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Immersive Virtual Reality for Pain-related Movement Dysfunctions in Patients With Chronic Shoulder Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05639764
Recruitment Status : Not yet recruiting
First Posted : December 6, 2022
Last Update Posted : December 6, 2022
Sponsor:
Information provided by (Responsible Party):
Alejandro Luque-Suarez, University of Malaga

Brief Summary:

The goal of this clinical trial is to the use of VRi specified effects on pain, kinesiophobia, fear of pain, disability, self-efficacy, grip strength and range of motion in motion in people with chronic shoulder pain. The main question[s] it aims to answer are:

  • Can specific immersive virtual reality software decrease movement-evoked pain in patients with chronic shoulder pain compared to non-specific software?
  • Can specific immersive virtual reality software increase shoulder flexion range of motion in patients with chronic shoulder pain compared to non-specific software? Participants will use a specific VRi software compared with non-specific VRi software

Condition or disease Intervention/treatment Phase
Shoulder Pain Virtual Reality Movement Disorders Device: Oculus Quest 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immersive Virtual Reality for Pain-related Movement Dysfunctions in Patients With Chronic Shoulder Pain: Randomized Clinical Trial (RCT)
Estimated Study Start Date : April 3, 2023
Estimated Primary Completion Date : July 3, 2023
Estimated Study Completion Date : July 3, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: specific Immersive virtual reality (VRi) software

Intervention group will perform active treatment using Virtual Reality software based on pain education and gamified exercise for gradual exposure to shoulder movement. The game involves visual stimuli and shoulder movement exercises in the shoulder flexion and abduction ranges in real time using immersive glasses located on the head and two controls on both hands. Patients will inhabit an avatar from an egocentric perspective.

The intervention will last 3 sessions / week of 15 minutes, therefore carrying a total duration of two weeks of treatment. Within the intervention will consist of a pill of education in pain neuroscience (PNE) of 1 minute duration, followed by an exposure level that will last 2:30 minutes where a progression will be made in number of ranges of motion and speed. Each session will consist of 2 intervention blocks (PNE + Gradual Exposure pill). The content of the PNE educational pills have been selected according to the objective of the study.

Device: Oculus Quest 2
A specific immersive virtual reality software designed to address chronic shoulder pain on the Oculus Quest 2 device.
Other Name: specific Immersive virtual reality (VRi) software

Active Comparator: non specific Immersive virtual reality (VRi) software
The control group will perform a VRi intervention with the game "Tsuro", which consists of a puzzle-based strategy game where the patient will have to solve a maze by placing pieces. This intervention will attempt to assess the influence of the immersive context and the playful component compared to the intervention group. This treatment will last 3 sessions / week of 15 minutes, therefore taking a total duration of two weeks of treatment with a total of 6 sessions.
Device: Oculus Quest 2
a VRi placebo intervention with the game "Tsuro", which consists of a puzzle-based strategy game where the patient will have to solve a maze by placing pieces.
Other Name: non specific Immersive virtual reality (VRi) software




Primary Outcome Measures :
  1. Pain during shoulder flexion movement [ Time Frame: Change from baseline before the intervention and after the intervention up to 1 week ]
    Visual Analogue Pain Scale: Score from 0 to 10


Secondary Outcome Measures :
  1. Range of movement in flexion of the shoulder [ Time Frame: Change from baseline before the intervention and after the intervention up to 1 week ]
    Digital Goniometry: scores from 0-180 grades

  2. Hand grip strength [ Time Frame: Change from baseline before the intervention and after the intervention up to 1 week ]
    Digital dynamometry: scores from 0-1000 Newton

  3. Self-efficacy [ Time Frame: Change from baseline before the intervention and after the intervention up to 1 week ]
    Self-efficacy questionnaire in chronic pain: Score from 0 to 190

  4. Disability [ Time Frame: Change from baseline before the intervention and after the intervention up to 1 week ]
    Questionnaire shoulder and pain disability index (SPADI-sp): Score from 0 to 130

  5. Kinesiophobia [ Time Frame: Change from baseline before the intervention and after the intervention up to 1 week ]
    Tampa Questionnaire for Kinesiophobia (TSK-11): Score from 11 to 44

  6. Fear of pain [ Time Frame: Change from baseline before the intervention and after the intervention up to 1 week ]
    Pain fear questionnaire (FPQ-III): Score 0-150

  7. Age [ Time Frame: Change from baseline before the intervention and after the intervention up to 1 week ]
    Self-developed questionnaire

  8. Sex [ Time Frame: Baseline ]
    Self-developed questionnaire

  9. Profession [ Time Frame: Baseline ]
    Self-developed questionnaire

  10. Marital status [ Time Frame: Baseline ]
    Self-developed questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • People from 18 to 65 years old
  • Shoulder pain of at least three months of evolution located in the proximal anterolateral region of the shoulder
  • Presenting shoulder pain during movements with a history of traumatic or insidious onset
  • Agree to participate in the study and sign the informed consent

Exclusion Criteria:

  • Shoulder pain resulting from cervical spine dysfunction
  • Cognitive deficits
  • Uso of medications for pain control in the previous 24 hours
  • A history of neurological or psychiatric disorders
  • Adhesive capsulitis syndrome (limited passive range of motion of the shoulder: external rotation < 30°; elevation < 150°)
  • Patients with shoulder instability
  • Previous surgery of the shoulder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05639764


Contacts
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Contact: Guerra-Armas Javier, MsC 34661640727 javi.guerra.armas@gmail.com
Contact: Luque-Suarez Alejandro, PhD 34606939920 aluques@uma.es

Locations
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Spain
Unidad Docente Asistencial Fisioterapia
Málaga, Spain, 29071
Contact: Luque-Suarez Alejandro, PhD    606939920    aluques@uma.es   
Sponsors and Collaborators
University of Malaga
Publications:

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Responsible Party: Alejandro Luque-Suarez, Head of Physiotherapy Departament, University of Malaga
ClinicalTrials.gov Identifier: NCT05639764    
Other Study ID Numbers: UMalagaShoulder
First Posted: December 6, 2022    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shoulder Pain
Movement Disorders
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Central Nervous System Diseases
Nervous System Diseases