Chronic Low Back Pain (CLBP)NCT07202975
RE-SCALE: Rehabilitation Engagement and Scaled Access With eXtended Reality and Artificial Intelligence
A study testing Mixed realities rehabilitation program in people with Chronic Low Back Pain (CLBP), run by Universitat Jaume I.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Mixed realities rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Internet access at home
Who cannot join
- 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.
About this study
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.
Read more
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:
- To conduct a two-site randomized controlled trial (RCT) comparing XR rehabilitation with conventional group rehabilitation.
- To assess both short-term and long-term outcomes (pain intensity, disability, kinesiophobia).
- To monitor and improve adherence through ecological momentary assessment and intervention (EMA/EMI) using an app and activity trackers.
- To enhance motivation and engagement with gamification, social connectedness, and avatar-based interaction.
- 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.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Mixed realities rehabilitation program, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed realities rehabilitation programOther
- Two sessions at the hospital: one session with traditional exercise + one session with traditional exercise and training with XR system ( 2 weeks)
- Four more sessions at home with therapist (L1 therapist and L1 patients) (4 weeks)
- Former sessions (until 120 days) with L3 therapist and L1 and L3 patients. Usual care: Group rehabilitation sessions: 8 weeks
Usual CareOther
Group rehabilitation sessions: 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mixed realities rehabilitation program | Experimental | 1. 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. Receives: Other: Mixed realities rehabilitation program |
| Usual Care | Active comparator | Group rehabilitation sessions: 8 weeks Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity by VAS (0-100mm)
Significant change at 25 mm
Measured: Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18
Pain intensity by Brief Pain Inventory
Measured: Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18
Pain disability by Oswestry Disability Index (ODI)
Measured: Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18
Pain Kinesiophobia by Tampa Scale of Kinesiophobia (TSK)
Measured: Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-site randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Villa Beretta Rehabilitation Center, German Research Center for Artificial Intelligence (DFKI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202975
- Sponsor's protocol ID
- RE-SCALE
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoffman HG, Fontenot MR, Garcia-Palacios A, Greenleaf WJ, Alhalabi W, Curatolo M, Flor H. Adding tactile feedback increases avatar ownership and makes virtual reality more effective at reducing pain in a randomized crossover study. Sci Rep. 2023 May 22;13(1):7915. doi: 10.1038/s41598-023-31038-4.
PubMed 37217536
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RE-SCALE: Rehabilitation Engagement and Scaled Access With eXtended Reality and Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07202975
- Acronym / sponsor ID
- RE-SCALE
- Conditions
- Chronic Low Back Pain (CLBP)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Villa Beretta Rehabilitation Center, German Research Center for Artificial Intelligence (DFKI)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To conduct a two-site randomized controlled trial (RCT) comparing XR rehabilitation with conventional group rehabilitation.
- To assess both short-term and long-term outcomes (pain intensity, disability, kinesiophobia).
- To monitor and improve adherence through ecological momentary assessment and intervention (EMA/EMI) using an app and activity trackers.
- To enhance motivation and engagement with gamification, social connectedness, and avatar-based interaction.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-site randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Mixed realities rehabilitation program | Experimental | Other: Mixed realities rehabilitation program1. 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 | Active comparator | Other: Usual CareGroup rehabilitation sessions: 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Internet access at home
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed realities rehabilitation program1. 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 | Other | Mixed realities rehabilitation program |
| Usual CareGroup rehabilitation sessions: 8 weeks | Other | Usual Care |
Primary outcome
Pain intensity by VAS (0-100mm)
Time frame: Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18
Significant change at 25 mm
Pain intensity by Brief Pain Inventory
Time frame: Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18
Pain disability by Oswestry Disability Index (ODI)
Time frame: Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18
Pain Kinesiophobia by Tampa Scale of Kinesiophobia (TSK)
Time frame: Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Results publication: PubMed 37217536Hoffman HG, Fontenot MR, Garcia-Palacios A, Greenleaf WJ, Alhalabi W, Curatolo M, Flor H. Adding tactile feedback increases avatar ownership and makes virtual reality more effective at reducing pain in a randomized crossover study. Sci Rep. 2023 May 22;13(1):7915. doi: 10.1038/s41598-023-31038-4.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed realities rehabilitation program in people with Chronic Low Back Pain (CLBP), run by Universitat Jaume I.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity by VAS (0-100mm) (time frame: Baseline, through study completion, an average of 8 week and follow-up at 6, 12 and 18). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07202975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.