Background Chronic musculoskeletal pain, especially chronic low back pain (CLBP), is the leading cause of disability worldwide, with a burden expected to rise due to aging and increased longevity. Despite strong evidence supporting multimodal and non-pharmacological management-particularly active physical therapy and self-management-clinical practice still shows low adherence to guidelines, with excessive reliance on imaging, rest, injections, and surgery.
Adherence to physical therapy remains one of the most significant barriers: only 40-50% of patients follow prescribed exercise programs. Factors include kinesiophobia, low motivation, and logistical obstacles. Mixed realities (XR: VR, AR, MR) offer solutions by enhancing motivation, reducing barriers, and personalizing rehabilitation. Evidence from systematic reviews shows VR-based rehabilitation can reduce pain, disability, and kinesiophobia, with immersive VR offering additional benefits like presence and habit-building.
The SHARESPACE project developed and tested a novel XR rehabilitation environment for CLBP that integrates immersive VR/AR, tele-rehabilitation, real-time motor tracking, avatars for social support, and cognitive architectures for synchronization. Usability studies with patients, clinicians, and the general population confirm its feasibility and acceptance. SHARESPACE has completed phases 1 and 2 of XR intervention development (design and feasibility), now aiming to move to phase 3: large-scale clinical validation.
Objectives The main goal is to evaluate not only short-term efficacy but long-term, as well as including more accurate and objective measures. A second objective is the commercial exploitation WE will valuate the efficacy, adherence, and cost-effectiveness of the SHARESPACE XR rehabilitation system compared to usual care in patients with CLBP.
Specific objectives include:
1. To conduct a two-site randomized controlled trial (RCT) comparing XR rehabilitation with conventional group rehabilitation. 2. To assess both short-term and long-term outcomes (pain intensity, disability, kinesiophobia). 3. To monitor and improve adherence through ecological momentary assessment and intervention (EMA/EMI) using an app and activity trackers. 4. To enhance motivation and engagement with gamification, social connectedness, and avatar-based interaction. 5. To generate evidence for commercial exploitation and integration into health systems.
Methodology
The project will conduct a two-site RCT with CLBP patients. Participants will be randomly allocated to:
* XR rehabilitation:
* Two hospital sessions (traditional + XR-assisted training). * Four remote XR sessions with therapist and patients (L1 avatars). * Continued home-based XR with automated therapist avatars (L3) for up to 120 days. * Integration of EMA/EMI via an app and wearable devices to monitor daily activity, sleep, and adherence, with automated prompts to encourage compliance. * Usual care: standard group rehabilitation sessions for 8 weeks.
Primary outcomes:
* Pain intensity (VAS, BPI). * Disability (Oswestry Disability Index). * Kinesiophobia (Tampa Scale of Kinesiophobia). Secondary outcomes: adherence rates, motivation, patient satisfaction, feasibility, and cost-effectiveness. Motor performance data will be captured in real time via XR tracking and transmitted to therapists for feedback.
Age range: Adults over 18 and under 70
Diagnosis of chronic low back pain with or without radiculopathy
Minimum of moderate disability (21% ODI score)
Acceptance of participation and signed consent form
History of spinal surgery or fracture
Signs of upper motor neuron injury: bilateral paresthesia, hyperreflexia, or spasticity, or other negative signs such as fractures
Other severe medical or psychological conditions that prevent participation in the trial.
Parallel
Mixed realities rehabilitation program
Other intervention1. Two sessions at the hospital: one session with traditional exercise + one session with traditional exercise and training with XR system ( 2 weeks) 2. Four more sessions at home with therapist (L1 therapist and L1 patients) (4 weeks) 3. Former sessions (until 120 days) with L3 therapist and L1 and L3 patients. Usual care: Group rehabilitation sessions: 8 weeks
Usual Care
Other interventionGroup rehabilitation sessions: 8 weeks
Pain intensity by VAS (0-100mm)
Significant change at 25 mm
Pain intensity by Brief Pain Inventory
Pain disability by Oswestry Disability Index (ODI)
Pain Kinesiophobia by Tampa Scale of Kinesiophobia (TSK)
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Universitat Jaume I
Lead sponsor
Hospital Vall d'Hebron
Collaborator
Villa Beretta Rehabilitation Center
Collaborator
German Research Center for Artificial Intelligence (DFKI)
Collaborator
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