Qualitative Pain Measurement at Patients With Degenerative Low Back Pain

NCT01980576 | Terminated

• 1 other identifier: N-20110053
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degeneration of Lumbar Intervertebral Disc

Keywords

Pain; Sensitization; Spondylitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pre-operative pain measurement

Patients with low back pain

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic.

You may qualify if:

• 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

You may not qualify if:

• removal of implants
• diabetic neuropathy or another neuropathic disease
• neurological diseases
• unability to read or understand Danish

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, Region of Northern Jutland, 9000, Denmark

Location

MeSH Terms

Conditions

Pain; Spondylitis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Study Officials

• Sten Rasmussen, M.D.

  Aalborg University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 11, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

DK (1)