Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP

The Effect of Physiotherapists' Placebo or Nocebo Communication About Virtual Reality on Treatment Beliefs in Patients With CMP

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).

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Communication
• Intervention / Treatment: Other: Video placebo communication; Other: Video nocebo communication

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Nijmegen, Overijssel, Netherlands, 6525EN
      • HAN University of Applied Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo group; The placebo intervention group will be shown an online educational VR video.	Other: Video placebo communication; The placebo communication video comprises of an educational VR video containing placebo enhancing verbal language.
Active Comparator: Nocebo group; The nocebo intervention group will be shown an online educational VR video.	Other: Video nocebo communication; The nocebo communication video comprises of an educational VR video containing nocebo stimulating verbal language.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ)	This questionnaire on treatment expectancy scores from 6 (lowest expectancy) to 54 (highest expectancy)	Baseline and immediately after the intervention
Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ)	This questionnaire on treatment credibility scores from 5 (lowest credibility) to 45 (highest credibility)	Baseline and immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in openness to VR measured using a single question	The question "would you be open to treatment with therapeutic VR" was scored with a yes/no	Baseline and immediately after the intervention
Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)	This questionnaire on pain intensity scores from 0 (no pain) to 10 (maximal pain)	Baseline and immediately after the intervention

Collaborators and Investigators

• Sponsor: HAN University of Applied Sciences
• Investigators: Principal Investigator: Bart Staal, PhD, HAN University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Chronic Pain; Communication
• Other Study ID Numbers: 202302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not planned to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No