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

Primary Purpose

Fibromyalgia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual reality
Exercises
Sponsored by
Camilo Jose Cela University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring virtual reality, chronic pain, exercises, fibromyalgia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Group 1

    Group 2

    Control group

    Arm Description

    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

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Fatigue (BORG)
    Visual Scale BORG. Score from 0 to 10. The higher the score, the greater the perception of fatigue.
    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
    Fibromyalgia Impact (FIQ)
    Fibromyalgia Impact Questionnaire. The higher the score obtained, the greater the impact of fibromyalgia on the patient.
    Quality of life (EQ-5D)
    EQ-5D Questionnaire. Score from 0 to 15. The higher the score, the worse the quality of life
    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
    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.
    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.

    Full Information

    First Posted
    June 19, 2023
    Last Updated
    October 19, 2023
    Sponsor
    Camilo Jose Cela University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05933941
    Brief Title
    Virtual Reality as a Treatment Tool for Chronic Neck Pain in Patients With Fibromyalgia
    Acronym
    VRTCNPPFM
    Official Title
    Virtual Reality as a Treatment Tool for Chronic Neck Pain in Patients With Fibromyalgia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 30, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    January 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Camilo Jose Cela University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia
    Keywords
    virtual reality, chronic pain, exercises, fibromyalgia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    This group will only perform cervical mobility exercises at two sessions per week with a total of 8 sessions.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    This group will not receive any treatment or perform any type of exercise during the duration of this study.
    Intervention Type
    Other
    Intervention Name(s)
    Virtual reality
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Exercises
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pain (VAS)
    Description
    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.
    Time Frame
    base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
    Title
    Pain (algometry)
    Description
    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.
    Time Frame
    base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment.
    Title
    Pain (NDI)
    Description
    Neck Disability Index. Score from 0 to 50. The higher the score, the greater the disability.
    Time Frame
    base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment.
    Secondary Outcome Measure Information:
    Title
    Fatigue (BORG)
    Description
    Visual Scale BORG. Score from 0 to 10. The higher the score, the greater the perception of fatigue.
    Time Frame
    base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
    Title
    Range Of Movement (goniometry)
    Description
    Goniometry of the upper trapezius and suboccipital muscles. Score from 0 to 360º. The higher the degree, the greater the mobility of the patient
    Time Frame
    base line; after finishing the treatment (one moth), 15 days after finishing the treatment and 30 days after finishing the treatment.
    Title
    Fibromyalgia Impact (FIQ)
    Description
    Fibromyalgia Impact Questionnaire. The higher the score obtained, the greater the impact of fibromyalgia on the patient.
    Time Frame
    base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
    Title
    Quality of life (EQ-5D)
    Description
    EQ-5D Questionnaire. Score from 0 to 15. The higher the score, the worse the quality of life
    Time Frame
    base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
    Title
    Central Sensibilization (CSI)
    Description
    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
    Time Frame
    base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
    Title
    kinesiophobia (TSK)
    Description
    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.
    Time Frame
    base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.
    Title
    functional capacity (timed-up and go)
    Description
    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.
    Time Frame
    base line; after finishing the treatment (one month), 15 days after finishing the treatment and 30 days after finishing the treatment.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Edurne Ú Docasar
    Phone
    +34918153131
    Ext
    19217
    Email
    eubeda@ucjc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edurne Ú Docasar
    Organizational Affiliation
    Associate Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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