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Second Opinion in Spinal Surgery Indications: Cost-Effectiveness Evaluation

Primary Purpose

Low Back Pain, Lumbar Spine Injury

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical Therapy
Spinal Surgery
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Back Pain focused on measuring Low Back Pain, Surgery, Lumbar Spine, Physical Therapy Modalities, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Israelita Albert Einstein

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Physical Therapy Group

Spinal Surgery Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Pain Intensity
Pain intensity will be measured using VAS 0-10 (0 being no pain and 10 maximum pain)
Change in Disability
Disability will be measured by the Oswestry Disability Index, Brazilian version 2.0.
Change in Global Impression of Recovery
Global impression of recovery will be measured by the Global Perceived Effect of Change(GPE)
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)
Change in Psychosocial Risk Prognosis
Psychosocial risk prognosis will be measured by the brazilian version of the STarT Back screening tool
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)

Full Information

First Posted
March 3, 2017
Last Updated
September 21, 2023
Sponsor
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT03082248
Brief Title
Second Opinion in Spinal Surgery Indications: Cost-Effectiveness Evaluation
Official Title
Second Opinion in Spinal Surgery Indications: Cost-Effectiveness Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Lumbar Spine Injury
Keywords
Low Back Pain, Surgery, Lumbar Spine, Physical Therapy Modalities, Rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy Group
Arm Type
Other
Arm Description
10-week supervised physiotherapeutic intervention; all patients will receive educational leaflets and folders for maintenance and adherence to the treatment program.
Arm Title
Spinal Surgery Group
Arm Type
Other
Arm Description
Surgical procedures and techniques specific for the low back region, previously discussed and agreed upon among surgeons according to patients description.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
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
Procedure
Intervention Name(s)
Spinal Surgery
Intervention Description
Patients allocated to the surgical procedure group will undergo spinal surgery procedures and techniques specific for the low back region.
Primary Outcome Measure Information:
Title
Cost Effectiveness analysis
Description
EuroQoL will be combined with a Visual Analogue Scale(VAS) to carry out the cost-effectiveness analysis of the second opinion program.
Time Frame
12 months after treatment
Secondary Outcome Measure Information:
Title
Change in Pain Intensity
Description
Pain intensity will be measured using VAS 0-10 (0 being no pain and 10 maximum pain)
Time Frame
1, 3, 6 and 12 months after treatment
Title
Change in Disability
Description
Disability will be measured by the Oswestry Disability Index, Brazilian version 2.0.
Time Frame
1, 3, 6 and 12 months after treatment
Title
Change in Global Impression of Recovery
Description
Global impression of recovery will be measured by the Global Perceived Effect of Change(GPE)
Time Frame
1, 3, 6 and 12 months after treatment
Title
Change in Kinesiophobia
Description
Assessment of fear avoidance beliefs related to physical activity and work will be evaluated by the questionnaire Fear avoidance Beliefs Questionnaire (FABQ)
Time Frame
1, 3, 6 and 12 months after treatment
Title
Change in Psychosocial Risk Prognosis
Description
Psychosocial risk prognosis will be measured by the brazilian version of the STarT Back screening tool
Time Frame
1, 3, 6 and 12 months after treatment
Title
Change in Mood Disorders in The setting of Medical Practice
Description
Anxiety and depression aspects will be measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame
1, 3, 6 and 12 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Ferretti, MD, PhD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05652-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We are happy to share our data with researchers that would like to use it on an individual participant data
Citations:
PubMed Identifier
18270354
Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
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PubMed Identifier
21914121
Citation
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Results Reference
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PubMed Identifier
23579752
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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. Erratum In: J Orthop Sports Phys Ther. 2007 Dec;37(12):769.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Second Opinion in Spinal Surgery Indications: Cost-Effectiveness Evaluation

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