Low Back PainNCT03449004
Development and Validation of the Online Patient Satisfaction Index
An observational study of Low Back Pain, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Validation of the OPSI questionnaire
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Mar 2018to 15 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- During the last year experienced LBP of any pain intensity. Regardless of present pain at inclusion.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Online Patient Satisfaction Index (OPSI): Development and Validation Among Patients With Low Back Pain
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.
Read the detailed description
BACKGROUND Low back pain (LBP) is highly prevalent and a frequent reason for patients to consult general practice. It is a common pain condition affecting both men and women at all ages. LBP is rarely caused by only one specific factor but is eventually caused by multiple and often unknown factors. This makes it difficult to perform a precise diagnosis based on a single cause and for most patients, the LBP is diagnosed as nonspecific with or without nerve root compression.
Patient education and information is a cornerstone in the management of LBP. Providing information to patients is considered a crucial issue as it is necessary to support self-management. However, the delivery of evidence based information by a healthcare professional is time consuming and not straight forward to deliver during the available consultation time in general practice.
The internet is a widely accessible source of medical information to patients and offer a range of information provided by a variety of different sources. It has been reported that about 50% of patients use internet search for health and medical advice, and evidence suggests that patients willingness to use this source to obtain information about their health is increasing. The advance of new technologies offer new opportunities to the delivery of patient information on private computers, tablets, and smartphones. Online information can be considered an inexpensive solution to extend the combined treatment in general practice. Therefore, future optimization of information delivery has the potential to increase the delivery of evidence-based treatment of LBP which may lead to better patient outcomes. Patient satisfaction has been suggested as an important domain when evaluating the provision of online information.
Measuring patient satisfaction is a recommended outcome measure when evaluating the effect of interventions for LBP. Furthermore, patient satisfaction may be associated with compliance to the recommended treatment. Patient satisfaction is, however, rarely applied as the primary outcome in studies of LBP. To the investigators' knowledge, there exist no instrument to evaluate specific satisfaction with information delivered online for LBP. The aim of this study is to develop and validate a new questionnaire to inform about patients' satisfaction with online information for LBP.
METHODS This is a development and validation study of a patient reported questionnaire to (1) inform about the discrepancy in satisfaction of online information for LBP between groups and (2) to evaluate changes in satisfaction over time. The conceptualization is based on a formative model, which assumes a causal relationship between different domains of satisfaction with online information and the construct of patients' combined index score of satisfaction. The first version of the instrument was based on findings from an interview study among patients consulting for LBP in Danish general practice. Data for further developing on the first version were exclusively collected for piloting and validating the instrument.
HYPOTHESIS The OPSI index scores among patients categorised as promoters will be compared to the OPSI index scores of patients categorised as non-promotors on the Net Promotor Score. Based on results from the pilot test. It is hypothesised that promotors will have an OPSI score of minimum 2.5 points more than non-promotors (0-8 Points on the Net Promotor Score).
- Conditions
- Low Back Pain
- Being tested
- Validation of the OPSI questionnaire
- Keywords
- Validation, questionnaire, satisfaction, online information
- Medical subject headings
- Low Back Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of the OPSI questionnaireOther
Also called The Online Patient Satisfaction Index
A questionnaire to measure satisfaction with online information for patients with low back pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Discriminant validity
Measured: Cross sectional (< 45 seconds)
Test re-test of the Online Patient Satisfaction Index (0-24 Points, higher score is indicating higher satisfaction)
Reliability (subpopulation of 50 patients)
Measured: 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)
Convergent validity
Measured: Cross sectional (< 45 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start19 Mar 2018
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Allan Riis, Aalborg University Hospital
- Investigators
- Janus L Thomsen, PhD, Study chair, Research unit for General Practice in Aalborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449004
- Sponsor's protocol ID
- AllanRiis_10
- Other IDs
- TamanaAfzali
- Status last verified
- May 2019
- First submitted
- 14 Feb 2018
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16045795Croft 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.
PubMed 9563990Hoy 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.
PubMed 21665125Balague 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.
PubMed 21982256National 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/
PubMed 27929617Diaz 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.
PubMed 11929503Tustin N. The role of patient satisfaction in online health information seeking. J Health Commun. 2010 Jan;15(1):3-17. doi: 10.1080/10810730903465491.
