Virtual Walking With Habitual Feedback to Reduce Chronic Neuropathic Pain in Individuals With Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Proportion of participants with a clinically meaningful reduction in average pain intensity
Study Overview
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.
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •- 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)
Arms & Interventions
Group 1
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.
Intervention: Virtual Walking (Behavioral)
Group 2
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.
Intervention: Sham Virtual Walking (Behavioral)
Control Group
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.
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Change in pain distribution(Baseline (1 week before intervention) to 2, 3, 4, 7, and 15 weeks after start of intervention)
- Neuropathic pain quality(Baseline, 4 and 12 weeks post-treatment)
- Subjective impression of change(4 and 12 weeks post-treatment)
- Pain interference, diagnosis, type, and duration(Baseline, 4 and 12 weeks post-treatment)
- Severity of chronic pain(Baseline, 4 and 12 weeks post-treatment)
- Pain chronicity(Baseline, 4 and 12 weeks post-treatment)
- Experienced emotions(Baseline, 4 and 12 weeks post-treatment)
- General health-related quality of life(Baseline, 4 and 12 weeks post-treatment)
- General well-being(Baseline, 4 and 12 weeks post-treatment)
- Pain catastrophizing(Baseline, 4 and 12 weeks post-treatment)
- Depression, anxiety, and stress(Baseline, 4 and 12 weeks post-treatment)
- Clinical data(Baseline)
- Positive outcomes after traumatic events(Baseline, 4 and 12 weeks post-treatment)
- Posttraumatic stress disorder(Baseline, 4 and 12 weeks post-treatment)
- Severity grades of SCI(Baseline)
