NCT05933941

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Camilo Jose Cela University · Academic / Other
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-09-04
• Completion: 2025-02-01
• First posted: 2023-07-06
• Last updated: 2025-02-14

Locations

1 site across 1 country: Spain