NCT06795464

Brief Summary

Shoulder pain is one of the primary reasons for seeking physiotherapy care. The high prevalence of rotator cuff-related shoulder pain underscores the need for research into novel treatment approaches that may enhance the clinical outcomes of conventional physiotherapy interventions. Immersive Virtual Reality (IVR) has been demonstrated to serve as an effective adjunct for pain management by providing distraction and altering patients' pain perception. Specifically, when used alongside exercise, IVR has been shown to induce hypoalgesia in individuals with chronic low back pain. Additionally, IVR is emerging as a promising tool to enhance motivation and improve adherence to rehabilitation protocols, which is critical for long-term treatment implementation and achieving positive outcomes. These findings suggest that virtual reality may provide an innovative approach to managing pain in patients with rotator cuff-related shoulder pain, improving their pain experience, functionality, and quality of life. To date, no study has directly compared the effectiveness of combining IVR with standard physiotherapy treatments versus standard treatments alone on clinical variables, clinimetric measures, and biomarkers in individuals with persistent shoulder pain related to the rotator cuff. Therefore, conducting a randomized multicenter clinical trial on this subject, facilitated by international collaboration among RIU-affiliated universities, could provide a robust foundation for implementing new technologies such as virtual reality in pain management and advancing rehabilitation strategies. The objective of this project is as follows: To compare the effectiveness of combining immersive virtual reality with standard physiotherapy treatment versus standard treatment alone on clinical variables, clinimetric measures, and biomarkers in individuals with persistent rotator cuff-related shoulder pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2026

Completed
Last Updated

May 4, 2026

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

January 21, 2025

Last Update Submit

April 28, 2026

Conditions

Shoulder Pain

Keywords

shoulder painvirtual realityexerciserandomized clinical trialchronic pain

Outcome Measures

Primary Outcomes (5)

  • Pain Intensity

    Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), a visual 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).

    Baseline, 1, 2 and 3 months follow-up

  • Shoulder disability

    Self-reported shoulder function will be evaluated using the Spanish version of the Shoulder Pain And Disability Index (SPADI). This questionnaire, originally developed to assess shoulder pain and disability through 13 items (Williams et al., 1995), has been described as a tool capable of effectively discriminating between patients with improving or worsening conditions (Roy et al., 2009). Following a transcultural adaptation, the Spanish version (Membrilla-Mesa et al., 2015) retains the 13 items, assessing pain and disability in shoulder dysfunction. This patient-reported outcome measure is suitable for both clinical practice and research.

    Baseline, 1, 2 and 3 months follow-up

  • Shoulder external rotation strength

    Isometric shoulder strength in external rotation will be measured using a MicroFET 2 MT Digital Handheld Dynamometer (Hoggan Health Industries, West Draper, UT). Handheld dynamometry has demonstrated good-to-excellent intra-examiner reliability for measuring isometric shoulder strength (Intraclass Correlation Coefficient = 0.87-0.99) (McLaine et al., 2016; Holt et al., 2016).

    Baseline, 1, 2 and 3 months follow-up

  • Handgrip strength

    Handgrip strength will be assessed using a Jamar Hand Dynamometer (Sammons Preston Rolyan, Bolingbrook, IL). This device has shown good-to-excellent intra-examiner reliability for measuring isometric handgrip strength (Intraclass Correlation Coefficient = 0.85-0.98) (Roberts et al., 2011).

    Baseline, 1, 2 and 3 months follow-up

  • Shoulder mobility

    Shoulder mobility will be assessed during movements of flexion, abduction, external rotation at 0° abduction, external rotation at 90° abduction, and internal rotation at 90° abduction. Measurements will be conducted using a smartphone application-based inclinometer (Plaincode Software Solutions, Gunzenhausen, Germany), which has been validated with excellent inter-examiner reliability and validity in symptomatic individuals (Intraclass Correlation Coefficient \> 0.80) (Werner et al., 2014).

