Study of Different Types of Backache in Groups of Patients With Different Diagnoses of Degenerative Diseases

March 24, 2015 updated by: Robert Pflugmacher, University Hospital, Bonn

Study of Different Types of Pains in Groups of Patients With Different Diagnoses of Degenerative Diseases and Their Related Surgeries

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

In the context of this work the pain of different groups of patients should be examined by means of the painDetect Questionnaire, the Roland-Morris disability questionnaire, clinical examinations and different imaging procedures. Two groups of patients are compared with each other. Group one consists of patients with osteoporotic fractures of the vertebra. Group two is formed by patients with osteochondria , spinal disc herniation and nerval compression. Both groups of patients undergo surgery, as they are suffering from pain (e.g. kyphoplasty, nucleotomy, spondylodesis, decompression). In order to differentiate between chronic nociceptive pain and chronic neuropathic pain in these two groups the painDetect questionnaire is used. To examine the severity of disability in the patients' everyday life the Roland-Morris Disability questionnaire is used.

The included patients are examined and seen preoperative, postoperative before discharge from hospital, 6 weeks and 6 months after surgery.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • Backache because of degenerative diseases
  • Surgery is necessary

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1 Fracture of vertebra
Osteoporotic fracture of the vertebra
2 Nerve Compression
Osteochondria, Spinal disc herniation, Nerve compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Backache objectified by the PainDETECT Questionnaire
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert Pflugmacher, PD Dr med, University Hospital Bonn, Clinics of Orthopedics and Traumatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • UKBORTAB01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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