Virtual Reality as a Treatment Tool for Chronic Neck Pain in Patients With Fibromyalgia

NCT ID: NCT05933941

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-02-01

Brief Summary

Fibromyalgia (FM) is a disease characterized by widespread pain, fatigue and cognitive alterations, among other symptoms, neck pain being the most frequent and debilitating. Virtual reality (VR) has emerged as a breakthrough for the treatment of such chronic conditions. The objective of this study is to evaluate the efficacy of VR in the treatment of chronic neck pain in patients with FM. Material and methods: Single-blind randomized clinical trial study. Patients with FM who meet the inclusion criteria will be recruited and will be distributed into three groups (GC, G1, G2). G1 (VR + cervical mobility exercises), G2 (cervical mobility exercises), control group (CG). The treatment will be administered twice a week for 4 weeks. Measurements of variables such as FIQ, EQ-5D, kinesiophobia, pain (VAS and algometer), range of motion (ROM), fatigue and adherence to treatment will be performed.

A follow-up is intended to be carried out 15 days and a month after the end of the study.

Detailed Description

RESEARCH QUESTIONS: Can virtual reality combined with exercise improve the quality of life and impact of fibromyalgia? Can exercise performed with VR improve kinesiophobia, cervical range of motion, and pain? Will VR lead to improvements in patients' exercise functional capacity?

The aim is to collect a sample of more than 50 patients with fibromyalgia and cervical pain lasting more than three months. Variables to be collected include cervical range of motion (measured with goniometry), pain (measured with a visual analog scale and pressure algometry at two cervical points), kinesiophobia (TSK questionnaire), impact of fibromyalgia (FIQ), quality of life (EQ-5D), fatigue (BORG visual scale), disability caused by cervical pain (questionnaire), central sensitization (questionnaire), and functional capacity (measured with the "timed-up and go" physical test).

Recruitment was conducted through the Fibromyalgia and Chronic Pain Association of Mostoles. A one-month treatment will be administered with two sessions per week (with at least one day in between), totaling 8 sessions lasting approximately 30 to 40 minutes each. Measurements will be taken before starting the treatment, at the end of the treatment, 15 days after completion, and 30 days after completing the entire treatment.

Subjects will be randomized into three groups: a control group (CG) that will not receive treatment, Group 1 (G1) that will receive cervical mobility exercise combined with exercise using virtual reality (VR), and Group 2 (G2) that will receive cervical mobility exercise alone.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

This group will perform cervical mobility exercises and exercises with virtual reality glasses. 2 sessions will be held per week with a total of 8 sessions

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

This is a game set in space in which you pilot a spaceship and have to go through rings while dodging meteorites, all controlled by neck movements. Before starting the game, the assigned therapist is in charge of establishing the necessary movement parameters. In addition, the software allows you to modify the difficulty of the game. We will start the first 3 sessions in "easy" mode, where cervical mobility does not exceed 30º. The following 3 sessions will be configured in "medium" mode, reaching 60º of mobility. In the last 2 sessions, we will select the "hard" mode, which not only increases the speed of the spacecraft but also covers the entire range of cervical mobility.

Group 2

This group will only perform cervical mobility exercises at two sessions per week with a total of 8 sessions.

Group Type: ACTIVE_COMPARATOR

Exercises

Intervention Type: OTHER

The patients perform mobility and strengthening exercises for the cervical region, in which they are required to complete 1 set of 10 repetitions for each exercise. The patient should rest for at least 30 seconds between exercises.

Control group

This group will not receive any treatment or perform any type of exercise during the duration of this study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality

This is a game set in space in which you pilot a spaceship and have to go through rings while dodging meteorites, all controlled by neck movements. Before starting the game, the assigned therapist is in charge of establishing the necessary movement parameters. In addition, the software allows you to modify the difficulty of the game. We will start the first 3 sessions in "easy" mode, where cervical mobility does not exceed 30º. The following 3 sessions will be configured in "medium" mode, reaching 60º of mobility. In the last 2 sessions, we will select the "hard" mode, which not only increases the speed of the spacecraft but also covers the entire range of cervical mobility.

Intervention Type: OTHER

Exercises

The patients perform mobility and strengthening exercises for the cervical region, in which they are required to complete 1 set of 10 repetitions for each exercise. The patient should rest for at least 30 seconds between exercises.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Fibromyalgia condition
• present neck pain during the last 3 months

Exclusion Criteria

• present any pathology that contraindicates the use of virtual reality
• being pregnant at the moment of the study.
• not accepting the informed consent.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Camilo Jose Cela University

OTHER

Sponsor Role: lead

Responsible Party

Edurne Úbeda D'Ocasar

Doctor Edurne Úbeda D'Ocasar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edurne Ú Úbeda Docasar, Doctor

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

University Camilo José Cela

Madrid, , Spain

Countries

Spain

Other Identifiers

CamiloJcURVFM

Identifier Type: -

Identifier Source: org_study_id