Second opinion on spine surgeries: an option or necessity?
- Conditions
- Symptoms related to diseases that affect the spineSigns and Symptoms
- Registration Number
- ISRCTN07143259
- Lead Sponsor
- Hospita Israelita Albert Einstein (Brazil)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 560
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
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method