CClinicalTrials.gg
CompletedNCT06104995Updated Aug 13, 2024

Back Beliefs Among the General Population

An interventional study of Interventional video and Control video in Low Back Pain, sponsored by Bern University of Applied Sciences. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Bern University of Applied Sciences · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
232
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Low Back Pain

Keywords

  • nonspecific low back pain
  • back beliefs
  • education
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age >18 years

Exclusion criteria

Exclusion Criteria:

  • Professionals and students with prior knowledge on the topic of interest such as physiotherapists, osteopaths, and chiropractors.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
232 participants (actual)

Study arms

  • Experimental
    Interventional Educational video on back beliefs

    Participants receive an educational video on back beliefs and its contributing factors.

    Other: Interventional video

  • Experimental
    Control Video Education

    Participants receive a neutral video about the back (e.g. anatomy of the back).

    Other: Control video

Interventions

  • OtherInterventional 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.

  • OtherControl video

    The control video is a neutral video with no content addressing back beliefs (fragility and need for protection).

05

What researchers measure

Primary outcomes

  1. 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")

    Time frame: One minute

Secondary outcomes

  1. Total Back-PAQ-10 score

    The secondary outcome of this study is the total score of the German version of the Back-PAQ-10.

    Time frame: Three minutes

06

Study locations

1 site
  • Bern University of Applied Sciences
    Bern, Switzerland
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06104995
Lead sponsor
Bern University of Applied Sciences
Collaborators
Haute Ecole de Santé Vaud
Responsible party
Stefan Schmid (Deputy Head of Research at the Division of Physiotherapy and Head of Spinal Movement Biomechanics Group, Bern University of Applied Sciences) — Principal investigator
First posted
Oct 27, 2023
Start date
Nov 15, 2023
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Last update
Aug 13, 2024

Study contacts

Stefan Schmid, PhD
principal investigator · Bern UAS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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