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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06104995
Other study ID # BernUASBackBeliefs
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date May 19, 2024

Study information

Verified date October 2023
Source Bern University of Applied Sciences
Contact Stefan Schmid, PhD
Phone +41 31 848 45 41
Email stefan.schmid@bfh.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the current study we aim to evaluate the effects of a short educational video on improving the belief that "the back is fragile and needs to be protected" among the German speaking Swiss general population. We hypothesize that a short video education program can positively change the assessed back belief among the German speaking general population of Switzerland. To evaluate the outcomes, we will use the 10-item version of the Back Pain Attitude Questionnaire (Back-PAQ). The primary outcome is the second question of the Back-PAQ-10 ("You could injure your back if you are not careful"). The secondary outcome of this study is the total score of the Back-PAQ-10. The design of the present study is a two-group randomized controlled trial, with one intervention and one control group in a 1:1 allocation.


Description:

This study will be conducted in collaboration with HESAV (Haute Ecole de Sante Vaud). The research group at the HESAV has developed an educational website in 2020, called "www.infomaldedos.ch". The website aims to educate people on low back pain, and common unhelpful beliefs about the back - primarily targeting the belief about the fragility of the back and the need for its protection - are addressed. In the current study we are going to translate the above-mentioned website to the German language. Furthermore, we are going to assess the quality and applicability of a short video intervention among the general population, using one of the videos from the website. Participants will be recruited through social media and emails. A link will be created to the questionnaire and the educational video with LimeSurvey. A 'randomizer' built-in function will be used to blindly split people into intervention or control group. The link will be spread on social media platforms and through email. To induce a snowball sampling method, all participants will be asked to send the link further. The length of the video intervention is 3 minutes. In the video, health care professionals, such as a psychologist, a medical doctor, a professor, and physiotherapist interviewed by a scientist explains the burden of LBP, how unhelpful beliefs affect treatment outcome, difficulties in the management of LBP and the optimal way of treating LBP. The scientist then inquires a representative patient about their own experiences of the management of LBP. At the end of the video the scientist encourages people to exercise despite LBP by performing various movements. The control group will receive a neutral video about the back, selected from YouTube.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date May 19, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >18 years Exclusion Criteria: - Professionals and students with prior knowledge on the topic of interest such as physiotherapists, osteopaths, and chiropractors.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interventional video
The educational video comprises of health care professionals explaining the durability of the back against the popular belief that the back is fragile and the multifactorial nature of back pain.
Control video
The control video is a neutral video with no content addressing back beliefs (fragility and need for protection).

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Bern University of Applied Sciences Haute Ecole de Santé Vaud

Outcome

Type Measure Description Time frame Safety issue
Primary Sentiments about back vulnerability The primary outcome is the second question of the Back-PAQ-10 ("You could injure your back if you are not careful") One minute
Secondary Total Back-PAQ-10 score The secondary outcome of this study is the total score of the German version of the Back-PAQ-10. Three minutes
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