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

NCT05933941 | Completed

• 1 other identifier: CamiloJcURVFM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

virtual reality; chronic pain; exercises; fibromyalgia

Outcome Measures

Primary Outcomes (3)

• Pain (VAS)

  visual analogic scale. the maximum value will be 10 and the minimum value will be 0. The higher the score, the more pain the patient will have.

  base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.

• Pain (algometry)

  Algometer. the maximum value will be 5 and the minimum value will be 0. The higher the score, the less pain the patient will have.

  base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment.

• Pain (NDI)

  Neck Disability Index. Score from 0 to 50. The higher the score, the greater the disability.

  base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment.

Secondary Outcomes (7)

• Fatigue (BORG)

  base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.

• Range Of Movement (goniometry)

  base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment.

• Fibromyalgia Impact (FIQ)

  base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.

• Quality of life (EQ-5D)

  base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.

• Central Sensibilization (CSI)

  base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.

Study Arms (3)

Group 1

EXPERIMENTAL

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

Other: Virtual reality

Group 2

ACTIVE COMPARATOR

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

Other: Exercises

Control group

NO INTERVENTION

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

Interventions

Virtual reality 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 1

Exercises 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.

Group 2

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Camilo Jose Cela University: lead

Study Sites (1)

University Camilo José Cela

Madrid, 28692, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Edurne Ú Úbeda Docasar, Doctor

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Edurne Úbeda D'Ocasar

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 6, 2023
• Study Start: April 1, 2024
• Primary Completion: September 4, 2024
• Study Completion: February 1, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)