Identification of Patients at Risk of Chronic Back Pain Using Questionnaires

Back Pain Clinical Trial

— chron_pain  

Official title:

Identification of Patients at Risk of Chronic Back Pain Using Questionnaires

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02600663
• Other study ID #: 2015-10
• Status: Terminated
• Start date: April 1, 2016
• Est. completion date: October 14, 2019

Study information

• Verified date: December 2019
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with acute back pain (<6 weeks) presenting at their general practitioner will be enrolled. Patients fulfilling all inclusion criteria and showing no exclusion criteria will fill out the Heidelberg short questionnaire (HKF-R10) and the Keele STarT Back Screening Tool. These two questionnaires categorize back pain patients into individuals at risk of chronic back pain and those not at risk. Furthermore, data concerning pain location, severity, duration and impairment will be collected. Study participants will receive standard care treatment prescribed by their general practitioner. Six months later, study participants will receive a questionnaire in order to collect data concerning their present pain situation. Patients with relevant impairment in their activities of daily living as a result of back pain will be categorized as individuals with chronic back pain. Categorization at six months will be compared with the categorization at presentation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 14, 2019
• Est. primary completion date: October 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• acute (<6 weeks) back pain

• >20 und <60 years of age

• good oral and written knowledge of German language

Exclusion Criteria:

• any treatment for back pain within the last 6 months

• Cauda equina

• tumor

• generalized pain

• severe systemic illness

• substance abuse

• pregnancy

Related Conditions & MeSH terms

• Back Pain

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	risk of chronic back pain determined by Heidelberger short questionnaire score		at enrolment
Primary	risk of chronic back pain determined by Keele questionnaire		at enrolment
Secondary	numeric rating scale average pain intensity		at enrolment, at 6 months
Secondary	numeric rating scale minimal pain intensity		at enrolment, at 6 months
Secondary	numeric rating scale pain related sleep-loss		at enrolment, at 6 months
Secondary	clothepin-algometry (numeric rating scale)		at enrolment
Secondary	working days missed		at enrolment, at 6 months