Qualitative Pain Measurement at Patients With Degenerative Low Back Pain

Degeneration of Lumbar Intervertebral Disc Clinical Trial

Official title:

Qualitative Pain Measurement and Sensitization at Patients With Degenerative Low Back Pain With Indication for Lumbar Intervertebral Disc

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01980576
• Other study ID #: N-20110053
• Status: Terminated
• Phase: N/A
• First received: October 28, 2013
• Last updated: April 9, 2015
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

The purpose of the study is:

• to measure sensitization of the nociceptive system at patients with low back pain in order to carry out a necessary surgical procedure

• to examine a possible association between low back pain and degenerative changes

• to analyse if low back pain is related to the clinical result 6 months after surgery

• to set up a model for pre-operative measurement of pain.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients who are going to be treated surgically for spondylitis

• ability to understand Danish in order to filling in a questionnaire

• a written signed statement of consent

Exclusion Criteria:

• removal of implants

• diabetic neuropathy or another neuropathic disease

• neurological diseases

• unability to read or understand Danish

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Degeneration of Lumbar Intervertebral Disc
• Intervertebral Disc Degeneration
• Low Back Pain

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	Region of Northern Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measured at lumbar area, hip and ankle by an algometer	On basis of the extended examinations of low back pain, we expect to achieve a better knowledge to measure pain at this category of patients before a possible surgical procedure.	6 months	Yes