NCT06312735

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

March 8, 2024

Last Update Submit

April 8, 2025

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in pain intensity measured using the numeric pain rating scale (NPRS)

    Baseline, directly after the intervention, and at six months follow-up

  • Change in pain catastrophizing measured using the pain catastrophizing scale (PCS)

    Baseline, directly after the intervention, and at six months follow-up

  • Change in pain self-efficacy measured using the pain self-efficacy questionnaire (PSEQ)

    Baseline, directly after the intervention, and at six months follow-up

  • Change in pain acceptance measured using the chronic pain acceptance questionnaire (CPAQ-8)

    Baseline, directly after the intervention, and at six months follow-up

  • Change in feelings of anxiety and depression measured using the hospital anxiety and depression scale (HADS)

    Baseline, directly after the intervention, and at six months follow-up

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Four-week, at-home VR intervention with a recommended daily use of 10-30 minutes

Device: VR (Reducept)

Control group

NO INTERVENTION

No intervention, patient is a waiting-list control

Interventions

VR (Reducept)DEVICE

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Deventer Ziekenhuis

Deventer, Overijssel, 7416SE, Netherlands

Location

Roessingh rehabilitation center

Enschede, Overijssel, 7522AH, Netherlands

Location

Nocepta

Hengelo, Overijssel, 7555DL, Netherlands

Location

Revalidatie Friesland

Emmeloord, Provincie Friesland, 8303BX, Netherlands

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 15, 2024

Study Start

October 1, 2023

Primary Completion

April 30, 2024

Study Completion

November 30, 2024

Last Updated

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(4)