NCT07742111

Brief Summary

This is a single-case experimental design study enrolling individuals with chronic low back pain who will be receiving pain science education and virtual reality over 3 weeks.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
1mo left

Started May 2026

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress86%
May 2026Oct 2026

First Submitted

Initial submission to the registry

April 9, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

April 9, 2026

Last Update Submit

July 28, 2026

Conditions

Low Back Pain

Keywords

Low back painVirtual realityPain science education

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.

    Baseline (Day 1)

  • Pain intensity

    Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.

    Daily (from day 1 to day 35)

  • Pain intensity

    Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.

    End of the intervention (day 35)

Secondary Outcomes (13)

  • pain mechanism

    Baseline (day 1)

  • pain mechanism

    End of the intervention (day 35)

  • Pain intensity during movement

    Baseline (day 1)

  • Pain intensity during movement

    End of the intervention (day 35)

  • Perceived disability

    Baseline (day 1)

  • +8 more secondary outcomes

Other Outcomes (2)

  • Catastrophizing

    Daily (from day 1 to day 35)

  • Fear of movemently

    Daily (from day 1 to day 35)

Study Arms (1)

Virtual reality and pain science education

EXPERIMENTAL

There is only one arm. Participants will receive pain science education and virtual reality. This is a single case experimental design study.

Other: Pain science education and virtual reality

Interventions

Pain science education and virtual realityOTHER

The intervention period will take place between the 5th and the 29th day of the study (i.e., 3 weeks), noting that each participant will have a specific day to start the intervention. Three sessions will be conducted per week, with a total of 6 to 10 sessions per participant. The first 6 sessions will last 45 minutes, and the remaining 4 sessions will last 30 minutes. The sessions will combine Pain Neuroscience Education (PNE) and Virtual Reality (VR) using the Meta Quest 3S.

Virtual reality and pain science education

Eligibility Criteria

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

You may qualify if:

  • Individuals with primary chronic low back pain aged ≥18 years, who present a moderate pain intensity (≥4 on the Numeric Pain Rating Scale) and a mild level of fear of movement.

You may not qualify if:

  • have a diagnosis of spondylolisthesis or lumbar spinal stenosis;
  • are experiencing an exacerbation of low back pain symptoms at the time of screening;
  • present with constant and widespread nonspecific pain;
  • are in an active phase of rheumatoid arthritis;
  • have a progressive neurological disease;
  • are currently pregnant or within 6 months postpartum;
  • have a diagnosed psychiatric disorder;
  • have a malignant disease;
  • have serious cardiac conditions;
  • have contraindications to physical exercise in general;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Community

Amarante, 4600, Portugal

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anabela Silva, PhD

    University of Aveiro

    STUDY CHAIR

Central Study Contacts

Anabela Silva, PhD

CONTACT

+351 234247119asilva@ua.pt

Emanuel Leite, BSc

CONTACT

+351 234401558emanuelleite@ua.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single case experimental design study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 9, 2026

First Posted

August 3, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

August 3, 2026

Record last verified: 2026-07

Locations

PT(1)