    Baseline, 1, 2 and 3 months follow-up

Secondary Outcomes (9)

  • Biomarkers

    Baseline, 1 and 3 months follow-up

  • Self-reported quality of life

    Baseline, 1, 2 and 3 months follow-up

  • Kinesiophobia

    Baseline, 1, 2 and 3 months follow-up

  • Daily Activity Avoidance Behaviors

    Baseline, 1, 2 and 3 months follow-up

  • Pain hypervigilance

    Baseline, 1, 2 and 3 months follow-up

  • +4 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Participants assigned to the control group will receive standard treatment for rotator cuff-related shoulder pain. This will consist of standardized therapeutic exercise performed for 25 minutes, 3 times per week, over a 12-week period. The exercise regimen will be individualized based on intensity, utilizing the Rate of Perceived Exertion (RPE) scale, with the goal of achieving intensity levels of 6-8 on a scale of 0 to 10

Procedure: Exercise

Experimental group

EXPERIMENTAL

Participants in the experimental group will follow a treatment program that combines standard care with an immersive virtual reality (IVR) intervention. During the first 4 weeks, participants will undergo the IVR intervention, followed by the same standard treatment as the control group for the subsequent 8 weeks. IVR Intervention Protocol: Sessions and Equipment: Participants will attend up to 12 IVR sessions using a head-mounted device (HMD), the Meta Quest III, equipped with a hand-tracking system (Meta VR, Facebook, California) to enable interaction with the therapeutic software Dynamics PainRehab (Dynamics VR Rehab, Seville, Spain). The Meta Quest III HMD is chosen for its commercial availability, widespread use, minimal visual latency, and user-friendly interface. The software application, "Hombro PainRehab," features multisensory inputs (vision and sound), high-quality graphics, head and hand tracking, and provides a highly immersive experience. The IVR intervention incorporat

Device: Immersive Virtual RealityProcedure: Exercise

Interventions

Immersive Virtual RealityDEVICE

Participants in the experimental group will follow a treatment program that combines standard care with an immersive virtual reality (IVR) intervention. During the first 4 weeks, participants will undergo the IVR intervention, followed by the same standard treatment as the control group for the subsequent 8 weeks. IVR Intervention Protocol: Sessions and Equipment: Participants will attend up to 12 IVR sessions using a head-mounted device (HMD), the Meta Quest III, equipped with a hand-tracking system (Meta VR, Facebook, California) to enable interaction with the therapeutic software Dynamics PainRehab (Dynamics VR Rehab, Seville, Spain). The Meta Quest III HMD is chosen for its commercial availability, widespread use, minimal visual latency, and user-friendly interface. The software application, "Hombro PainRehab," features multisensory inputs (vision and sound), high-quality graphics, head and hand tracking, and provides a highly immersive experience. The IVR intervention incorporate

Also known as: virtual reality
Experimental group
ExercisePROCEDURE

Participants assigned to the control group will receive standard treatment for rotator cuff-related shoulder pain. This will consist of standardized therapeutic exercise performed for 25 minutes, 3 times per week, over a 12-week period. The exercise regimen will be individualized based on intensity, utilizing the Rate of Perceived Exertion (RPE) scale, with the goal of achieving intensity levels of 6-8 on a scale of 0 to 10.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 70 years.
  • Shoulder pain persisting for at least six months.
  • Presence of shoulder pain during movement.
  • Clinical diagnosis of rotator cuff-related shoulder pain.
  • Willingness to participate in the study and signing of informed consent.

You may not qualify if:

  • Shoulder pain related to cervical spine conditions.
  • Presence of pain in the elbow, wrist, and/or hand.
  • Clinical diagnosis of frozen shoulder.
  • Clinical diagnosis of shoulder instability.
  • Cognitive impairments.
  • Concomitant physiotherapy treatments during the study period.
  • History of trauma associated with the onset of shoulder pain.
  • Previous fractures in the affected shoulder.
  • Prior surgeries in the affected shoulder.
  • Use of analgesic or anti-inflammatory medications within 24 hours prior to study participation.
  • Presence of rheumatic or neurological diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Francisco de Vitoria

Madrid, Madrid, 28223, Spain

Location

Related Publications (1)

  • Ahmadpour N, Randall H, Choksi H, Gao A, Vaughan C, Poronnik P. Virtual Reality interventions for acute and chronic pain management. Int J Biochem Cell Biol. 2019 Sep;114:105568. doi: 10.1016/j.biocel.2019.105568. Epub 2019 Jul 12.

    PMID: 31306747BACKGROUND

MeSH Terms

Conditions

Shoulder PainMotor ActivityChronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 28, 2025

Study Start

March 1, 2025

Primary Completion

April 28, 2026

Study Completion

April 28, 2026

Last Updated

May 4, 2026

Record last verified: 2025-01

Locations

ES(1)