NCT06104995

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Nov 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

October 16, 2023

Last Update Submit

August 12, 2024

Conditions

Keywords

nonspecific low back painback beliefseducation

Outcome Measures

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")

    One minute

Secondary Outcomes (1)

  • Total Back-PAQ-10 score

    Three minutes

Study Arms (2)

Interventional Educational video on back beliefs

EXPERIMENTAL

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

Other: Interventional video

Control Video Education

EXPERIMENTAL

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

Other: Control video

Interventions

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.

Interventional Educational video on back beliefs

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

Control Video Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bern University of Applied Sciences

Bern, Switzerland

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan Schmid, PhD

    Bern UAS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will fill out online questionnaires. No outcome assessor will be present or in contact with the participants. The investigator that will analyse the data will not be aware of which participants are in which group.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head of Research at the Division of Physiotherapy and Head of Spinal Movement Biomechanics Group

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 27, 2023

Study Start

November 15, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations