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

Ache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02402335
• Other study ID #: UKBORTAB01
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2015
• Last updated: March 24, 2015
• Start date: February 2015
• Est. completion date: January 2017

Study information

• Verified date: March 2015
• Source: University Hospital, Bonn
• Contact: Robert Pflugmacher, PD Dr med
• Email: robert.pflugmacher[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Backache because of degenerative diseases

• Surgery is necessary

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ache

Locations

Country	Name	City	State
Germany	University Hospital of Bonn	Bonn	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Backache objectified by the PainDETECT Questionnaire		6 months	No