NCT02892656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

2.6 years

First QC Date

September 2, 2016

Last Update Submit

August 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Self-efficacy questionnaire

    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

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic low back pain (defined as pain lasting for more than 12 months) with or without sciatica and/or with or without generalized pain identified by ICD-10 codes.

You may qualify if:

  • referred to The Danish Rheumatism Associations' rehabilitation centre Sano

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sano

Middelfart, 5500, Denmark

Location

Sano

Skælskør, 4230, Denmark

Location

Related Publications (1)

  • Vejlgaard C, Maribo T, Riisgaard Laursen J, Schmidt AM. Reliability and smallest detectable change of the Danish version of the Pain Self-Efficacy Questionnaire in patients with chronic low back pain. Scand J Pain. 2021 Jun 2;21(4):809-813. doi: 10.1515/sjpain-2021-0014. Print 2021 Oct 26.

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anne Mette Schmidt, Msc. H.S.

    Sano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 8, 2016

Study Start

August 10, 2017

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

August 17, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations