Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05822947
Status:
COMPLETED
Last Update Posted:
2023-04-21
First Post:
2023-03-02
Brief Title:
Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students
Sponsor:
Cesar A Hincapié DC PhD
Organization:
Balgrist University Hospital
Study Overview
Official Title:
Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students a Blinding Feasibility Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is marked uncertainty regarding the feasibility of achieving adequate blinding in randomized controlled trials of manual therapy In other words whether participants and outcome assessors can accurately perceive randomly assigned interventions is unclear This feasibility trial was conducted as part of a doctoral epidemiology course at the University of Zurich Switzerland Within the practice-based context of the class and using a study population of healthy graduate students enrolled in the course the investigators aimed to evaluate blinding of participants randomly assigned similar to tossing a coin to one of two manual therapy interventions active versus control The investigators also aimed to assess blinding among outcome assessors
Detailed Description:
Manual therapy remains a guideline-compliant first-line therapeutic option for back pain Yet maintaining methodological quality in randomized controlled trials of manual therapy interventions poses challenges particularly concerning a The design of adequate sham controls and b the blinding status of participants and outcome assessors Optimal implementation of large-scale manual therapy trials requires testing the feasibility of control manual therapy interventions and effective blinding of participants and outcome assessors Even when conducted in healthy populations and non-clinical settings blinding feasibility trials remain an opportunity for methodological advancement in the field of manual medicine and a research priority for unbiased treatment effect estimation in future trials
The primary objective of this methodological trial was to quantitatively assess blinding feasibility among participants graduate students enrolled in an epidemiology PhD course assigned to an active or control intervention immediately after a one-time intervention session The secondary objective was to assess blinding feasibility among outcome assessors and explore factors influencing perceptions about intervention assignment among participants and outcome assessors These two objectives contributed to obtaining valuable preliminary measures of blinding blinding indices for a future methodological blinding feasibility trial to be carried out in a real-world clinical setting
The primary objective of this methodological trial was to quantitatively assess blinding feasibility among participants graduate students enrolled in an epidemiology PhD course assigned to an active or control intervention immediately after a one-time intervention session The secondary objective was to assess blinding feasibility among outcome assessors and explore factors influencing perceptions about intervention assignment among participants and outcome assessors These two objectives contributed to obtaining valuable preliminary measures of blinding blinding indices for a future methodological blinding feasibility trial to be carried out in a real-world clinical setting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None