Effectiveness of Immersive Virtual Reality on Clinical Variables, Clinimetric Measurements, and Biomarkers in Patients With Persistent Shoulder Pain: A Randomized Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
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.
详细描述
Shoulder pain represents the third most common cause of musculoskeletal pain and the leading cause of non-traumatic upper limb pain. This condition holds significant musculoskeletal relevance, as up to 66.7% of individuals experience shoulder pain at least once in their lifetime, and symptoms persist beyond 18 months in 50% of cases, impacting daily activities at home and in the workplace. Furthermore, shoulder pain can disrupt sleep patterns and contribute to work-related challenges, such as sick leave, early retirement, or job loss. Persistent shoulder pain also imposes significant socioeconomic costs, estimated at $7 billion in the United States in 2000 and exceeding €1.5 million between 2004 and 2007 in the Canary Islands, Spain.
Physiotherapy has emerged as a promising approach for managing this condition. In Sweden, patients receiving physiotherapy as a first-line treatment generated lower total healthcare costs. Similarly, in the United States, musculoskeletal patients who initiated care with physiotherapy achieved better cost-effectiveness, required fewer sessions, and experienced greater functional recovery.
Diagnosing shoulder pain accurately remains challenging for clinicians, primarily due to inconsistencies and a lack of uniformity in diagnostic nomenclature and criteria. Consequently, diagnosis may need to rely on sub-classifications of patients with reliably reproducible characteristics. In this context, rotator cuff-related shoulder pain is consistently reported as the most prevalent diagnosis in individuals with shoulder pain.
Patients with rotator cuff-related shoulder pain often report moderate-to-severe pain intensity, limitations in daily activities, reduced range of motion, and/or loss of strength. Persistent pain in this condition is also commonly associated with psychosocial factors, such as fear of movement, pain hypervigilance, and/or loss of self-efficacy-barriers that can hinder recovery. Collectively, these factors significantly affect patients' quality of life.
A novel aspect of this project is the proposed examination of biomarkers associated with systemic inflammation and chronic pain in this clinical population, specifically C-reactive protein (CRP) and calcitonin gene-related peptide (CGRP). C-reactive protein is a marker of systemic inflammation, with elevated levels linked to various chronic pain conditions, suggesting an inflammatory component that may modulate pain perception and intensity in these patients. Meanwhile, CGRP is a neuropeptide involved in nociceptive signal transmission and inflammatory response modulation. Elevated CGRP levels have been documented in several chronic pain conditions, including osteoarthritis, migraines, and joint disorders, where peripheral and central sensitization processes are present.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
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
干预措施: Exercise (Procedure)
Experimental group
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
干预措施: Immersive Virtual Reality (Device)
Experimental group
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
干预措施: Exercise (Procedure)
结局指标
主要结局
Pain
时间窗: Baseline, 1, 2 and 3 months follow-up
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).
Shoulder disability
时间窗: Baseline, 1, 2 and 3 months follow-up
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.
Shoulder external rotation strength
时间窗: Baseline, 1, 2 and 3 months follow-up
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).
Handgrip strength
时间窗: Baseline, 1, 2 and 3 months follow-up
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).
Shoulder mobility
时间窗: Baseline, 1, 2 and 3 months follow-up
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).
Pain Intensity
时间窗: Baseline, 1, 2 and 3 months follow-up
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).
次要结局
- Daily Activity Avoidance Behaviors(Baseline, 1, 2 and 3 months follow-up)
- Pain hypervigilance(Baseline, 1, 2 and 3 months follow-up)
- Self efficacy(Baseline, 1, 2 and 3 months follow-up)
- Motor and functional deficits related to pain(Baseline, 1, 2 and 3 months follow-up)
- Biomarkers(Baseline, 1 and 3 months follow-up)
- Quality of life(Baseline, 1, 2 and 3 months follow-up)
- Kinesiophobia(Baseline, 1, 2 and 3 months follow-up)
- Implicit motor imagery performance(Baseline, 1, 2 and 3 months follow-up)
- Sleep quality(Baseline, 1, 2 and 3 months follow-up)
- Self-reported quality of life(Baseline, 1, 2 and 3 months follow-up)
研究者
Alberto Roldán
PhD
Universidad Francisco de Vitoria