Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP

NCT06282757 | Completed

• 1 other identifier: 202302
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Communication; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in openness to VR measured using a single question

  Baseline and immediately after the intervention

• Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)

  Baseline and immediately after the intervention

Study Arms (2)

Placebo group

EXPERIMENTAL

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

Other: Video placebo communication

Nocebo group

ACTIVE COMPARATOR

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

Other: Video nocebo communication

Interventions

Video placebo communication OTHER

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

Placebo group

Video nocebo communication OTHER

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

Nocebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• lacked comprehension of the Dutch language
• had experience with therapeutic VR

Sponsors & Collaborators

• HAN University of Applied Sciences: lead

Study Sites (1)

HAN University of Applied Sciences

Nijmegen, Overijssel, 6525EN, Netherlands

Location

MeSH Terms

Conditions

Communication; Chronic Pain

Condition Hierarchy (Ancestors)

Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bart Staal, PhD

  HAN University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (lector)

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: April 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)