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

NCT05639764 | Unknown

• 1 other identifier: UMalagaShoulder
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Shoulder Pain; Virtual Reality; Movement Disorders

Outcome Measures

Primary Outcomes (1)

• Pain during shoulder flexion movement

  Visual Analogue Pain Scale: Score from 0 to 10

  Change from baseline before the intervention and after the intervention up to 1 week

Secondary Outcomes (10)

• Range of movement in flexion of the shoulder

  Change from baseline before the intervention and after the intervention up to 1 week

• Hand grip strength

  Change from baseline before the intervention and after the intervention up to 1 week

• Self-efficacy

  Change from baseline before the intervention and after the intervention up to 1 week

• Disability

  Change from baseline before the intervention and after the intervention up to 1 week

• Kinesiophobia

  Change from baseline before the intervention and after the intervention up to 1 week

Study Arms (2)

specific Immersive virtual reality (VRi) software

EXPERIMENTAL

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

non specific Immersive virtual reality (VRi) software

ACTIVE COMPARATOR

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

Interventions

Oculus Quest 2 DEVICE

A specific immersive virtual reality software designed to address chronic shoulder pain on the Oculus Quest 2 device.

Also known as: specific Immersive virtual reality (VRi) software

specific Immersive virtual reality (VRi) software

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Unidad Docente Asistencial Fisioterapia

Málaga, 29071, Spain

Location

Related Publications (8)

• Page MJ, O'Connor DA, Malek M, Haas R, Beaton D, Huang H, Ramiro S, Richards P, Voshaar MJH, Shea B, Verhagen AP, Whittle SL, van der Windt DA, Gagnier JJ, Buchbinder R; OMERACT Shoulder Core Set Working Group. Patients' experience of shoulder disorders: a systematic review of qualitative studies for the OMERACT Shoulder Core Domain Set. Rheumatology (Oxford). 2019 Mar 6:kez046. doi: 10.1093/rheumatology/kez046. Online ahead of print.

  PMID: 30843587 BACKGROUND

• Meehan K, Wassinger C, Roy JS, Sole G. Seven Key Themes in Physical Therapy Advice for Patients Living With Subacromial Shoulder Pain: A Scoping Review. J Orthop Sports Phys Ther. 2020 Jun;50(6):285-a12. doi: 10.2519/jospt.2020.9152.

  PMID: 32476583 BACKGROUND

• Farzad M, MacDermid JC, Ring DC, Shafiee E. A Scoping Review of the Evidence regarding Assessment and Management of Psychological Features of Shoulder Pain. Rehabil Res Pract. 2021 Sep 30;2021:7211201. doi: 10.1155/2021/7211201. eCollection 2021.

  PMID: 34631168 BACKGROUND

• Martinez-Calderon J, Meeus M, Struyf F, Miguel Morales-Asencio J, Gijon-Nogueron G, Luque-Suarez A. The role of psychological factors in the perpetuation of pain intensity and disability in people with chronic shoulder pain: a systematic review. BMJ Open. 2018 Apr 13;8(4):e020703. doi: 10.1136/bmjopen-2017-020703.

  PMID: 29654040 BACKGROUND

• Alaiti RK, Caneiro JP, Gasparin JT, Chaves TC, Malavolta EA, Gracitelli MEC, Meulders A, da Costa MF. Shoulder pain across more movements is not related to more rotator cuff tendon findings in people with chronic shoulder pain diagnosed with subacromial pain syndrome. Pain Rep. 2021 Dec 16;6(4):e980. doi: 10.1097/PR9.0000000000000980. eCollection 2021 Nov-Dec.

  PMID: 34938935 BACKGROUND

• Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.

  PMID: 31308733 BACKGROUND

• Matamala-Gomez M, Donegan T, Bottiroli S, Sandrini G, Sanchez-Vives MV, Tassorelli C. Immersive Virtual Reality and Virtual Embodiment for Pain Relief. Front Hum Neurosci. 2019 Aug 21;13:279. doi: 10.3389/fnhum.2019.00279. eCollection 2019.

  PMID: 31551731 BACKGROUND

• Lin I, Wiles L, Waller R, Goucke R, Nagree Y, Gibberd M, Straker L, Maher CG, O'Sullivan PPB. What does best practice care for musculoskeletal pain look like? Eleven consistent recommendations from high-quality clinical practice guidelines: systematic review. Br J Sports Med. 2020 Jan;54(2):79-86. doi: 10.1136/bjsports-2018-099878. Epub 2019 Mar 2.

  PMID: 30826805 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Movement Disorders

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Guerra-Armas Javier, MsC

CONTACT

34661640727; javi.guerra.armas@gmail.com

Luque-Suarez Alejandro, PhD

CONTACT

34606939920; aluques@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physiotherapy Departament

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 6, 2022
• Study Start: April 3, 2023
• Primary Completion: July 3, 2023
• Study Completion: July 3, 2023
• Last Updated: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)