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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01299818
• Other study ID #: 0104-10-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: February 17, 2011
• Last updated: February 17, 2011
• Start date: March 2011
• Est. completion date: April 2012

Study information

• Verified date: February 2011
• Source: Tel-Aviv Sourasky Medical Center
• Contact: valerie Aloush, MD
• Phone: +972524266914
• Email: valerie.aloush[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain
• Spinal Surgery

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No