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Completed

NCT Number: NCT02892656

Reliability and Responsiveness of One Questionnaire Used on a Low Back Pain Population

The purpose of this study is to determine the reliability and responsiveness of the Pain Self-Efficacy Questionnaire (PSEQ) in a chronic low back pain (CLBP) population referred to The Danish Rheumatism Associations´ rehabilitation centre Sano Aarhus.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sano, Middelfart, Denmark

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About this study

Chronic low back pain (CLBP) is a highly prevalent health condition, and the leading cause of years lived with disability both globally and in Denmark. In the majority of patients with CLBP, no underlying pathology or cause can be identified and CLBP is acknowledged to be multifactorial. CLBP is defined by symptoms lasting for a period longer than three months. The high prevalence of CLBP causes a substantial impact on patients and their families, communities and health-care systems, as well as a financial burden. Besides pain and disability people with CLBP often experience psychosocial consequences with signs of anxiety and depression and effects on social, leisure, and work life.

An important component in rehabilitation is documentation of treatment outcomes. This demands that a change over time can be measured. To determine effect, the measurement tool must detect real or important change over time. This requires the measurement tool is reliable, and therefore will show no real or important change in periods where the patient is stable. If the measurement tool shows real or important change, in periods where there is no change in the patient state, the results can not be predicted as an effect from an intervention, but due to uncertainty of measurement tool.

The measurement tool is selected by the recommendation of literature and involvement of clinicians and patients at sano, and examines patient with CLBP.

It is found necessary to determine the reliability and responsiveness of the PSEQ on the CLBP population referred to Sano Aarhus. Data will be electronically entered in, stored in and collected from Sanos internal database (SanoBasen).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • referred to The Danish Rheumatism Associations' rehabilitation centre Sano

Exclusion criteria

  • a rated physical status of > 3 according to the American Society of Anesthesiologists Physical Status Classification System
  • axial spondyloarthritis
  • spinal fracture within the last 3 months
  • severe osteoporosis
  • active cancer
  • active psychiatric pathology assessed by general practitioner before referral
  • pregnancy
  • low Danish language skills
  • no e-mail address

Treatment and study plan

Primary outcomes

  1. Pain Self-efficacy questionnaire

    Time frame: 12 months

    The PSEQ consists of 10 items, each item is scored on a seven-point Likert scale with responses ranging from 0 (not at all confident) to 6 (completely confident). A total score is calculated by summing the scores of the 10 items yielding a total sum score ranging from 0-60. Higher scores indicate a stronger self-efficacy belief

Sponsors and collaborators

Lead sponsor

Sano

Other

Registry information

Official study title

Reliability and Responsiveness of the Danish Version of the Pain Self-Efficacy Questionnaire in Patients With Chronic Low Back Pain

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 8, 2016
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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