Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP

NCT ID: NCT06282757

Last Updated: 2025-09-16

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

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-06-30

Brief Summary

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Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered non-pharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in patients with CMP.

Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in patients with CMP

Study design: Web-based randomized controlled trial.

Study population: 100 participants

Intervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.

Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ).

Detailed Description

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Conditions

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Communication Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo group

The placebo intervention group will be shown an online educational VR video.

Group Type EXPERIMENTAL

Video placebo communication

Intervention Type OTHER

The placebo communication video comprises of an educational VR video containing placebo enhancing verbal language.

Nocebo group

The nocebo intervention group will be shown an online educational VR video.

Group Type ACTIVE_COMPARATOR

Video nocebo communication

Intervention Type OTHER

The nocebo communication video comprises of an educational VR video containing nocebo stimulating verbal language.

Interventions

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Video placebo communication

The placebo communication video comprises of an educational VR video containing placebo enhancing verbal language.

Intervention Type OTHER

Video nocebo communication

The nocebo communication video comprises of an educational VR video containing nocebo stimulating verbal language.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* aged ≥ 18
* access to the internet
* provide informed consent
* suffers from CMP

Exclusion Criteria

* lacked comprehension of the Dutch language
* had experience with therapeutic VR
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HAN University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Bart Staal

Professor (lector)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bart Staal, PhD

Role: PRINCIPAL_INVESTIGATOR

HAN University of Applied Sciences

Locations

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HAN University of Applied Sciences

Nijmegen, Overijssel, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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202302

Identifier Type: -

Identifier Source: org_study_id

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