Virtual Walking to Reduce Chronic Neuropathic Pain in Subjects With SCI

NCT07165353 | Recruiting

• 1 other identifier: 2023-17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Cord Injuries (SCI); Neuropathic Pain Due to Spinal Cord Injury

Keywords

neuropathic pain; virtual walking; virtual reality; spinal cord injury pain; spinal cord injury

Outcome Measures

Primary Outcomes (1)

• 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).

  15 weeks

Secondary Outcomes (16)

• Change in pain distribution

  Baseline (1 week before intervention) to 2, 3, 4, 7, and 15 weeks after start of intervention

• Change in pain distribution

  Baseline (1 week before intervention) to 2, 3, 4, 7, and 15 weeks after start of intervention

• Pain interference, diagnosis, type, and duration

  Baseline, 4 and 12 weeks post-treatment

• Neuropathic pain quality

  Baseline, 4 and 12 weeks post-treatment

• Severity of chronic pain

  Baseline, 4 and 12 weeks post-treatment

Study Arms (3)

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.

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.

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.

Interventions

Virtual Walking BEHAVIORAL

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.

Group 1

Sham Virtual Walking BEHAVIORAL

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.

Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Schweizer Paraplegiker Zentrum Nottwil

Nottwil, Canton of Lucerne, 6207, Switzerland

RECRUITING

Related Publications (31)

• 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.

  PMID: 26754471 BACKGROUND

• Finnerup 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.

  PMID: 25575710 BACKGROUND

• Finnerup 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.

  PMID: 23375163 BACKGROUND

• Wydenkeller 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.

  PMID: 19558605 RESULT

• Wrigley 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.

  PMID: 19027233 RESULT

• Widerstrom-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.

  PMID: 37491608 RESULT

• Von 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.

  PMID: 1408309 RESULT

• Turk 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.

  PMID: 14659516 RESULT

• Trost 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.

  PMID: 34407034 RESULT

• Sommer 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.

  PMID: 21861889 RESULT

• Richardson 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.

  PMID: 30407030 RESULT

• Pfau 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.

  PMID: 24525274 RESULT

• Ozkul 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.

  PMID: 25502348 RESULT

• Opsommer 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.

  PMID: 33446934 RESULT

• Moseley 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.

  PMID: 17335974 RESULT

• Magerl W, Krumova EK, Baron R, Tolle T, Treede RD, Maier C. Reference data for quantitative sensory testing (QST): refined stratification for age and a novel method for statistical comparison of group data. Pain. 2010 Dec;151(3):598-605. doi: 10.1016/j.pain.2010.07.026. Epub 2010 Oct 20.

  PMID: 20965658 RESULT

• Maercker, A. L., R. (2001). Persönliche Reifung (Personal Growth) durch Belastungen und Traumata. Diagnostica, VOL.47,NO.3. https://doi.org/https://doi.org/10.1026//0012-1924.47.3.153

  RESULT

• Langford DJ, Baron R, Edwards RR, Gewandter JS, Gilron I, Griffin R, Kamerman PR, Katz NP, McDermott MP, Rice ASC, Turk DC, Vollert J, Dworkin RH. What should be the entry pain intensity criteria for chronic pain clinical trials? An IMMPACT update. Pain. 2023 Sep 1;164(9):1927-1930. doi: 10.1097/j.pain.0000000000002930. Epub 2023 Jun 7. No abstract available.

  PMID: 37288944 RESULT

• Kumru H, Soler D, Vidal J, Navarro X, Tormos JM, Pascual-Leone A, Valls-Sole J. The effects of transcranial direct current stimulation with visual illusion in neuropathic pain due to spinal cord injury: an evoked potentials and quantitative thermal testing study. Eur J Pain. 2013 Jan;17(1):55-66. doi: 10.1002/j.1532-2149.2012.00167.x. Epub 2012 May 18.

  PMID: 22610590 RESULT

• Kirshblum SC, Burns SP, Biering-Sorensen F, Donovan W, Graves DE, Jha A, Johansen M, Jones L, Krassioukov A, Mulcahey MJ, Schmidt-Read M, Waring W. International standards for neurological classification of spinal cord injury (revised 2011). J Spinal Cord Med. 2011 Nov;34(6):535-46. doi: 10.1179/204577211X13207446293695. No abstract available.

