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

• ClinicalTrials.gov Identifier: NCT05933941
• Recruitment Status: Not yet recruiting
• First Posted: July 6, 2023
• Sponsor: Camilo Jose Cela University
• Information provided by (Responsible Party): Edurne Úbeda D'Ocasar, Camilo Jose Cela University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Other: Virtual reality; Other: Exercises	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Virtual Reality as a Treatment Tool for Chronic Neck Pain in Patients With Fibromyalgia
• Estimated Study Start Date: May 30, 2024
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: June 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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.
Active Comparator: Group 2; This group will only perform cervical mobility exercises at two sessions per week with a total of 8 sessions.	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.
No Intervention: Control group; This group will not receive any treatment or perform any type of exercise during the duration of this study.

Outcome Measures

Primary Outcome Measures :

1. Pain (VAS) [ Time Frame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment. ]
   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.
2. Pain (algometry) [ Time Frame: base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment. ]
   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.
3. Pain (NDI) [ Time Frame: base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment. ]
   Neck Disability Index. Score from 0 to 50. The higher the score, the greater the disability.

Secondary Outcome Measures :

1. Fatigue (BORG) [ Time Frame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment. ]
   Visual Scale BORG. Score from 0 to 10. The higher the score, the greater the perception of fatigue.
2. Range Of Movement (goniometry) [ Time Frame: base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment. ]
   Goniometry of the upper trapezius and suboccipital muscles. Score from 0 to 360º. The higher the degree, the greater the mobility of the patient
3. Fibromyalgia Impact (FIQ) [ Time Frame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment. ]
   Fibromyalgia Impact Questionnaire. The higher the score obtained, the greater the impact of fibromyalgia on the patient.
4. Quality of life (EQ-5D) [ Time Frame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment. ]
   EQ-5D Questionnaire. Score from 0 to 15. The higher the score, the worse the quality of life
5. Central Sensibilization (CSI) [ Time Frame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment. ]
   Central Sensibiliztion Questionnaire. the result obtained ranges from 0 to 100 and the higher the value obtained from the questionnaire the greater the degree of awareness
6. kinesiophobia (TSK) [ Time Frame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment. ]

   TSK Questionnaire. Each item is scored on a 4-point Likert scale (1 to 4). The response format and numerical values are as follows: (1) strongly agree, (2) disagree, (3) agree, and (4) strongly agree.

   (2) disagree, (3) agree, and (4) strongly agree. The scoring of items 4, 8, 12 and 16 must be inverted to calculate the final score, which can range from 17 to 68.

   17 and 68 and which is obtained by adding the values of the different items.

7. functional capacity (timed-up and go) [ Time Frame: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment. ]

   exercise test (timed-up and go).If the patient takes less than 10 seconds to perform the test, the patient is considered to be at low risk of falling.

   considered low risk of falling. Between 10 and 20 seconds: indicates fragility (risk of falling).

   risk of falling). More than 20 seconds: High risk of falling.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Edurne Ú Docasar; +34918153131 ext 19217; eubeda@ucjc.edu

Sponsors and Collaborators

Camilo Jose Cela University

Investigators

• Principal Investigator: Edurne Ú Docasar; Associate Professor

More Information

• Responsible Party: Edurne Úbeda D'Ocasar, Doctor Edurne Úbeda D'Ocasar, Camilo Jose Cela University
• ClinicalTrials.gov Identifier: NCT05933941
• Other Study ID Numbers: CamiloJcURVFM
• First Posted: July 6, 2023
• Last Update Posted: May 14, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Edurne Úbeda D'Ocasar, Camilo Jose Cela University:

virtual reality; chronic pain; exercises; fibromyalgia

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Neck Pain; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations