NCT02402335

Brief Summary

The purpose of this study is to examine whether there are relations between different types of pain in groups of patients with different diagnoses of degenerative diseases of the spinal column and their related surgeries.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

March 18, 2015

Last Update Submit

March 24, 2015

Conditions

Ache

Outcome Measures

Primary Outcomes (1)

  • Backache objectified by the PainDETECT Questionnaire

    6 months

Study Arms (2)

1 Fracture of vertebra

Osteoporotic fracture of the vertebra

2 Nerve Compression

Osteochondria, Spinal disc herniation, Nerve compression

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of the University Hospital of Bonn who are strongly suffering from backaches that cannot be treated anymore by conservative methods.

You may qualify if:

  • Backache because of degenerative diseases
  • Surgery is necessary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Pflugmacher, PD Dr med

    University Hospital Bonn, Clinics of Orthopedics and Traumatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Pflugmacher, PD Dr med

CONTACT

robert.pflugmacher@ukb.uni-bonn.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr med Robert Pflugmacher

Study Record Dates

First Submitted

March 18, 2015

First Posted

March 30, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2016

Study Completion

January 1, 2017

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

DE(1)