  PMID: 22330108 RESULT

• Kazis LE, Miller DR, Skinner KM, Lee A, Ren XS, Clark JA, Rogers WH, Spiro A 3rd, Selim A, Linzer M, Payne SM, Mansell D, Fincke RG. Patient-reported measures of health: The Veterans Health Study. J Ambul Care Manage. 2004 Jan-Mar;27(1):70-83. doi: 10.1097/00004479-200401000-00012.

  PMID: 14717468 RESULT

• Gustin SM, Bolding M, Willoughby W, Anam M, Shum C, Rumble D, Mark VW, Mitchell L, Cowan RE, Richardson E, Richards S, Trost Z. Cortical Mechanisms Underlying Immersive Interactive Virtual Walking Treatment for Amelioration of Neuropathic Pain after Spinal Cord Injury: Findings from a Preliminary Investigation of Thalamic Inhibitory Function. J Clin Med. 2023 Sep 4;12(17):5743. doi: 10.3390/jcm12175743.

  PMID: 37685810 RESULT

• de Araujo AVL, Neiva JFO, Monteiro CBM, Magalhaes FH. Efficacy of Virtual Reality Rehabilitation after Spinal Cord Injury: A Systematic Review. Biomed Res Int. 2019 Nov 13;2019:7106951. doi: 10.1155/2019/7106951. eCollection 2019.

  PMID: 31828120 RESULT

• Christen D, Killikelly C, Maercker A, Augsburger M. Item Response Model Validation of the German ICD-11 International Trauma Questionnaire for PTSD and CPTSD. Clin Psychol Eur. 2021 Dec 23;3(4):e5501. doi: 10.32872/cpe.5501. eCollection 2021 Dec.

  PMID: 36398291 RESULT

• Charlifue S, Post MW, Biering-Sorensen F, Catz A, Dijkers M, Geyh S, Horsewell J, Noonan V, Noreau L, Tate D, Sinnott KA. International Spinal Cord Injury Quality of Life Basic Data Set. Spinal Cord. 2012 Sep;50(9):672-5. doi: 10.1038/sc.2012.27. Epub 2012 Mar 27.

  PMID: 22450884 RESULT

• Braunwalder C, Muller R, Kunz S, Tough H, Landmann G, Fekete C. Psychosocial resources and chronic pain in individuals with spinal cord injury: evidence from the second Swiss national community survey. Spinal Cord. 2021 Apr;59(4):410-418. doi: 10.1038/s41393-020-00577-2. Epub 2020 Nov 19.

  PMID: 33214625 RESULT

• Braunwalder C, Ehrmann C, Hodel J, Muller R, von Matt D, Fekete C. Pain Trajectories During Initial Rehabilitation After Spinal Cord Injury: Do Psychosocial Resources and Mental Health Predict Trajectories? Arch Phys Med Rehabil. 2022 Jul;103(7):1294-1302. doi: 10.1016/j.apmr.2022.01.149. Epub 2022 Feb 11.

  PMID: 35157891 RESULT

• Bouhassira D, Branders S, Attal N, Fernandes AM, Demolle D, Barbour J, Ciampi de Andrade D, Pereira A. Stratification of patients based on the Neuropathic Pain Symptom Inventory: development and validation of a new algorithm. Pain. 2021 Apr 1;162(4):1038-1046. doi: 10.1097/j.pain.0000000000002130.

  PMID: 33136982 RESULT

• Biering-Sorensen F, Charlifue S, Chen Y, New PW, Noonan V, Post MWM, Rupp R, Vogel L. International Spinal Cord Injury Core Data Set (version 3.0)-including standardization of reporting. Spinal Cord. 2023 Jan;61(1):65-68. doi: 10.1038/s41393-022-00862-2. Epub 2022 Oct 28.

  PMID: 36307730 RESULT

• Schmerz.) Behr, M. B., M. . (2004). Skalen zum Erleben von Emotionen (SEE). Göttingen: Hogrefe.

  RESULT

• Aerni, M. (2020). Machbarkeitsstudie: Virtual walking bei Personen mit neuropathischen Schmerzen infolge Querschnittlähmung. . Master thesis, University of applied sciences Zurich.

  RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gunther Landmann, KD Dr. med.

  Schweizer Paraplegiker Zentrum Nottwil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina Ottiger, MAS

CONTACT

+41419394900; karina.ottiger@paraplegie.ch

Gunther Landmann, KD Dr. med.

CONTACT

+41419394900; gunther.landmann@paraplegie.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)