FibromyalgiaVRTCNPPFMNCT05933941
Virtual Reality as a Treatment Tool for Chronic Neck Pain in Patients With Fibromyalgia
A study testing Virtual reality and Exercises in people with Fibromyalgia, run by Camilo Jose Cela University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Virtual reality and Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibromyalgia condition
- present neck pain during the last 3 months
Who cannot join
- present any pathology that contraindicates the use of virtual reality
- being pregnant at the moment of the study.
- not accepting the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Virtual reality, Exercises
- Keywords
- virtual reality, chronic pain, exercises, fibromyalgia
- Medical subject headings
- Fibromyalgia, Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
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.
ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Visual Scale BORG. Score from 0 to 10. The higher the score, the greater the perception of fatigue.
Measured: 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)
Goniometry of the upper trapezius and suboccipital muscles. Score from 0 to 360º. The higher the degree, the greater the mobility of the patient
Measured: base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment.
Fibromyalgia Impact (FIQ)
Fibromyalgia Impact Questionnaire. The higher the score obtained, the greater the impact of fibromyalgia on the patient.
Measured: 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)
EQ-5D Questionnaire. Score from 0 to 15. The higher the score, the worse the quality of life
Measured: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
Central Sensibilization (CSI)
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
Measured: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
kinesiophobia (TSK)
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.
Measured: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
functional capacity (timed-up and go)
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.
Measured: base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Apr 2024
- Primary completion4 Sep 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edurne Úbeda D'Ocasar, Camilo Jose Cela University
- Investigators
- Edurne Ú Úbeda Docasar, Doctor, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933941
- Sponsor's protocol ID
- CamiloJcURVFM
- Acronym
- VRTCNPPFM
- Status last verified
- Feb 2025
- First submitted
- 19 Jun 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Treatment Tool for Chronic Neck Pain in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT05933941
- Acronym / sponsor ID
- VRTCNPPFM / CamiloJcURVFM
- Conditions
- Fibromyalgia
- Keywords
- virtual reality, chronic pain, exercises, fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Virtual realityThis 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 2 | Active comparator | Other: ExercisesThis group will only perform cervical mobility exercises at two sessions per week with a total of 8 sessions. |
| Control group | No intervention | –This group will not receive any treatment or perform any type of exercise during the duration of this study. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fibromyalgia condition
- present neck pain during the last 3 months
Key exclusion criteria (3 listed)
- present any pathology that contraindicates the use of virtual reality
- being pregnant at the moment of the study.
- not accepting the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityThis 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 | Group 1 |
| ExercisesThe 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. | Other | Group 2 |
Primary outcome
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.
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.
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.
7 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edurne Ú Úbeda Docasar, Doctor principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and Exercises in people with Fibromyalgia, run by Camilo Jose Cela University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.