An interventional study of Virtual Walking and Sham Virtual Walking in Spinal Cord Injuries (SCI) and Neuropathic Pain Due to Spinal Cord Injury, sponsored by Swiss Paraplegic Research, Nottwil. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Swiss Paraplegic Research, Nottwil · Not applicable, Interventional, and Treatment
About 70% of people with a spinal cord injury in Switzerland have chronic pain that lasts more than 3 to 6 months. This pain can be caused by muscle or joint problems, or by nerve damage (neuropathic pain). Neuropathic pain is often hard to treat, and current treatments may cause side effects or not work well.
This study will test whether virtual walking from different visual perspectives can reduce chronic neuropathic pain and improve quality of life after spinal cord injury. We will also compare which perspective works best.
To better understand how the training works, we will use two tests-quantitative sensory testing (QST) and contact heat-evoked potentials (CHEPs)-to measure changes in the pain and nerve systems.
Chronic pain conditions are highly prevalent in the Swiss spinal cord injury (SCI) population with a prevalence of 73% (Müller et al., 2017). Most of those individuals show multiple pain modalities (neuropathic, nociceptive and unknown pain type) (Mahnig et al., 2016; Siddall et al., 2003). For example, Mahnig et al. (2016) reported prevalences of 79% neuropathic and 61% nociceptive pain in individuals with SCI seen in a pain clinic. The current practice of pharmacological first- and second-line treatments comes along with many side effects and unsatisfactory results (Finnerup et al., 2015). This is because the underlying biology of chronic neuropathic pain (NeP) and the mechanisms that lead to chronification of pain are highly complex and not fully understood. Latest research suggests that chronification of pain is associated with anatomical and functional reorganization of the brain (Reckziegel et al., 2019; Wrigley et al., 2009). More specifically, cortical grey matter density changes and neuroanatomical reorganization of the primary somatosensory cortex are discussed as factors associated with pain chronification. Additional mechanisms proposed to explain NeP after SCI include spinal cord plasticity, supraspinal reorganization, and increased neuronal excitability of dorsal horn neurons (Finnerup, 2013).
MRI data show, that there is a correlation between the grade of cortical reorganisation and pain intensity in people with complete SCI (Gustin et al., 2023). However, it is unclear whether there is a systematic influence of the severity of the SCI lesion, graded by the American Spinal Injury Association (ASIA) Impairment Scale (complete or incomplete SCI), on pain intensity.
Alongside with studies about pain mechanisms and improved pharmaceutical treatment, non-invasive and non-pharmacological alternative treatments with minimal side effects have been investigated, such as, for example virtual reality (VR). Changes of pain perception due to VR interventions in individuals with neuropathic spinal cord injury pain (SCIP) are described in the literature (Eick \& Richardson, 2015; Kumru et al., 2013; Moseley, 2007; Özkul et al., 2015; Soler et al., 2010; Trost et al., 2022). Recent reviews have shown good short-term effects of VR in the treatment of SCIP (Chi et al., 2019; de Araújo et al., 2019). However, there is lack of evidence from randomized controlled trials.
Chronic pain in SCI is often modulated by psycho-social factors such as depression, anxiety, extent of social support and pain catastrophising (Braunwalder et al., 2022; Braunwalder et al., 2021; Müller et al., 2017; Wollaars et al., 2007). Data about the influence of psycho-social factors on VR therapy are only reported for VR therapy in first person perspective (Trost et al., 2022). Data about the influence of psycho-social factors third person perspective are not available.
Recently, a virtual walking (VW) treatment protocol in third person perspective inclusive an additional haptic feedback modality (controlled movement of the wheelchair seat to improve the walking immersion) has been set up and evaluated within a feasibility study with individuals with SCIP, reporting a high level of satisfaction and acceptance of the VW procedure at the Centre for Pain Medicine, Swiss Paraplegic Centre (SPC), Nottwil. In this uncontrolled explorative trial, there was a tendency towards reduced pain intensity and spread of reported pain after VW (Aerni, 2020).
To better understand individual responses to VR and explore underlying pain mechanisms, neurophysiological assessments such as quantitative sensory testing (QST) and contact heat-evoked potentials (CHEPs) are used as biomarkers to identify sensory phenotypes.
To address the challenges of assessing and treating pain following SCI, the systematic evaluation of all somatosensory submodalities is strongly recommended for both pathophysiological research and treatment trials in individuals with SCI-related pain (Finnerup, 2013).
Landmann et al. (2024) demonstrated that QST can identify distinct sensory phenotypes in individuals with neuropathic spinal cord injury pain (SCIP). Furthermore, the combination of QST and CHEPs enables objective and standardized measurement of sensory system alterations, thereby contributing to a better understanding of underlying mechanisms (Opsommer et al., 2021).
The aim of the present study is to evaluate (1) the efficiency of the standardised VW-setting with regard to pain reduction in subjects with complete and incomplete SCI, (2) bio-psycho-social prognostic factors which may influence the efficacy of VR, and (3) the influence of VR on psycho-social characteristics of subjects with SCI and (4) to identify pain and sensory phenotypes in individuals with SCIP and examine whether these phenotypes are associated with differential effects of VR on pain reduction..
