Neuralgia
Conditions
Brief summary
This study has two objectives. First, to introduce a new virtual reality method that incorporates the mechanisms used in mirror visual feedback through a three-dimensional (3D) augmented virtual reality system. Second, to evaluate the efficiency of this new method on a convenience sample of patients presenting with unresolved neuropathic pain (CRPS, PLP, plexopathy, stroke) who were not responding adequately to both pharmaceutical management and traditional mirror therapy.
Detailed description
Each patient receives 5 treatment periods over a total period of 1 week, where each treatment period lasts a total of 20 minutes.
Interventions
DEVICE3D augmented reality
Each treatment period included a 3DARS (3D augmented reality system)training session.All 3DARS training sessions were performed in the same quiet room under the supervision of the same single investigator.The 3DARS training session protocol included two virtual training procedures. The first virtual training procedure consisted of applying a vertical virtual mirror to the display screen, where the non-affected side of the patient's body (such as the right) was symmetrically duplicated by a vertical axis on the affected side (such as the left).The second virtual training procedure consisted of flipping the 3D image horizontally along a vertical axis. This allowed patients to observe the reflection of their non-affected upper extremity as if it was the affected one.
Sponsors
Erasme University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Neuropathic pain in the unilateral upper extremity scored by DN4 questionnaire * At least 3 months symptom duration following injury * Minimum pain of 40 on a visual analogue scale (VAS); * A drug treatment regimen that was stable for at least 2 weeks. * Subjects were allowed to participate if they presented with any of the following: (1) A CRPS diagnosis, in accordance with the International Association for the Study of Pain criteria, Phantom Limb Pain (PLP), or spinal cord injury or plexopathy; and (2) an history of being treated before by conventional mirror therapy but, in their case, the mirror therapy failed.
Exclusion criteria
* Bilateral injury, * Patients with epilepsy * Side effects known to 3D (such as nausea, cephalalgia) * Cognitive disorder * Poor knowledge of the French language.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on the Visual Analog Scale (VAS) | baseline and week | Visual Analogic Scale assessed pain intensity before and after the intervention. Possible scores range from 0 (no pain) to 10 (worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Pain Assessed With DN4 Questionnaire | 1 week | DN4 (Douleur Neuropathique en 4 Questions) is a screening tool for neuropathic pain consisting of interview questions (DN4-interview) and physical tests. When the practitioner suspects neuropathic pain, the DN4 questionnaire is useful as a diagnostic tool. This questionnaire is divided into 4 questions representing 10 check items: * The practitioner questions the patient himself and completes the questionnaire * For each item, he must provide a yes or no answer * At the end of the questionnaire, the practitioner counts the responses, 1 for each Yes and 0 for each no. * The sum obtained gives the Patient Score, noted out of 10. If the patient's score is 4/10 or more, the test is positive (sensitivity at 82.9%; specificity at 89.9%) Dn4 questionnaire were completed before and 24 hour after the last session |
Other
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire de Saint-Antoine | 1 week | French adaptation of Melzack's MC Gill Pain Questionnaire (MPQ). It is a questionnaire of 61 qualifying words divided into 17 subclasses: 9 sensory, 7 emotional, 1 evaluative. The patient is asked to select the adjectives and then rate them from 0 (not at all) to 4 (extremely). This self-assessment scale allows clinical practice to specify the participation of the sensory and the emotional in pain intensity. self-questionnaire scoring the sensory and emotional qualities of the pain |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label 3D augmented reality | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Open Label |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment Belgium | 22 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Pain on the Visual Analog Scale (VAS)
Visual Analogic Scale assessed pain intensity before and after the intervention. Possible scores range from 0 (no pain) to 10 (worst possible pain)
Time frame: baseline and week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label | Pain on the Visual Analog Scale (VAS) | vas baseline | 6.4 units on a scale | Standard Deviation 2.3 |
| Open Label | Pain on the Visual Analog Scale (VAS) | vas after 1 week | 4.0 units on a scale | Standard Deviation 2.4 |
Secondary
Neuropathic Pain Assessed With DN4 Questionnaire
DN4 (Douleur Neuropathique en 4 Questions) is a screening tool for neuropathic pain consisting of interview questions (DN4-interview) and physical tests. When the practitioner suspects neuropathic pain, the DN4 questionnaire is useful as a diagnostic tool. This questionnaire is divided into 4 questions representing 10 check items: * The practitioner questions the patient himself and completes the questionnaire * For each item, he must provide a yes or no answer * At the end of the questionnaire, the practitioner counts the responses, 1 for each Yes and 0 for each no. * The sum obtained gives the Patient Score, noted out of 10. If the patient's score is 4/10 or more, the test is positive (sensitivity at 82.9%; specificity at 89.9%) Dn4 questionnaire were completed before and 24 hour after the last session
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label | Neuropathic Pain Assessed With DN4 Questionnaire | before | 6.5 units on a scale | Standard Deviation 2.3 |
| Open Label | Neuropathic Pain Assessed With DN4 Questionnaire | 24H after the last treatment | 5.5 units on a scale | Standard Deviation 2.3 |
Other Pre-specified
Questionnaire de Saint-Antoine
French adaptation of Melzack's MC Gill Pain Questionnaire (MPQ). It is a questionnaire of 61 qualifying words divided into 17 subclasses: 9 sensory, 7 emotional, 1 evaluative. The patient is asked to select the adjectives and then rate them from 0 (not at all) to 4 (extremely). This self-assessment scale allows clinical practice to specify the participation of the sensory and the emotional in pain intensity. self-questionnaire scoring the sensory and emotional qualities of the pain
Time frame: 1 week