Clinical trial NCT05933941: Virtual Reality as a Treatment Tool for Chronic Neck Pain in Patients With Fibromyalgia
Official title: Virtual Reality as a Treatment Tool for Chronic Neck Pain in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: virtual reality
chronic pain
exercises
fibromyalgia
Lead sponsor: Camilo Jose Cela University
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain (VAS)
timeFrame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
measure: Pain (algometry)
timeFrame: base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment.
measure: Pain (NDI)
timeFrame: base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment.
Secondary outcomes:
measure: Fatigue (BORG)
timeFrame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
measure: Range Of Movement (goniometry)
timeFrame: base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment.
measure: Fibromyalgia Impact (FIQ)
timeFrame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
measure: Quality of life (EQ-5D)
timeFrame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
measure: Central Sensibilization (CSI)
timeFrame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
measure: kinesiophobia (TSK)
timeFrame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
measure: functional capacity (timed-up and go)
timeFrame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: University Camilo José Cela
Study officials:
affiliation: Associate Professor
name: Edurne Ú Úbeda Docasar, Doctor
role: PRINCIPAL_INVESTIGATOR
References: