Clinical trial NCT01299818: Assessment of Central Pain in Patients Who Undergo Spinal Surgery and Influence in Surgery Outcome
Official title: Assessment of Central Pain in Patients Who Undergo Spinal Surgery and Influence in Surgery Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Surgery
Pain
Keywords: central pain
spine surgey
outcome
patients undergo spinal surgery
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients sufferring of cervicalgia and/or low back pain and/or radiculopathy that are candidates to spinal surgery

Brief summary: * Pain is one of the most common concerns for which patients seek medical attention.
* Pain is usually understood as symptom that reflects peripheral organic damage. Many patients experience pain, often chronically, independently of any underlying cause such as chronic regional pain syndromes (irritable bowel syndrome, temporo-mandibular pain syndrome, chronic headache or chronic low back pain)or diffuse like in fibromyalgia. In all those "functional" syndromes, accumulated evidence supports involvement of central pain processing systems, hypothalamic pituitary adrenal axes and autonomic nervous system, and are now referred as central pain conditions.
* Other patients suffers from chronic pain caused by damage or inflammation in peripheral tissues, but also experienced more diffuse pain, not directly explained by peripheral damage, that further aggravates pain and function. This is illustrated by the high prevalence of fibromyalgia observed in patients with rheumatoid arthritis, osteoarthritis or ankylosing spondylitis for example.

These pain conditions are now understood as combinations of peripheral, neuropathic and central pain.

The investigators aimed to focus in this study in patients that are candidates to spinal surgery and suffer from low back pain and/or radiculopathy. Pain in these patients may arise from damage to nerves - neuropathic pain- , to musculoskeletal structures - peripheral pain-, and may also reflects alteration in central pain processes.

In these patients, spine surgery is usually performed to improve quality of life, decrease pain and avoid neurological deficits. Evaluation of surgical outcome includes objective measures such as neurological findings and radiographic evaluation, and subjective measures including patient self-assessments for pain and quality of life and psychological changes.

The aim of this study is to evaluate patients who undergo spinal surgery for presence of central pain and central sensitization symptoms and evaluate their influence on these surgical outcomes


Eligibility criteria: Inclusion Criteria:

* candidates to spinal surgery attending the spine clinic
* able to give inform consent

Exclusion Criteria:

* pregnant women
* children under 18
* current infection in spine

Primary outcomes:
measure: evaluation of surgery outcome including pain and functionnal ability
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Jacob Ablin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ablin K, Clauw DJ. From fibrositis to functional somatic syndromes to a bell-shaped curve of pain and sensory sensitivity: evolution of a clinical construct. Rheum Dis Clin North Am. 2009 May;35(2):233-51. doi: 10.1016/j.rdc.2009.06.006.