VR for Patients With Chronic Pain (Wait & Work)

Chronic Pain Clinical Trial

Official title:

Cluster-randomized Controlled Trial of Virtual Reality for Patients With Chronic Musculoskeletal Pain (Wait & Work)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312735
• Other study ID #: 230405
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: University of Twente
• Contact: Syl Slatman, MSc
• Phone: 31534899465
• Email: e.s.slatman[@]utwente.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This cluster-RCT evaluates the effect of therapeutic virtual reality (VR) on patients with chronic musculoskeletal pain (CMP) who are on a waiting list to receive pain treatment. The used VR application, Reducept, offers pain education and pain management techniques. This home-based, stand-alone, immersive VR intervention was used daily for four weeks in the intervention group. The control group received standard care (no treatment). Primary outcome measure for this study was health-related quality of life, secondary outcome measures included various pain-related variables (e.g. pain self-efficacy and acceptance. Outcome variables will be measured after four weeks and follow-up after six months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged 18 years or older

• suffering from primary or secondary CMP

• finished with biomedical diagnostics and treatment

• open to biopsychosocial treatment

• willing and capable of complying with study procedures.

Exclusion Criteria:

• not able to finish the VR intervention due to physical (e.g. visual impairment), mental (e.g. severe sensitivity to stimuli) or practical problems (e.g. insufficient tech-literacy)

• unable to finish Dutch questionnaires.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• VR (Reducept)
Reducept is a novel VR intervention that consists of a combination of pain neuroscience education (PNE) and pain management techniques. It includes different psychological therapy modalities (e.g. acceptance and commitment therapy (ACT), cognitive behavioral therapy (CBT) and hypnotherapy) into a single application.

Locations

Country	Name	City	State
Netherlands	Deventer Ziekenhuis	Deventer	Overijssel
Netherlands	Revalidatie Friesland	Emmeloord	Friesland
Netherlands	Roessingh rehabilitation center	Enschede	Overijssel
Netherlands	Nocepta	Hengelo	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
University of Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life measured using the short-form 12 (SF-12)	This questionnaire on quality of life scores from 12 (worst possible score) to 56 (best possible score)	Baseline, directly after the intervention, and at six months follow-up
Secondary	Change in pain intensity measured using the numeric pain rating scale (NPRS)	This questionnaire on pain intensity scores from 0 (best possible score) to 100 (worst possible score)	Baseline, directly after the intervention, and at six months follow-up
Secondary	Change in pain catastrophizing measured using the pain catastrophizing scale (PCS)	This questionnaire on pain catastrophizing scores from 0 (best possible score) to 52 (worst possible score).	Baseline, directly after the intervention, and at six months follow-up
Secondary	Change in pain self-efficacy measured using the pain self-efficacy questionnaire (PSEQ)	This questionnaire scores from 0 (worst possible score) to 60 (best possible score).	Baseline, directly after the intervention, and at six months follow-up
Secondary	Change in pain acceptance measured using the chronic pain acceptance questionnaire (CPAQ-8)	This questionnaire scores from 0 (worst possible score) to 48 (best possible score).	Baseline, directly after the intervention, and at six months follow-up
Secondary	Change in feelings of anxiety and depression measured using the hospital anxiety and depression scale (HADS)	This questionnaire scores from 0 (worst possible score) to 42 (best possible score).	Baseline, directly after the intervention, and at six months follow-up
Secondary	Change in quality of care measured using the client satisfaction questionnaire (CSQ-8)	This questionnaire scores from 8 (worst possible score) to 32 (best possible score).	Baseline, directly after the intervention, and at six months follow-up
Secondary	Change in medication use measured using an open-ended question	This question inquires about current medication use	Baseline, directly after the intervention, and at six months follow-up