VR for Patients With Chronic Pain (Wait & Work)

March 15, 2024 updated by: Monique Tabak, University of Twente

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Friesland
      • Emmeloord, Friesland, Netherlands, 8303BX
        • Recruiting
        • Revalidatie Friesland
        • Contact:
          • Heleen Reinders-Messelink, PhD
    • Overijssel
      • Deventer, Overijssel, Netherlands, 7416SE
        • Recruiting
        • Deventer Ziekenhuis
        • Contact:
          • Leonie Oolbekkink, MSc
      • Enschede, Overijssel, Netherlands, 7522AH
        • Recruiting
        • Roessingh rehabilitation center
        • Contact:
          • Marjolein Stegeman, MSc
      • Hengelo, Overijssel, Netherlands, 7555DL
        • Recruiting
        • Nocepta
        • Contact:
          • Nelson Oliveira, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Four-week, at-home VR intervention with a recommended daily use of 10-30 minutes
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.
No Intervention: Control group
No intervention, patient is a waiting-list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life measured using the short-form 12 (SF-12)
Time Frame: Baseline, directly after the intervention, and at six months follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity measured using the numeric pain rating scale (NPRS)
Time Frame: Baseline, directly after the intervention, and at six months follow-up
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
Change in pain catastrophizing measured using the pain catastrophizing scale (PCS)
Time Frame: Baseline, directly after the intervention, and at six months follow-up
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
Change in pain self-efficacy measured using the pain self-efficacy questionnaire (PSEQ)
Time Frame: Baseline, directly after the intervention, and at six months follow-up
This questionnaire scores from 0 (worst possible score) to 60 (best possible score).
Baseline, directly after the intervention, and at six months follow-up
Change in pain acceptance measured using the chronic pain acceptance questionnaire (CPAQ-8)
Time Frame: Baseline, directly after the intervention, and at six months follow-up
This questionnaire scores from 0 (worst possible score) to 48 (best possible score).
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)
Time Frame: Baseline, directly after the intervention, and at six months follow-up
This questionnaire scores from 0 (worst possible score) to 42 (best possible score).
Baseline, directly after the intervention, and at six months follow-up
Change in quality of care measured using the client satisfaction questionnaire (CSQ-8)
Time Frame: Baseline, directly after the intervention, and at six months follow-up
This questionnaire scores from 8 (worst possible score) to 32 (best possible score).
Baseline, directly after the intervention, and at six months follow-up
Change in medication use measured using an open-ended question
Time Frame: Baseline, directly after the intervention, and at six months follow-up
This question inquires about current medication use
Baseline, directly after the intervention, and at six months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Twente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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