The goal of this single-subject design is to evaluate an intervention combining neuromodulation, virtual reality, and muscle vibration to reduce neuropathic pain in individuals following a spinal cord injury.
The investigators aim to quantify the effects of the intervention on the intensity and characteristics of neuropathic pain, as well as its impact on daily functioning in individuals undergoing SCI rehabilitation. Additionally, the investigators seek to gain a better understanding of participants' experiences with the intervention by exploring effects not captured by standardized questionnaires, and by examining the role and meaning of the intervention in their management and experience of pain.
Finally, the investigators aim to assess the feasibility and clinical relevance of implementing this intervention in a rehabilitation setting.
All participants living with neuropathic pain following a spinal cord injury will take part in ten intervention sessions. They will also be invited to complete standardized questionnaires and participate in a semi-structured interview. In addition, their clinicians will be invited to participate in a focus group.
over 18 years old
a score of ≥ 4/10 on the Douleur Neuropathique en 4 Questions (DN4)
classified AIS A to D
neuropathic pain with an intensity of ≥ 4/10 on the simple numerical rating scale (This threshold is often chosen to better observe a potential analgesic effect)
pregnancy,
epilepsy,
cancer,
pacemaker,
Single group
Transcranial Direct Current Stimulation (tDCS) combined with virtual reality and muscle vibration
DevicetDCS will be delivered over the primary motor cortex (M1) to maximize the analgesic effect. The cathode will be positioned over the suborbital region, and the anode over M1 (position C3 or C4 of the international 10-20 system). A 2 mA direct current will be applied. Participants will observe, through virtual reality goggles (HTC Vive), an avatar walking from a first-person perspective, synchronized with the vibration pattern. Twelve vibrators will be placed transversely and bilaterally over the tendons of the main flexors and extensors of the lower limbs. The pattern used to trigger the vibrators is based on the natural sequence of gait movement. Muscle vibration induces a perception of movement in the direction of muscle elongation. The target frequency of the vibrators will be 80 Hz. The session will begin with 5 minutes of tDCS alone, and then for the last 15minutes the investigators will combine tDCS, virtual reality and muscle vibration.
Pain intensity
Pain intensity will be measured with Numeric rating scale, an 11-point scale to measure pain intensity, ranging from 0 (no pain) to 10 (worst possible pain). In the case of pain after spinal cord injury, the minimum clinically significant change would be around 1.8 points. Test-retest reliability ranged from 0.63 to 0.92, with intra- and inter-rater reliability of 0.84-0.98
Pain interference
The investigators extracted the interference section containing 3 items from the "international spinal cord injury pain basic data set data collection form - Version 3.0" in order to measure pain interference on daily activities, mood and sleep over the last 7 days. For each self-administered question, interference is measured on a scale from 0 (no interference) to 10 (maximum interference). The total score ranges from 0 to 30, a higher score means a greater pain interference.This questionnaire has been validated in people after spinal cord injury.
Pain characteristics
Pain characteristics measured with PainDETECT. A tool initially developed to detect neuropathic components in people with chronic pain in the lumbar region. This questionnaire is increasingly used for other conditions, including post-spinal cord injury, helping to establish an individualized pain profile. It is also used in brain imaging studies. There are 9 items, 7 on sensory characteristics and 2 on temporal and spatial characteristics. It is scored from 0 to 38. A total of 19 or more indicates a high probability of having a neuropathic component.
Participant satisfaction rating for the Intervention
The research team developed a questionnaire to assess overall satisfaction with the intervention, as well as satisfaction with the timing, frequency, duration, content, and format of the sessions. There are 9 items, the satisfaction related to each item is scored on a scale 0 (not at all satisfied) to 10 (extremely satisfied). The total score ranges from 0 to 90, a higher score means a greater satisfaction of the participant regarding the intervention.
Qualitative themes from semi-structured interviews on perceived effects, embodiment, feasibility, and personal impact of the intervention in the participant with neuropathic pain after a spinal cord injury (SCI)
Semi-structured interviews will be conducted with participants with neuropathic pain after a SCI. Each interview will last approximately 60 minutes and will follow a guide developed to structure the discussion. Thematic areas will include rehabilitation needs, overall experience with the intervention, perceived effects, embodiment, feasibility, suggestions regarding both positive and negative aspects, and for improving the intervention (for example in terms of effects or feasibility). How the intervention contributes to individuals' self-perception and interpretation of their pain experience will be also investigated. These interviews will be audio-recorded.
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