PubMed 20390974A. 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.
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.
PubMed 2939566Afzali 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.
PubMed 34779785
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Online Patient Satisfaction Index (OPSI): Development and Validation Among Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT03449004
- Acronym / sponsor ID
- AllanRiis_10
- Conditions
- Low Back Pain
- Keywords
- Validation, questionnaire, satisfaction, online information
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND Low back pain (LBP) is highly prevalent and a frequent reason for patients to consult general practice. It is a common pain condition affecting both men and women at all ages. LBP is rarely caused by only one specific factor but is eventually caused by multiple and often unknown factors. This makes it difficult to perform a precise diagnosis based on a single cause and for most patients, the LBP is diagnosed as nonspecific with or without nerve root compression.
Patient education and information is a cornerstone in the management of LBP. Providing information to patients is considered a crucial issue as it is necessary to support self-management. However, the delivery of evidence based information by a healthcare professional is time consuming and not straight forward to deliver during the available consultation time in general practice.
The internet is a widely accessible source of medical information to patients and offer a range of information provided by a variety of different sources. It has been reported that about 50% of patients use internet search for health and medical advice, and evidence suggests that patients willingness to use this source to obtain information about their health is increasing. The advance of new technologies offer new opportunities to the delivery of patient information on private computers, tablets, and smartphones. Online information can be considered an inexpensive solution to extend the combined treatment in general practice. Therefore, future optimization of information delivery has the potential to increase the delivery of evidence-based treatment of LBP which may lead to better patient outcomes. Patient satisfaction has been suggested as an important domain when evaluating the provision of online information.
Measuring patient satisfaction is a recommended outcome measure when evaluating the effect of interventions for LBP. Furthermore, patient satisfaction may be associated with compliance to the recommended treatment. Patient satisfaction is, however, rarely applied as the primary outcome in studies of LBP. To the investigators' knowledge, there exist no instrument to evaluate specific satisfaction with information delivered online for LBP. The aim of this study is to develop and validate a new questionnaire to inform about patients' satisfaction with online information for LBP.
METHODS This is a development and validation study of a patient reported questionnaire to (1) inform about the discrepancy in satisfaction of online information for LBP between groups and (2) to evaluate changes in satisfaction over time. The conceptualization is based on a formative model, which assumes a causal relationship between different domains of satisfaction with online information and the construct of patients' combined index score of satisfaction. The first version of the instrument was based on findings from an interview study among patients consulting for LBP in Danish general practice. Data for further developing on the first version were exclusively collected for piloting and validating the instrument.
HYPOTHESIS The OPSI index scores among patients categorised as promoters will be compared to the OPSI index scores of patients categorised as non-promotors on the Net Promotor Score. Based on results from the pilot test. It is hypothesised that promotors will have an OPSI score of minimum 2.5 points more than non-promotors (0-8 Points on the Net Promotor Score).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- During the last year experienced LBP of any pain intensity. Regardless of present pain at inclusion.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation of the OPSI questionnaireAlso: The Online Patient Satisfaction IndexA questionnaire to measure satisfaction with online information for patients with low back pain | Other | – |
Primary outcome
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)
Time frame: Cross sectional (< 45 seconds)
Convergent validity
3 secondary outcomes
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)
Time frame: Cross sectional (< 45 seconds)
Test re-test of the Online Patient Satisfaction Index (0-24 Points, higher score is indicating higher satisfaction)
Time frame: 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)
Time frame: Cross sectional (< 45 seconds)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Background: PubMed 16045795Kent 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.
- Background: PubMed 9563990Croft 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.
- Background: PubMed 21665125Hoy 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.
- Background: PubMed 21982256Balague 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.
- Background: PubMed 27929617National 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/
- Background: PubMed 11929503Diaz 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.
- Background: PubMed 20390974Tustin N. The role of patient satisfaction in online health information seeking. J Health Commun. 2010 Jan;15(1):3-17. doi: 10.1080/10810730903465491.
- BackgroundA. 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: PubMed 2939566Deyo 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.
- Derived from this study: PubMed 34779785Afzali 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.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janus L Thomsen, PhD study chair
Research unit for General Practice in Aalborg, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Cross sectional (< 45 seconds)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03449004, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.