NCT03449004

Brief Summary

Low Back Pain (LBP) is the most common musculoskeletal disorder and a leading cause of disability worldwide. It is the most frequent reason for consulting general practice and has an impact on daily life and work capacity. A cornerstone in treating LBP is the provision of information to patients, and the internet is increasingly being used as a source of health information delivery. However, the effect of and satisfaction with online information have been questioned. The investigators aimed to develop and validate a multi-item instrument to measure an index score of satisfaction of online information for patients with LBP. The conceptualization of a Patient Reported Outcome (PRO) to measure a multidimensional index score is modelled on the assumption of a causal relationship between domains of experiences with online information and patients' combined index score of satisfaction. Findings from 15 patient interviews was applied to draft the first version of the instrument. Followed by pilot testing on patients (n=20) and experts (n=7) before validating the instrument on patients (n=150). Patients were eligible for inclusion if they had their first onset of LBP for 14 days. Patients were included regardless of pain intensity. Patients were excluded if they did not have Internet access, were pregnant, did not speak Danish as their native language, or had signs of serious underlying disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

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

February 14, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

March 19, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

February 14, 2018

Last Update Submit

May 29, 2019

Conditions

Keywords

Validationquestionnairesatisfactiononline information

Outcome Measures

Primary Outcomes (1)

  • Association between the Online Patient Satisfaction Index (0-24 Points, higher scores indicate higher satisfaction) and the Net Promotor Score (10-0 Points, 10-9 Points is categorised as promotors and 8-0 Points is categorised as non-promotors)

    Convergent validity

    Cross sectional (< 45 seconds)

Secondary Outcomes (3)

  • Association between the Online Patient Satisfaction Index (0-24 Points, higher score is indicating higher satisfaction) and the Roland Morris Disability questionnaire (RMDQ, 0-23 Points, a high score is indicating high disability)

    Cross sectional (< 45 seconds)

  • Test re-test of the Online Patient Satisfaction Index (0-24 Points, higher score is indicating higher satisfaction)

    One week

  • Association between the Online Patient Satisfaction Index (0-24 Points, higher scores indicate higher satisfaction) and global rating of satisfaction (10-0 Points, 10-9 Points is categorised as satisfied and 8-0 Points is categorised as not satisfied)

    Cross sectional (< 45 seconds)

Interventions

A questionnaire to measure satisfaction with online information for patients with low back pain

Also known as: The Online Patient Satisfaction Index

Eligibility Criteria

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

Adult patients with low back pain during the last year. Patients are recruited from social media and The SANO centre, a rehabilitation center for patients with musculoskeletal pain conditions. If recruitment will be difficult we will combine with recruitment from poster in waiting rooms at primary care physicians, physiotherapists, and/or chiropractors.

You may not qualify if:

  • no internet access
  • pregnant women
  • not able to speak/read Danish
  • spinal stenosis
  • serious underlying disease for low back pain (e.g. signs of fracture, cauda equina syndrome, malignancy, osteoporosis, or spondyloarthritis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit for General Practice in Aalborg

Aalborg, 9220, Denmark

Location

Related Publications (10)

  • Kent PM, Keating JL. The epidemiology of low back pain in primary care. Chiropr Osteopat. 2005 Jul 26;13:13. doi: 10.1186/1746-1340-13-13.

    PMID: 16045795BACKGROUND
  • Croft PR, Macfarlane GJ, Papageorgiou AC, Thomas E, Silman AJ. Outcome of low back pain in general practice: a prospective study. BMJ. 1998 May 2;316(7141):1356-9. doi: 10.1136/bmj.316.7141.1356.

    PMID: 9563990BACKGROUND
  • Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.

    PMID: 21665125BACKGROUND
  • Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.

    PMID: 21982256BACKGROUND
  • National Guideline Centre (UK). Low Back Pain and Sciatica in Over 16s: Assessment and Management. London: National Institute for Health and Care Excellence (NICE); 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK401577/

    PMID: 27929617BACKGROUND
  • Diaz JA, Griffith RA, Ng JJ, Reinert SE, Friedmann PD, Moulton AW. Patients' use of the Internet for medical information. J Gen Intern Med. 2002 Mar;17(3):180-5. doi: 10.1046/j.1525-1497.2002.10603.x.

    PMID: 11929503BACKGROUND
  • Tustin N. The role of patient satisfaction in online health information seeking. J Health Commun. 2010 Jan;15(1):3-17. doi: 10.1080/10810730903465491.

    PMID: 20390974BACKGROUND
  • A. Riis, M. B. Jensen, A. M. Kanstrup, J. Hartvigsen, M. S. Rathleff, D. M. Hjelmager, L. D. Vinther, and P. Bertelsen, "Tailored on-line information and advice to patients with low back pain in general practice," 2016.

    BACKGROUND
  • Deyo RA, Diehl AK. Patient satisfaction with medical care for low-back pain. Spine (Phila Pa 1976). 1986 Jan-Feb;11(1):28-30. doi: 10.1097/00007632-198601000-00008.

    PMID: 2939566BACKGROUND
  • Afzali T, Lauridsen HH, Thomsen JL, Hartvigsen J, Jensen MB, Riis A. The Online Patient Satisfaction Index for Patients With Low Back Pain: Development, Reliability, and Validation Study. JMIR Form Res. 2021 Nov 15;5(11):e21462. doi: 10.2196/21462.

MeSH Terms

Conditions

Low Back PainPersonal Satisfaction

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Janus L Thomsen, PhD

    Research unit for General Practice in Aalborg, Denmark

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

February 14, 2018

First Posted

February 28, 2018

Study Start

March 19, 2018

Primary Completion

May 15, 2019

Study Completion

May 15, 2019

Last Updated

May 31, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations