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

Sponsor
Sano (Other)
Overall Status
Completed
CT.gov ID
NCT02892656
Collaborator
(none)
152
2
30.6
76
2.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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).

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    152 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Reliability and Responsiveness of the Danish Version of the Pain Self-Efficacy Questionnaire in Patients With Chronic Low Back Pain
    Actual Study Start Date :
    Aug 10, 2017
    Actual Primary Completion Date :
    Feb 28, 2020
    Actual Study Completion Date :
    Feb 28, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Pain Self-efficacy questionnaire [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sano Middelfart Denmark 5500
    2 Sano Skælskør Denmark 4230

    Sponsors and Collaborators

    • Sano

    Investigators

    • Principal Investigator: Anne Mette Schmidt, Msc. H.S., Sano

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sano
    ClinicalTrials.gov Identifier:
    NCT02892656
    Other Study ID Numbers:
    • Sano 2
    First Posted:
    Sep 8, 2016
    Last Update Posted:
    Aug 17, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 17, 2020