Second Opinion in Spinal Surgery Indications: Cost-Effectiveness Evaluation

NCT ID: NCT03082248

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-12-30

Brief 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. 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.

Conditions

Low Back Pain; Lumbar Spine Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Physical Therapy Group

10-week supervised physiotherapeutic intervention; all patients will receive educational leaflets and folders for maintenance and adherence to the treatment program.

Group Type: OTHER

Physical Therapy

Intervention Type: OTHER

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 Surgery Group

Surgical procedures and techniques specific for the low back region, previously discussed and agreed upon among surgeons according to patients description.

Group Type: OTHER

Spinal Surgery

Intervention Type: PROCEDURE

Patients allocated to the surgical procedure group will undergo spinal surgery procedures and techniques specific for the low back region.

Interventions

Physical Therapy

Patients allocated to the conservative treatment group will receive physical therapy according to the treatment-based classification approach and also educational leaflets and folders.

Intervention Type: OTHER

Spinal Surgery

Patients allocated to the surgical procedure group will undergo spinal surgery procedures and techniques specific for the low back region.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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);

2. no contraindication to general anesthesia or any physiotherapeutic procedure;

3. able to understand Portuguese language and after acceptance of a written consent.

Exclusion Criteria

• Patients with:

1. spinal fractures;

2. scoliosis greater than 20 degrees;

3. congenital deformities;

4. spinal tumors;

5. confirmed or suspected pregnancy;

6. history of previous surgery in the spine; and,

7. unable to participate in the follow-up (due to inability to read or complete the required forms).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mario Ferretti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 18270354 (View on PubMed)

Dagenais 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.

Reference Type: BACKGROUND

PMID: 18164449 (View on PubMed)

Healy 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.

Reference Type: BACKGROUND

PMID: 19571103 (View on PubMed)

Perret 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.

Reference Type: BACKGROUND

PMID: 21914121 (View on PubMed)

Viola 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.

Reference Type: BACKGROUND

PMID: 23579752 (View on PubMed)

Delitto 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.

Reference Type: BACKGROUND

PMID: 7770494 (View on PubMed)

Fritz 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.

Reference Type: BACKGROUND

PMID: 17612355 (View on PubMed)

van 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.

Reference Type: BACKGROUND

PMID: 16508555 (View on PubMed)

Other Identifiers

Low Back Pain

Identifier Type: -

Identifier Source: org_study_id