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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01299818
First received: February 17, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose
  • 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
Spinal Surgery
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Central Pain in Patients Who Undergo Spinal Surgery and Influence in Surgery Outcome

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • evaluation of surgery outcome including pain and functionnal ability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
spinal surgery
patients who undergo spinal surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299818

Contacts
Contact: valerie Aloush, MD +972524266914 valerie.aloush@gmail.com
Contact: Jacob Ablin, MD +972524266774 jacobab@tasmc.health.gov.il

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

Publications:
Responsible Party: Jacob Ablin, TASMC
ClinicalTrials.gov Identifier: NCT01299818     History of Changes
Other Study ID Numbers: 0104-10-TLV
Study First Received: February 17, 2011
Last Updated: February 17, 2011
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

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

ClinicalTrials.gov processed this record on October 21, 2014