Exclusion Criteria:
Participants will receive virtual walking (VW) therapy with a personalized avatar. Using a green screen setup, a live video of the participant's upper body is combined with pre-recorded walking legs to create a full-body walking illusion, displayed on a large projection screen in a forest environment. The participant will be seated in a modified wheelchair that tilts 2° to each side to simulate pelvic movement during walking.
Behavioral: Virtual Walking
Participants will receive virtual walking (VW) therapy without an avatar. The screen will display only a moving forest environment, and the wheelchair tilt will be omitted. This condition serves as a sham intervention, matching Group 1 in session number, duration, and procedure, but without the visual and vestibular walking components.
Behavioral: Sham Virtual Walking
Participants will receive standard medical pain management only. They will not take part in virtual walking therapy but will complete the pain diary and questionnaires at the scheduled assessment time points.
This virtual walking therapy uses a life-sized video avatar of the participant walking through a forest environment. A green screen setup combines a live video of the participant's upper body with pre-recorded walking legs, creating a full-body walking illusion. The participant is seated in a modified wheelchair that tilts 2° to each side to mimic pelvic movement during walking. This approach differs from the sham condition (Group 2), which displays only the moving forest without an avatar or wheelchair tilt, and from the standard care group (Group 3), which receives no virtual walking therapy.
Participants view a moving forest environment on a large projection screen for 10 sessions over 2 weeks (each up to 20 minutes). No avatar of the participant is displayed, and the wheelchair tilt function is disabled. This differs from the experimental intervention (Group 1), which includes a life-sized walking avatar and wheelchair tilt to mimic pelvic movement, and from the standard care group (Group 3), which receives no virtual walking therapy.
Proportion of participants with a clinically meaningful reduction in average pain intensity
The primary outcome is the percentage of participants achieving a reduction of ≥1 point on the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) for average pain intensity. Pain intensity is assessed daily using a pain diary over one week, measured at 4 weeks and 12 weeks after the end of treatment, compared to baseline (1 week before treatment start).
Time frame: 15 weeks
Change in pain distribution
Extent of pain area (size in pixels and percentage of total body chart) indicated by the participant on a standardized pain drawing.
Time frame: Baseline (1 week before intervention) to 2, 3, 4, 7, and 15 weeks after start of intervention
Change in pain distribution
Average pain intensity measured daily using a pain diary and the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) over one week at each time point, compared to baseline.
Time frame: Baseline (1 week before intervention) to 2, 3, 4, 7, and 15 weeks after start of intervention
Pain interference, diagnosis, type, and duration
Measured using the Spinal Cord Injury Pain Basic Data Set (SCIP-BDS 3.0).
Time frame: Baseline, 4 and 12 weeks post-treatment
Neuropathic pain quality
Measured using the Neuropathic Pain Symptom Inventory (NPSI).
Time frame: Baseline, 4 and 12 weeks post-treatment
Severity of chronic pain
Measured using the Chronic Pain Grading Scale (CPGS).
Time frame: Baseline, 4 and 12 weeks post-treatment
Pain chronicity
Measured using the Mainz Pain Staging System (MPSS).
Time frame: Baseline, 4 and 12 weeks post-treatment
General health-related quality of life
Measured using the Veterans RAND 12 Item Health Survey (VR-12).
Time frame: Baseline, 4 and 12 weeks post-treatment
General well-being
Measured using the Spinal Cord Injury Quality of Life Basic Data Set (SCI-QoL-BDS) and the Marburg Questionnaire on Habitual Well-being (FW-7).
Time frame: Baseline, 4 and 12 weeks post-treatment
Pain catastrophizing
Measured using the Pain Catastrophizing Scale (PCS).
Time frame: Baseline, 4 and 12 weeks post-treatment
Depression, anxiety, and stress
Measured using the Depression Anxiety and Stress Scale (DASS).
Time frame: Baseline, 4 and 12 weeks post-treatment
Subjective impression of change
Measured using the Patient Global Impression of Change (PGIC).
Time frame: 4 and 12 weeks post-treatment
Experienced emotions
Measured using the Scales for the Assessment of Emotional Experience (SEE).
Time frame: Baseline, 4 and 12 weeks post-treatment
Positive outcomes after traumatic events
Measured using the Posttraumatic Growth Inventory (PTGI).
Time frame: Baseline, 4 and 12 weeks post-treatment
Posttraumatic stress disorder
Measured using the International Trauma Questionnaire (ITQ).
Time frame: Baseline, 4 and 12 weeks post-treatment
Clinical data
Includes age, gender, age at injury, lesion level, completeness of lesion, grade of motor function, concomitant injuries, pain quality, and medication, obtained from clinical records or assessed by the International SCI Core Data Set (I-SCI-CDS)
Time frame: Baseline
Severity grades of SCI
Assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS A-D)
Time frame: Baseline
Plan to share: No — Individual participant data will not be shared because the informed consent and ethics approval do not include permission for data sharing, and to ensure protection of participant privacy.
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Swiss Paraplegic Research, Nottwil