Shoulder Pain Clinical Trial
Official title:
Immersive Virtual Reality for Pain-related Movement Dysfunctions in Patients With Chronic Shoulder Pain: Randomized Clinical Trial (RCT)
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
Status | Not yet recruiting |
Enrollment | 66 |
Est. completion date | July 3, 2023 |
Est. primary completion date | July 3, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Unidad Docente Asistencial Fisioterapia | Málaga |
Lead Sponsor | Collaborator |
---|---|
University of Malaga |
Spain,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Range of movement in flexion of the shoulder | Digital Goniometry: scores from 0-180 grades | Change from baseline before the intervention and after the intervention up to 1 week | |
Secondary | Hand grip strength | Digital dynamometry: scores from 0-1000 Newton | Change from baseline before the intervention and after the intervention up to 1 week | |
Secondary | Self-efficacy | Self-efficacy questionnaire in chronic pain: Score from 0 to 190 | Change from baseline before the intervention and after the intervention up to 1 week | |
Secondary | Disability | Questionnaire shoulder and pain disability index (SPADI-sp): Score from 0 to 130 | Change from baseline before the intervention and after the intervention up to 1 week | |
Secondary | Kinesiophobia | Tampa Questionnaire for Kinesiophobia (TSK-11): Score from 11 to 44 | Change from baseline before the intervention and after the intervention up to 1 week | |
Secondary | Fear of pain | Pain fear questionnaire (FPQ-III): Score 0-150 | Change from baseline before the intervention and after the intervention up to 1 week | |
Secondary | Age | Self-developed questionnaire | Change from baseline before the intervention and after the intervention up to 1 week | |
Secondary | Sex | Self-developed questionnaire | Baseline | |
Secondary | Profession | Self-developed questionnaire | Baseline | |
Secondary | Marital status | Self-developed questionnaire | Baseline |
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