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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01299818
Recruitment Status : Unknown
Verified February 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 18, 2011
Last Update Posted : February 18, 2011
Information provided by:
Tel-Aviv Sourasky Medical Center

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

Condition or disease
Spinal Surgery Pain

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Central Pain in Patients Who Undergo Spinal Surgery and Influence in Surgery Outcome
Study Start Date : March 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

spinal surgery
patients who undergo spinal surgery

Primary Outcome Measures :
  1. evaluation of surgery outcome including pain and functionnal ability [ Time Frame: 3 months ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01299818

Contact: valerie Aloush, MD +972524266914
Contact: Jacob Ablin, MD +972524266774

Tel Aviv Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Jacob Ablin, MD Tel-Aviv Sourasky Medical Center

Responsible Party: Jacob Ablin, TASMC Identifier: NCT01299818     History of Changes
Other Study ID Numbers: 0104-10-TLV
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: February 2011

Keywords provided by Tel-Aviv Sourasky Medical Center:
central pain
spine surgey
patients undergo spinal surgery