatients allocated to the conservative treatment group will receive physical therapy according to the treatment-based classification approach and also educational leaflets and folders. | Other | Physical Therapy Group |
| Spinal SurgeryPatients allocated to the surgical procedure group will undergo spinal surgery procedures and techniques specific for the low back region. | Procedure or surgery | Spinal Surgery Group |
Primary outcome
Cost Effectiveness analysis
Time frame: 12 months after treatment
EuroQoL will be combined with a Visual Analogue Scale(VAS) to carry out the cost-effectiveness analysis of the second opinion program.
6 secondary outcomes
Change in Pain Intensity
Time frame: 1, 3, 6 and 12 months after treatment
Change in Disability
Time frame: 1, 3, 6 and 12 months after treatment
Change in Global Impression of Recovery
Time frame: 1, 3, 6 and 12 months after treatment
Change in Kinesiophobia
Time frame: 1, 3, 6 and 12 months after treatment
Change in Psychosocial Risk Prognosis
Time frame: 1, 3, 6 and 12 months after treatment
Change in Mood Disorders in The setting of Medical Practice
Time frame: 1, 3, 6 and 12 months after treatment
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 22 Sep 2023.
- Background: PubMed 18270354Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, Sullivan SD. Expenditures and health status among adults with back and neck problems. JAMA. 2008 Feb 13;299(6):656-64. doi: 10.1001/jama.299.6.656.
- Background: PubMed 18164449Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008 Jan-Feb;8(1):8-20. doi: 10.1016/j.spinee.2007.10.005.
- Background: PubMed 19571103Healy WL, Peterson RN. Department of Justice investigation of orthopaedic industry. J Bone Joint Surg Am. 2009 Jul;91(7):1791-805. doi: 10.2106/JBJS.I.00096. No abstract available.
- Background: PubMed 21914121Perret D, Rosen C. A physician-driven solution--the Association for Medical Ethics, the Physician Payment Sunshine Act, and ethical challenges in pain medicine. Pain Med. 2011 Sep;12(9):1361-75. doi: 10.1111/j.1526-4637.2011.01217.x.
- Background: PubMed 23579752Viola DC, Lenza M, Almeida SL, Santos OF, Cendoroglo Neto M, Lottenberg CL, Ferretti M. Spine surgery cost reduction at a specialized treatment center. Einstein (Sao Paulo). 2013 Jan-Mar;11(1):102-7. doi: 10.1590/s1679-45082013000100018.
- Background: PubMed 7770494Delitto A, Erhard RE, Bowling RW. A treatment-based classification approach to low back syndrome: identifying and staging patients for conservative treatment. Phys Ther. 1995 Jun;75(6):470-85; discussion 485-9. doi: 10.1093/ptj/75.6.470.
- Background: PubMed 17612355Fritz JM, Cleland JA, Childs JD. Subgrouping patients with low back pain: evolution of a classification approach to physical therapy. J Orthop Sports Phys Ther. 2007 Jun;37(6):290-302. doi: 10.2519/jospt.2007.2498.
- Background: PubMed 16508555van der Roer N, Ostelo RW, Bekkering GE, van Tulder MW, de Vet HC. Minimal clinically important change for pain intensity, functional status, and general health status in patients with nonspecific low back pain. Spine (Phila Pa 1976). 2006 Mar 1;31(5):578-82. doi: 10.1097/01.brs.0000201293.57439.47.
- Individual participant dataSharing planned: Undecided. We are happy to share our data with researchers that would like to use it on an individual participant data
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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.
Mario Ferretti, MD, PhD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy and Spinal Surgery in people with Low Back Pain and Lumbar Spine Injury, 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 3 inclusion and 8 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 22 Sep 2023. 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?
Cost Effectiveness analysis (time frame: 12 months after treatment). 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 NCT03082248, which also lists 8 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 22 Sep 2023.