NCT07528599

Brief Summary

This study investigated the effects of a virtual reality-based motor imagery intervention integrated into a conventional exercise programme on pain outcomes (pain intensity, central sensitisation, pressure pain threshold, galvanic skin response, pain catastrophising), quality of life, sleep quality, fatigue, psychological outcomes (Hospital Anxiety and Depression Scale), imagery ability and patient satisfaction.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress17%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 25, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 7, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

Fibromyalgiamotor imageryexerciserehabilitationvirtual reality

Outcome Measures

Primary Outcomes (2)

  • pain assessment

    Pain during rest and activity will be assessed using the VAS. The VAS is a 10-cm scale where 0 points indicate 'no pain' and 10 points indicate 'the worst pain imaginable'. Participants will be asked to mark the scale based on their assessment of pain intensity over the past 24 hours. Pain intensity will be measured using the scale and recorded in centimetres.

    baseline

  • pain assessment

    Pain during rest and activity will be assessed using the VAS. The VAS is a 10-cm scale where 0 points indicate 'no pain' and 10 points indicate 'the worst pain imaginable'. Participants will be asked to mark the scale based on their assessment of pain intensity over the past 24 hours. Pain intensity will be measured using the scale and recorded in centimetres.

    6 weeks

Secondary Outcomes (20)

  • Pressure Pain Threshold Assessment

    Baseline

  • Pressure pain threshold assessment

    6 weeks

  • Galvanic Skin Response

    Baseline

  • Galvanic Skin Response

    6 weeks

  • Central Sensitivity Inventory

    Baseline

  • +15 more secondary outcomes

Study Arms (2)

conventional exercise + motor imagery without virtual reality

ACTIVE COMPARATOR

Participants will undergo a traditional rehabilitation programme three days a week under the supervision of a physiotherapist. Three virtual reality games targeting the upper limbs, trunk and lower limbs will be used; participants will watch these games on a monitor and visualise the movements.

Other: conventional exercise + motor imagery without virtual reality

conventional exercise + motor imagery with virtual reality

EXPERIMENTAL

Participants will undergo a traditional rehabilitation programme three days a week under the supervision of a physiotherapist. Participants will watch three virtual reality games, each lasting three minutes and targeting the upper limbs, trunk and lower limbs, and will then perform motor imagery for two minutes.

Other: conventional exercise + motor imagery with virtual reality

Interventions

A structured conventional exercise programme will be implemented three days a week for six weeks. The conventional exercise programme has been designed to include components of stretching, postural control and muscle strengthening. Each session will last approximately 30 minutes. The intensity and difficulty level of the exercises will be gradually increased every two weeks and progressed in a controlled manner. In the experimental group, motor imagery exercises will be performed by creating a virtual environment using the provided virtual reality headset. In this group, a total of three different virtual reality games targeting the upper limbs, trunk and lower limbs will be used. Each game will be viewed for three minutes via the virtual reality headset, after which participants will be asked to mentally visualise the relevant movements for two minutes. The total duration of the motor imagery intervention is planned to be 15 minutes.

Also known as: experimental group
conventional exercise + motor imagery with virtual reality

Participants in the control groups will undergo a structured conventional exercise programme under the supervision of a physiotherapist, three days a week for six weeks. The conventional exercise programme has been designed to include stretching, postural control and muscle strengthening components. Each session will last approximately 30 minutes. The intensity and difficulty level of the exercises will be gradually increased every two weeks and progressed in a controlled manner. In the control group, recorded versions of virtual reality games will be presented via a standard monitor screen without the use of a virtual reality headset. Participants will watch each video for three minutes and will then be asked to visualise the same movements for two minutes. The total duration of the motor imagery intervention in the control group will also be 15 minutes.

Also known as: control group
conventional exercise + motor imagery without virtual reality

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • To be a volunteer,
  • To have been diagnosed with fibromyalgia according to the 2016 ACR diagnostic criteria,
  • To be aged between 18 and 60,
  • To have had pain symptoms for at least 3 months,
  • To be receiving standard medical treatment,

You may not qualify if:

  • The presence of neurological or orthopaedic conditions that would prevent participation in the rehabilitation programme
  • Pregnancy,
  • The presence of cognitive impairments that could affect cooperation,
  • The presence of serious, uncontrolled health problems,
  • A history of lower limb or spinal surgery
  • Visual or hearing impairments;
  • Serious psychiatric disorders
  • A diagnosis of migraine
  • Regular physical exercise in the last three months (≥2 days per week)
  • Participation in any concurrent physiotherapy or rehabilitation intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FibromyalgiaMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

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
Assistant Professor

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations