Low Back Pain Clinical Trial
Official title:
Effect of an E-learning Intervention on Knowledge, Attitudes and Beliefs of Healthcare Professionals Managing Low Back Pain: a Randomized Controlled Trial With Nested Process Evaluation.
NCT number | NCT05284669 |
Other study ID # | 20/51/714 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 27, 2021 |
Est. completion date | March 1, 2023 |
Verified date | May 2023 |
Source | Universiteit Antwerpen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the current research project is to examine if the healthcare professionals (HCPs) knowledge, attitudes, beliefs and behavior about the management of low back pain (LBP) patients changes following an e-learning intervention (experimental interactive e-learning versus traditional non-interactive e-learning)
Status | Completed |
Enrollment | 2720 |
Est. completion date | March 1, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - To be an healthcare practitioner (general practitioner, physiotherapist, specialist physician, student in medicine including specialization, student in physiotherapy) - Working or studying in Belgium or France - Being in possession of an internet connected device (e.g. computer, tablet or smartphone) with speaker |
Country | Name | City | State |
---|---|---|---|
Belgium | Online study | Brussels |
Lead Sponsor | Collaborator |
---|---|
Antoine Fourré | Universiteit Antwerpen, University of Mons, University of Picardie Jules Verne |
Belgium,
Fourre A, Fierens A, Michielsen J, Ris L, Dierick F, Roussel N. An interactive e-learning module to promote bio-psycho-social management of low back pain in healthcare professionals: a pilot study. J Man Manip Ther. 2022 Apr;30(2):105-115. doi: 10.1080/10 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Health Care Providers Pain and Impairment Relationship Scale (HC-PAIRS) | The HC-PAIRS assesses attitudes and beliefs about functional expectations for patients with chronic LBP. It consists of 13 statements that must be rated on a seven-point Likert scale, ranging from 'totally disagree' to 'totally agree'. A high score on the HC-PAIRS reflects a belief with a strong relationship between pain and impairment. Psychometric properties of this questionnaire have been established. | Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline) | |
Primary | Vignette of Rainville | The clinical vignette described a patient with non-specific LBP. This vignette was developed by Rainville. Participants were asked to assess the patient's ability to work, from 1 (full-time) to 5 (remain out of work) and gave their opinion on the appropriate level of activity, with choices graded from 1 (no limitations on activity) to 5 (limit all physical activity). If the score of the participant was between 1 and 2 it was considered guideline adherent. If the score was between 3 and 5 it was considered guidelines discordant. | Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline) | |
Secondary | The Back Pain and Attitudes Questionnaire (Back-PAQ ; 10-items version) | The Back-PAQ questionnaire (10 items version) assesses attitudes and underlying beliefs about back pain on a 5-point Likert scale. The scoring of the answers ranges from -2 to +2. A negative score reflects beliefs that are unhelpful and vice-versa. All items were written in the second person to personalize the questionnaire. The purpose of this personalization is that HCPs or students present their own beliefs rather than projecting their beliefs onto people with LBP or presenting their beliefs about people with LBP. | Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline) | |
Secondary | The Neurophysiology of Pain Questionnaire (NPQ) | The Neurophysiology of pain questionnaire (NPQ) assesses how an individual conceptualizes biological mechanisms underpinning pain. The NPQ includes 19 questions with three answer options (true; undecided; false). The scoring is 1 for a correct answer and 0 if the participant was wrong or undecided. This questionnaire was included to reflect recommendations of the guidelines for the management of LBP that encourages clinicians to explain and reassure the patient about their personal experience of pain. | Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline) | |
Secondary | Fictive clinical cases of patients with LBP | 4 clinical cases were developed by a multidisciplinary team of experts in the field (general practitioners, orthopedic surgeons, physiotherapists, and academics). Two cases described the symptoms of a patient with specific LBP and the two others described the symptoms of a patient with non-specific LBP. A specific and non-specific clinical case were presented at baseline and post-intervention assessment. Participants answered 3 open questions related to the clinical case: "In your opinion, what are the causes/contributing factors to the pain of this patient?"; "As an healthcare practitioners what would be your first approach to manage this patient?"; "Which advices would you give to this patient concerning physical activity".
Coding of the answers in a matrix using keywords and themes will be used to analyse the orientation of the healthcare practitioners (guideline adherent or guideline discordant). |
Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline) | |
Secondary | Experiences of HCPs with the e-learning (quantitative) | A Likert scale (1-7) will be used to examine the participants experiences regarding the content and quality of the intervention and the Technology acceptance. The questions of this survey are based on Cheng et al. 2012 and cover global system quality and technology acceptance of the e-learning. Higher score reflects a better experience with the e-learning intervention. | Post-intervention assessment (between 2 and 4 weeks after baseline) | |
Secondary | Experiences of HCPs with the e-learning (qualitative) | A purposive sample of participants agreeing to take part in a phone interview will be invited to an in-depth interview. We foresee to start with 10 HCPs of each group (experimental and traditional e-learning intervention) to provide depth and breadth of experiences and will continue until no new themes emerge (Bowen 2008). The principles of qualitative research will be used to explore how participants experienced the e-learning intervention and which impact had the e-learning on their clinical practice. | Between 4 and 6 weeks after baseline |
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