Qualitative Pain Measurement at Patients With Degenerativ... | NCT01980576

Studies
Qualitative Pain Measurement at Patients With Degenerative Low Back Pain

NCT01980576

Sponsor

Northern Orthopaedic Division, Denmark

Status

Terminated

Last Update Posted

Apr 10, 2015Estimated

Enrollment

1Actual

Phase

Not provided

Conditions

Degeneration of Lumbar Intervertebral Disc

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of patients with the right criteria for inclusion

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Oct 28, 2013

First Submission Date that Met QC Criteria

Nov 4, 2013

First Posted Date

Nov 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2015

Last Update Posted Date

Apr 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
Pre-operative pain measurement		Patients with low back pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sten Rasmussen, M.D.	Aalborg University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg University Hospital		Aalborg	Region of Northern Jutland	9000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D013166	Spondylitis

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001850	Bone Diseases, Infectious

Browse Leaves

Not provided

Browse Branches

Not provided