Clinical trial NCT05822947: Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students
Official title: Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students: a Blinding Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Back Disorder
Back Pain, Low
Keywords: Methods
Manual therapy
Randomised trial
Back pain
Feasibility
Blinding assessment
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2023-04-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single centre, two-parallel group, blinding feasibility randomized controlled trial.
Primary purpose: OTHER

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 Ph.D. 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* enrolled in a doctoral-level epidemiology course at the University of Zurich, Switzerland.

Exclusion Criteria:

* serious pathology (i.e., cancer, severe scoliosis, inflammatory disease, infection, cauda equina syndrome or progressive motor deficit)
* history of spine surgery
* obvious contraindication to manual therapy (i.e., spinal fracture)

Primary outcomes:
measure: Blinding feasibility of participants, measured by the Bang blinding index.
timeFrame: Immediately after the one-time intervention session (study day 1).
Secondary outcomes:
measure: Blinding feasibility of participants, measured by the James blinding index.
timeFrame: Immediately after the one-time intervention session (study day 1).
measure: Blinding feasibility of outcome assessors, measured by the Bang blinding index.
timeFrame: Immediately after the one-time intervention session (study day 1).
measure: Factors contributing to perceived intervention arm allocation among study participants.
timeFrame: Immediately after the one-time intervention session (study day 1).
measure: Factors contributing to perceived intervention arm allocation among outcome assessors.
timeFrame: Immediately after the one-time intervention session (study day 1).
measure: Blinding feasibility of outcome assessors, measured by the James blinding index.
timeFrame: Immediately after the one-time intervention session (study day 1).
Other outcomes:
measure: Back function - self-reported flexibility, immediately before the one-time intervention session.
timeFrame: Immediately before the one-time intervention session (study day 1).
measure: Back function - self-reported flexibility, immediately after the one-time intervention session.
timeFrame: Immediately after the one-time intervention session (study day 1).
measure: Back function - self-reported ache, pain, discomfort in the upper back, immediately before the one-time intervention session.
timeFrame: Immediately before the one-time intervention session (study day 1).
measure: Back function - self-reported ache, pain, discomfort in the upper back, immediately after the one-time intervention session.
timeFrame: Immediately after the one-time intervention session (study day 1).
measure: Back function - self-reported ache, pain, discomfort in the lower back, immediately before the one-time intervention session.
timeFrame: Immediately before the one-time intervention session (study day 1).
measure: Back function - self-reported ache, pain, discomfort in the lower back, immediately after the one-time intervention session.
timeFrame: Immediately after the one-time intervention session (study day 1).
measure: Lumbar spine range of motion, immediately before the one-time intervention session.
timeFrame: Immediately before the one-time intervention session (study day 1).
measure: Lumbar spine range of motion, immediately after the one-time intervention session.
timeFrame: Immediately after the one-time intervention session (study day 1).
measure: Change in lumbar spine range of motion, difference between after and before intervention measurements.
timeFrame: Immediately before and after the one-time intervention session (study day 1).
Locations:
city: Zürich
country: Switzerland
facility: University of Zurich
state: Zurich
Study officials:
affiliation: Balgrist University Hospital and University of Zurich
name: Cesar A Hincapié, DC PhD
role: PRINCIPAL_INVESTIGATOR
References: