Spinal Cord Injuries (SCI)NCT07165353
Virtual Walking to Reduce Chronic Neuropathic Pain in Subjects With SCI
A study testing Virtual Walking in people with Spinal Cord Injuries (SCI) and Neuropathic Pain Due to Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries (SCI), Neuropathic Pain Due to Spinal Cord Injury
- What is being tested?
- Virtual Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Jan 2026to 30 Nov 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sufficient knowledge of German language to understand the instructions, assessments and to fill in questionnaires.
- Age ≥ 18y, ≤ 75y
- Chronic traumatic or non-traumatic SCI (>6 month after SCI) with an SCI severity grade AIS A, B, C or D
- At or below level spinal cord injury neuropathic pain on trunk or lower extremities diagnosed by a neurologist following the ISCIP classification (Bryce et al., 2012) of at least 4/10 intensity on a NRS (Langford et al., 2023)
- Ability to draw with a pen
Who cannot join
- - Serious psychiatric disorders, which are accompanied by imminent or current acute harm to oneself or others, or which require inpatient psychiatric treatment for other reasons, or other indications of a foreseeable, seriously harmful effect of participation in the study based on the clinical impression from the psychological screening interview
- Participants with a walking ability more than 5 minutes without walking aids
- Pregnancy (anamnestic) in women of child-bearing age (18-49 years)
- Known epilepsy
- neurological disorders (multiple sclerosis, ALS, Guillan-Barré Syndrome, congenital disorders, polyneuropathy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Schweizer Paraplegiker Zentrum Nottwil
Nottwil, Canton of Lucerne, 6207
Gunther Landmann, KD Dr. med., 0041419394900, Gunther.landmann@paraplegie.ch
About this study
Official title: Virtual Walking With Habitual Feedback to Reduce Chronic Neuropathic Pain in Individuals With Spinal Cord Injury
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.
Read the detailed description
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..
- Being tested
- Virtual Walking, Sham Virtual Walking
- Keywords
- neuropathic pain, virtual walking, virtual reality, spinal cord injury pain, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual WalkingBehavioural
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.
Sham Virtual WalkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Behavioral: Virtual Walking |
| Group 2 | Sham comparator | 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. Receives: Behavioral: Sham Virtual Walking |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 15 weeks
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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).
Measured: Baseline, 4 and 12 weeks post-treatment
Neuropathic pain quality
Measured using the Neuropathic Pain Symptom Inventory (NPSI).
Measured: Baseline, 4 and 12 weeks post-treatment
Severity of chronic pain
Measured using the Chronic Pain Grading Scale (CPGS).
Measured: Baseline, 4 and 12 weeks post-treatment
Pain chronicity
Measured using the Mainz Pain Staging System (MPSS).
Measured: Baseline, 4 and 12 weeks post-treatment
General health-related quality of life
Measured using the Veterans RAND 12 Item Health Survey (VR-12).
Measured: 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).
Measured: Baseline, 4 and 12 weeks post-treatment
Pain catastrophizing
Measured using the Pain Catastrophizing Scale (PCS).
Measured: Baseline, 4 and 12 weeks post-treatment
Depression, anxiety, and stress
Measured using the Depression Anxiety and Stress Scale (DASS).
Measured: Baseline, 4 and 12 weeks post-treatment
Subjective impression of change
Measured using the Patient Global Impression of Change (PGIC).
Measured: 4 and 12 weeks post-treatment
Experienced emotions
Measured using the Scales for the Assessment of Emotional Experience (SEE).
Measured: Baseline, 4 and 12 weeks post-treatment
Positive outcomes after traumatic events
Measured using the Posttraumatic Growth Inventory (PTGI).
Measured: Baseline, 4 and 12 weeks post-treatment
Posttraumatic stress disorder
Measured using the International Trauma Questionnaire (ITQ).
Measured: 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)
Measured: Baseline
Severity grades of SCI
Assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS A-D)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start20 Jan 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injuries (SCI)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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gunther Landmann, KD Dr. med., Principal investigator, Schweizer Paraplegiker Zentrum Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165353
- Sponsor's protocol ID
- 2023-17
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Mahnig S, Landmann G, Stockinger L, Opsommer E. Pain assessment according to the International Spinal Cord Injury Pain classification in patients with spinal cord injury referred to a multidisciplinary pain center. Spinal Cord. 2016 Oct;54(10):809-815. doi: 10.1038/sc.2015.219. Epub 2016 Jan 12.
PubMed 26754471Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7.
PubMed 25575710Finnerup NB. Pain in patients with spinal cord injury. Pain. 2013 Dec;154 Suppl 1:S71-S76. doi: 10.1016/j.pain.2012.12.007. Epub 2012 Dec 22.
PubMed 23375163Wydenkeller S, Maurizio S, Dietz V, Halder P. Neuropathic pain in spinal cord injury: significance of clinical and electrophysiological measures. Eur J Neurosci. 2009 Jul;30(1):91-9. doi: 10.1111/j.1460-9568.2009.06801.x. Epub 2009 Jun 25.
PubMed 19558605Wrigley PJ, Press SR, Gustin SM, Macefield VG, Gandevia SC, Cousins MJ, Middleton JW, Henderson LA, Siddall PJ. Neuropathic pain and primary somatosensory cortex reorganization following spinal cord injury. Pain. 2009 Jan;141(1-2):52-9. doi: 10.1016/j.pain.2008.10.007. Epub 2008 Nov 21.
PubMed 19027233Widerstrom-Noga E, Biering-Sorensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Rosner J, Taylor J. The international spinal cord injury pain basic data set (version 3.0). Spinal Cord. 2023 Oct;61(10):536-540. doi: 10.1038/s41393-023-00919-w. Epub 2023 Jul 25.
PubMed 37491608Von Korff M, Ormel J, Keefe FJ, Dworkin SF. Grading the severity of chronic pain. Pain. 1992 Aug;50(2):133-149. doi: 10.1016/0304-3959(92)90154-4.
PubMed 1408309Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, Cleeland C, Dionne R, Farrar JT, Galer BS, Hewitt DJ, Jadad AR, Katz NP, Kramer LD, Manning DC, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robinson JP, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Witter J. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain. 2003 Dec;106(3):337-345. doi: 10.1016/j.pain.2003.08.001.
PubMed 14659516Trost Z, Anam M, Seward J, Shum C, Rumble D, Sturgeon J, Mark V, Chen Y, Mitchell L, Cowan R, Perera R, Richardson E, Richards S, Gustin S. Immersive interactive virtual walking reduces neuropathic pain in spinal cord injury: findings from a preliminary investigation of feasibility and clinical efficacy. Pain. 2022 Feb 1;163(2):350-361. doi: 10.1097/j.pain.0000000000002348.
PubMed 34407034Sommer C, Richter H, Rogausch JP, Frettloh J, Lungenhausen M, Maier C. A modified score to identify and discriminate neuropathic pain: a study on the German version of the Neuropathic Pain Symptom Inventory (NPSI). BMC Neurol. 2011 Aug 23;11:104. doi: 10.1186/1471-2377-11-104.
PubMed 21861889Richardson EJ, McKinley EC, Rahman AKMF, Klebine P, Redden DT, Richards JS. Effects of virtual walking on spinal cord injury-related neuropathic pain: A randomized, controlled trial. Rehabil Psychol. 2019 Feb;64(1):13-24. doi: 10.1037/rep0000246. Epub 2018 Nov 8.
PubMed 30407030Pfau DB, Krumova EK, Treede RD, Baron R, Toelle T, Birklein F, Eich W, Geber C, Gerhardt A, Weiss T, Magerl W, Maier C. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): reference data for the trunk and application in patients with chronic postherpetic neuralgia. Pain. 2014 May;155(5):1002-1015. doi: 10.1016/j.pain.2014.02.004. Epub 2014 Feb 10.
PubMed 24525274Ozkul C, Kilinc M, Yildirim SA, Topcuoglu EY, Akyuz M. Effects of visual illusion and transcutaneous electrical nerve stimulation on neuropathic pain in patients with spinal cord injury: A randomised controlled cross-over trial. J Back Musculoskelet Rehabil. 2015;28(4):709-19. doi: 10.3233/BMR-140573.
PubMed 25502348Opsommer E, Korogod N, Stockinger L, Landmann G. Multimodal sensory evaluation of neuropathic spinal cord injury pain: an experimental study. Spinal Cord. 2021 Aug;59(8):842-854. doi: 10.1038/s41393-020-00607-z. Epub 2021 Jan 14.
PubMed 33446934Moseley LG. Using visual illusion to reduce at-level neuropathic pain in paraplegia. Pain. 2007 Aug;130(3):294-298. doi: 10.1016/j.pain.2007.01.007. Epub 2007 Mar 1.
PubMed 17335974
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Walking With Habitual Feedback to Reduce Chronic Neuropathic Pain in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07165353
- Acronym / sponsor ID
- 2023-17
- Keywords
- neuropathic pain, virtual walking, virtual reality, spinal cord injury pain, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 10 Sep 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.
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.
Detailed description
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Virtual WalkingParticipants 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. |
| Group 2 | Sham comparator | Behavioral: Sham Virtual WalkingParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sufficient knowledge of German language to understand the instructions, assessments and to fill in questionnaires.
- Age ≥ 18y, ≤ 75y
- Chronic traumatic or non-traumatic SCI (>6 month after SCI) with an SCI severity grade AIS A, B, C or D
- At or below level spinal cord injury neuropathic pain on trunk or lower extremities diagnosed by a neurologist following the ISCIP classification (Bryce et al., 2012) of at least 4/10 intensity on a NRS (Langford et al., 2023)
- Ability to draw with a pen
Key exclusion criteria (5 listed)
- - Serious psychiatric disorders, which are accompanied by imminent or current acute harm to oneself or others, or which require inpatient psychiatric treatment for other reasons, or other indications of a foreseeable, seriously harmful effect of participation in the study based on the clinical impression from the psychological screening interview
- Participants with a walking ability more than 5 minutes without walking aids
- Pregnancy (anamnestic) in women of child-bearing age (18-49 years)
- Known epilepsy
- neurological disorders (multiple sclerosis, ALS, Guillan-Barré Syndrome, congenital disorders, polyneuropathy)
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 |
|---|---|---|
| Virtual WalkingThis 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. | Behavioural | Group 1 |
| Sham Virtual WalkingParticipants 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. | Behavioural | Group 2 |
Primary outcome
Proportion of participants with a clinically meaningful reduction in average pain intensity
Time frame: 15 weeks
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).
16 secondary outcomes
Change in pain distribution
Time frame: Baseline (1 week before intervention) to 2, 3, 4, 7, and 15 weeks after start of intervention
Change in pain distribution
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
Time frame: Baseline, 4 and 12 weeks post-treatment
Neuropathic pain quality
Time frame: Baseline, 4 and 12 weeks post-treatment
Severity of chronic pain
Time frame: Baseline, 4 and 12 weeks post-treatment
Pain chronicity
Time frame: Baseline, 4 and 12 weeks post-treatment
General health-related quality of life
Time frame: Baseline, 4 and 12 weeks post-treatment
General well-being
Time frame: Baseline, 4 and 12 weeks post-treatment
Pain catastrophizing
Time frame: Baseline, 4 and 12 weeks post-treatment
Depression, anxiety, and stress
Time frame: Baseline, 4 and 12 weeks post-treatment
Subjective impression of change
Time frame: 4 and 12 weeks post-treatment
Experienced emotions
Time frame: Baseline, 4 and 12 weeks post-treatment
Positive outcomes after traumatic events
Time frame: Baseline, 4 and 12 weeks post-treatment
Posttraumatic stress disorder
Time frame: Baseline, 4 and 12 weeks post-treatment
Clinical data
Time frame: Baseline
Severity grades of SCI
Time frame: Baseline
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 21 Jan 2026.
- Background: PubMed 26754471Mahnig S, Landmann G, Stockinger L, Opsommer E. Pain assessment according to the International Spinal Cord Injury Pain classification in patients with spinal cord injury referred to a multidisciplinary pain center. Spinal Cord. 2016 Oct;54(10):809-815. doi: 10.1038/sc.2015.219. Epub 2016 Jan 12.
- Background: PubMed 25575710Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7.
- Background: PubMed 23375163Finnerup NB. Pain in patients with spinal cord injury. Pain. 2013 Dec;154 Suppl 1:S71-S76. doi: 10.1016/j.pain.2012.12.007. Epub 2012 Dec 22.
- Results publication: PubMed 19558605Wydenkeller S, Maurizio S, Dietz V, Halder P. Neuropathic pain in spinal cord injury: significance of clinical and electrophysiological measures. Eur J Neurosci. 2009 Jul;30(1):91-9. doi: 10.1111/j.1460-9568.2009.06801.x. Epub 2009 Jun 25.
- Results publication: PubMed 19027233Wrigley PJ, Press SR, Gustin SM, Macefield VG, Gandevia SC, Cousins MJ, Middleton JW, Henderson LA, Siddall PJ. Neuropathic pain and primary somatosensory cortex reorganization following spinal cord injury. Pain. 2009 Jan;141(1-2):52-9. doi: 10.1016/j.pain.2008.10.007. Epub 2008 Nov 21.
- Results publication: PubMed 37491608Widerstrom-Noga E, Biering-Sorensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Rosner J, Taylor J. The international spinal cord injury pain basic data set (version 3.0). Spinal Cord. 2023 Oct;61(10):536-540. doi: 10.1038/s41393-023-00919-w. Epub 2023 Jul 25.
- Results publication: PubMed 1408309Von Korff M, Ormel J, Keefe FJ, Dworkin SF. Grading the severity of chronic pain. Pain. 1992 Aug;50(2):133-149. doi: 10.1016/0304-3959(92)90154-4.
- Results publication: PubMed 14659516Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, Cleeland C, Dionne R, Farrar JT, Galer BS, Hewitt DJ, Jadad AR, Katz NP, Kramer LD, Manning DC, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robinson JP, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Witter J. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain. 2003 Dec;106(3):337-345. doi: 10.1016/j.pain.2003.08.001.
- Results publication: PubMed 34407034Trost Z, Anam M, Seward J, Shum C, Rumble D, Sturgeon J, Mark V, Chen Y, Mitchell L, Cowan R, Perera R, Richardson E, Richards S, Gustin S. Immersive interactive virtual walking reduces neuropathic pain in spinal cord injury: findings from a preliminary investigation of feasibility and clinical efficacy. Pain. 2022 Feb 1;163(2):350-361. doi: 10.1097/j.pain.0000000000002348.
- Results publication: PubMed 21861889Sommer C, Richter H, Rogausch JP, Frettloh J, Lungenhausen M, Maier C. A modified score to identify and discriminate neuropathic pain: a study on the German version of the Neuropathic Pain Symptom Inventory (NPSI). BMC Neurol. 2011 Aug 23;11:104. doi: 10.1186/1471-2377-11-104.
- Results publication: PubMed 30407030Richardson EJ, McKinley EC, Rahman AKMF, Klebine P, Redden DT, Richards JS. Effects of virtual walking on spinal cord injury-related neuropathic pain: A randomized, controlled trial. Rehabil Psychol. 2019 Feb;64(1):13-24. doi: 10.1037/rep0000246. Epub 2018 Nov 8.
- Results publication: PubMed 24525274Pfau DB, Krumova EK, Treede RD, Baron R, Toelle T, Birklein F, Eich W, Geber C, Gerhardt A, Weiss T, Magerl W, Maier C. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): reference data for the trunk and application in patients with chronic postherpetic neuralgia. Pain. 2014 May;155(5):1002-1015. doi: 10.1016/j.pain.2014.02.004. Epub 2014 Feb 10.
- Individual participant dataSharing planned: 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.
Related trials for Spinal Cord Injuries (SCI)
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
RecruitingPhase 2/3
Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
Spinal Cord Injury, Traumatic Spinal Cord Injury
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
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.
Gunther Landmann, KD Dr. med. principal investigator
Schweizer Paraplegiker Zentrum Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Walking in people with Spinal Cord Injuries (SCI) and Neuropathic Pain Due to Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 5 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Karina Ottiger, MAS (+41419394900, karina.ottiger@paraplegie.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a clinically meaningful reduction in average pain intensity (time frame: 15 weeks). 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 NCT07165353, which also lists 31 linked publications.
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 21 Jan 2026.