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Second opinion on spine surgeries: an option or necessity?

Second opinion on spine surgeries: an option or necessity?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN07143259
Enrollment
560
Registered
2013-02-25
Start date
2011-05-01
Completion date
Unknown
Last updated
2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptoms related to diseases that affect the spine Signs and Symptoms

Interventions

Allocation All patients covered by an insurance health company who received a surgical indication for their spine problems and who were included in the above criteria were referred to receive a second
the first consultation was with a physiatrist and the second one was with a general orthopaedic surgeon. All appointments began with a thorough anammnesis, neurological and orthopaedic physical examin
when necessary, new or different subsidiary exams were requested. Both appointments (by physiatrists and orthopaedics) were compared
achieving concordance between the diagnostic hypotheses and proposed of treatment, the patients were referred to two different paths of treatment: non-operative interventions or surgical treatment. An
when surgical treatment was option, the patient was referred to one of nine and senior spine surgeons (orthopaedic or neurosurgeon) having more than 15 years of spinal surgery experience. Conservativ

Sponsors

Hospita Israelita Albert Einstein (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Recruitment of patients took place in a private hospital in order to give a second opinion of all patients who were referred to spinal (cervical and lumbar) surgical intervention from other hospitals. To be eligible, participants had to meet the following criteria: 1. Adults aged 18 years or older with any indication of spinal surgery due to lumbar or cervical stenosis, lumbar or cervical disc herniation, and other causes of chronic back pain including the annulus fibrosus of the disc, spinal ligaments, spinal nerves, dorsal root ganglia, zygapophyseal joint, sacroiliac joint, and paraspinal muscles 2. No medical contraindication to general anaesthesia 3. Understanding of Portuguese language and written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with spinal fractures 2. Scoliosis 3. Congenital spinal deformity 4. Spinal tumours 5. Inability to comply with follow-up (a transient or an inability to read or complete forms).

Design outcomes

Primary

MeasureTime frame
Overall neck and low back pain, measured on a visual analogical scale (VAS) of 0 to 10 (with 0 indicating no pain, 10 indicating the maximum pain) (Grotle 2004; Huskisson 1982)

Secondary

MeasureTime frame
1. Health-related quality of life, measured by the Short Form-36 (Ware 1992) 2. Function or disability endpoints for low back pain, measured by: 2.1. The Roland? Morris Disability Questionnaire (Roland 1983; Roland 2000) validated and translated into Portuguese (Nusbaum 2001), in which scores range from 0 to 24, with higher numbers indicating worse physical functioning 2.2. Oswestry Disability Index (Fairbank 1980; Baker 1989; Roland 2000) the 2.0 version cross-culturally adapted to Brazilian Portuguese (Vigatto 2007); it includes 10 six-point scales, the sum of the 10 scores is expressed as a percentage of the maximum scores; the total of points ranges from 0 (no disability) to 100 (maximum disability). 3. Adverse events (complications) related with the conservative and the surgical treatments, assessed at each time point with the use of open-ended questions Baseline data, which were collected by nurses not directly involved in the study, included sex, age, height, weight, smoking status and alcohol use, medication use and primary indication to surgery prior to the second opinion. At baseline, each participant also was invited to fill quality of life and functional/disability questionnaires. All participants were evaluated by telephone questionnaires at 1, 3, 6 and 12 months after the treatment.

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026