Second Opinion in Spinal Surgery Indications: Cost-Effectiveness Evaluation

NCT03082248 | Completed

• 1 other identifier: Low Back Pain
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Lumbar Spine Injury

Keywords

Low Back Pain; Surgery; Lumbar Spine; Physical Therapy Modalities; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after treatment

Secondary Outcomes (6)

• Change in Pain Intensity

  1, 3, 6 and 12 months after treatment

• Change in Disability

  1, 3, 6 and 12 months after treatment

• Change in Global Impression of Recovery

  1, 3, 6 and 12 months after treatment

• Change in Kinesiophobia

  1, 3, 6 and 12 months after treatment

• Change in Psychosocial Risk Prognosis

  1, 3, 6 and 12 months after treatment

Study Arms (2)

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.

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.

Procedure: Spinal Surgery

Interventions

Physical Therapy 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.

Physical Therapy Group

Spinal Surgery PROCEDURE

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

Spinal Surgery Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-000, Brazil

Location

Related Publications (8)

• 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.

  PMID: 18270354 BACKGROUND

• 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.

  PMID: 18164449 BACKGROUND

• 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.

  PMID: 19571103 BACKGROUND

• 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.

  PMID: 21914121 BACKGROUND

• 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.

  PMID: 23579752 BACKGROUND

• 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.

  PMID: 7770494 BACKGROUND

• 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.

  PMID: 17612355 BACKGROUND

• 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.

  PMID: 16508555 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Spinal Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Mario Ferretti, MD, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 17, 2017
• Study Start: September 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2019
• Last Updated: September 22, 2023

Record last verified: 2018-07

Locations

BR (1)