Assessment of Central Pain in Patients Who Undergo Spinal Surgery and Influence in Surgery Outcome

NCT01299818 | Unknown DMC

• 1 other identifier: 0104-10-TLV
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Surgery; Pain

Keywords

central pain; spine surgey; outcome; patients undergo spinal surgery

Outcome Measures

Primary Outcomes (1)

• evaluation of surgery outcome including pain and functionnal ability

  evaluation of course of surgery, use of analgesics medications, report of pain intensity, length of hospital stay, questionnaires of health status and functionnal index, physical examination and dolorimetric evaluation

  3 months

Study Arms (1)

spinal surgery

patients who undergo spinal surgery

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (1)

• 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.

  PMID: 19647139 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacob Ablin, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

valerie Aloush, MD

CONTACT

+972524266914; valerie.aloush@gmail.com

Jacob Ablin, MD

CONTACT

+972524266774; jacobab@tasmc.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 18, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 18, 2011

Record last verified: 2011-02

Locations

IL (1)