Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06282757
• Other study ID #: 202302
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: HAN University of Applied Sciences
• Contact: Syl Slatman, MSc
• Phone: +31629684200
• Email: syl.slatman[@]han.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Communication

Intervention

Other:
• Video placebo communication
The placebo communication video comprises of an educational VR video containing placebo enhancing verbal language.
• Video nocebo communication
The nocebo communication video comprises of an educational VR video containing nocebo stimulating verbal language.

Locations

Country	Name	City	State
Netherlands	HAN University of Applied Sciences	Nijmegen	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
HAN University of Applied Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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