Virtual Walking to Reduce Chronic Neuropathic Pain in Subjects With SCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSwiss Paraplegic Research, Nottwil
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
- 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
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Walking
BehavioralThis 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 Walking
BehavioralParticipants 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.
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Sham comparator 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
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).
Time frame
15 weeksSecondary outcomes
1
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 intervention2
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 intervention3
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-treatment4
Neuropathic pain quality
Measured using the Neuropathic Pain Symptom Inventory (NPSI).
Time frame
Baseline, 4 and 12 weeks post-treatmentSponsors and contacts
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Source ClinicalTrials.gov