Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2022-11-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Back Pain Back Disorder Back Pain, Low

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single centre, two-parallel group, blinding feasibility randomized controlled trial.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Blinding was the primary outcome of interest. That said, except for intervention providers, every role was, by protocol, blinded to intervention assignment.

To maintain blinding of participants, candidate participants were formally invited to participate by email, with a study information form that masked the blinding feasibility objective.

The intervention providers were kept in a separate room and could not be blinded but were asked not to disclose the intervention group or the nature of the control MT component to participants, outcome assessors, data analysts, and other members of the study team.

Study Groups

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Active manual therapy

Active manual therapy intervention involved mobilization of the lumbar paraspinal musculature. With participants laying prone on a chiropractic table, the intervention provider administered hand-reinforced circumferential movements to six focal areas, using continuous ischemic compression strokes, and adjusting the pressure to participants' tolerability.

Group Type EXPERIMENTAL

Active manual therapy

Intervention Type OTHER

Soft tissue mobilization of the lumbar paraspinal musculature (3 to 4 minutes).

Control manual therapy

Control MT intervention included light touch to six distal, broad areas of the thoracic region, with a synchronized breathing exercise.

Group Type SHAM_COMPARATOR

Control manual therapy

Intervention Type OTHER

Light touch and a breathing exercise (3 to 4 minutes).

Interventions

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Active manual therapy

Soft tissue mobilization of the lumbar paraspinal musculature (3 to 4 minutes).

Intervention Type OTHER

Control manual therapy

Light touch and a breathing exercise (3 to 4 minutes).

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes