Identification of Patients at Risk of Chronic Back Pain Using Questionnaires

NCT02600663 | Terminated DMC

• 1 other identifier: 2015-10
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (2)

• risk of chronic back pain determined by Heidelberger short questionnaire score

  at enrolment

• risk of chronic back pain determined by Keele questionnaire

  at enrolment

Secondary Outcomes (5)

• numeric rating scale average pain intensity

  at enrolment, at 6 months

• numeric rating scale minimal pain intensity

  at enrolment, at 6 months

• numeric rating scale pain related sleep-loss

  at enrolment, at 6 months

• clothepin-algometry (numeric rating scale)

  at enrolment

• working days missed

  at enrolment, at 6 months

Study Arms (1)

acute back pain

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients with acute back pain presenting at the general pratcioner

You may qualify if:

• acute (\<6 weeks) back pain
• \>20 und \<60 years of age
• good oral and written knowledge of German language

You may not qualify if:

• any treatment for back pain within the last 6 months
• Cauda equina
• tumor
• generalized pain
• severe systemic illness
• substance abuse
• pregnancy

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 9, 2015
• Study Start: April 1, 2016
• Primary Completion: October 14, 2019
• Study Completion: October 14, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)