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Number of centres planned : 1 (CHU Nantes)
Design : Randomized, Prospective
Planning of the study :
Expected number of cases : 12
Treatment, procedure, combination of procedures under consideration :
During the study, patients will be implanted with the WAVEWRITER ALPHA™ system with the objective of decreasing patient pain with a spinal cord stimulation mode.
There will be a random draw on the order of the stimulation program:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population | Experimental | 12 patients with neck and upper limb pain who have failed multidisciplinary treatment and are candidates for cervical medullary stimulation will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of the WAVEWRITER ALPHA ™ device | Device | The 12 patients will be implanted by the WAVEWRITER ALPHA ™ device. Then, the order of the three stimulation modes will be randomly selected and will be composed of 5 modalities:
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode. | Comparison of the average of the visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome)score collected during the 7 days of stimulation by the Tonic+Burst mode to the average of the visual analogic scale score collected during the 7 days in tonic stimulation | 6 Months |
| Evaluating the overall satisfaction with the stimulation mode | Daily collection of the patient's evaluation of his satisfaction on the remote control - the patient's logbook by a number of stars: 1* (one star) not satisfied and 5* (five stars) very satisfied | 6 Months |
| Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode. | Comparison of the average visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome) score of the 7 days of the Tonic+Burst mode compared to the average visual analogic scale scores collected in Tonic stimulation alone. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the non-inferiority of patient pain with the combined mode compared to the low frequency reference mode | Comparison of the average of the visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome) scores collected during the 7 days of stimulation by the combined Tonic+High Frequency mode to the average of the visual analogic scale scores collected during the 7 days of tonic stimulation. |
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Inclusion criteria:
Non-inclusion criteria:
Exclusion criteria:
- 7-day post-implantation test phase negative
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvie RAOUL | Contact | 02 40 16 50 80 | sylvie.raoul@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Recruiting | Nantes | 44093 | France |
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| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Hierarchical sequential study with a fixed sequence of 3 successive hypotheses = tested with a 5% risk until one hypothesis is rejected. These three successive hypotheses are a non-inferiority test, followed by two superiority tests.
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Patients will only know the stimulation modes
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|
| 6 Months |
| Evaluating the non-inferiority of patient satisfaction with their overall comfort | Daily collection of the patient's evaluation of his satisfaction on the patient's notebook by a number of stars: 1* (one star) not satisfied and 5* (five stars) very satisfied. During the 7 days of stimulation by Low frequency + High frequency. | 6 Months |
| Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode. | Comparison of the average visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome) score of the 7 days of the combined mode Tonic+ High Frequency compared to the average visual analogic scale scores collected in Tonic stimulation alone | 6 Months |
| Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + burst vs Low frequency | Daily collection of the patient's evaluation of his or her satisfaction on the patient logbook by a number of stars: 1* (one star) not satisfied and 5* (five stars) very satisfied. | 6 Months |
| Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + high frequency vs Low frequency | Daily collection of the patient's evaluation of his or her satisfaction on the patient logbook by a number of stars: 1* (one star) not satisfied and 5* (five stars) very satisfied. | 6 Months |
| Evaluating the superioty of pain reduction with the combined mode (low frequency + high frequency) compared to the tonic mode (low frequency) only | Daily collection of the pain felt during the day (visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome)) during the 7 consecutive days of stimulation of the same mode. | 6 Months |
| Evaluating the superioty of pain reduction with the combined mode (low frequency + Burst) compared to the tonic mode (low frequency) only | Daily collection of the pain felt during the day (visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome)) during the 7 consecutive days of stimulation of the same mode. | 6 Months |
| Evaluate the equality of the effectiveness of the new modes (Burst, high frequency, Tonic + Burst, Tonic + high frequency) compared to the tonic mode alone on the pain criteria | Daily collection of the pain felt during the day (visual analogic scale (scale from 0 to 10 ; 10 being the worst outcome)) during the 7 consecutive days of stimulation of the same mode. | 6 Months |
| Evaluate the equality of the effectiveness of the new modes (Burst, high frequency, Tonic + Burst, Tonic + high frequency) compared to the tonic mode alone on the satisfaction | Daily collection of the patient's evaluation of his or her satisfaction on the patient logbook by a number of stars: 1* (one star) not satisfied and 5* (five stars) very satisfied. | 6 Months |
| Comparison of the number of recharges of the device according to the stimulation modes | Number of recharges of the remote control during the 7 days of stimulation. | 6 Months |
| Evaluating the change in the quality of life of patients at 1 month | Comparison of the evolution of quality of life from inclusion to 1 month with the Hospital Anxiety and Depression scale (scale from 0 to 3; 3 being the worst outcome) | 1 month |
| Evaluating the change in the quality of life of patients at 1 month | Comparison of the evolution of quality of life from inclusion to 1 month with the EuroQol 5 Dimensions (scale from 0 to 100; 100 being the worst outcome) | 1 month |
| Evaluating the change in the quality of life of patients at 3 months | Comparison of the evolution of quality of life from inclusion to 3 months with the Hospital Anxiety and Depression scale (scale from 0 to 3; 3 being the worst outcome) | 3 months |
| Evaluating the change in the quality of life of patients at 3 months | Comparison of the evolution of quality of life from inclusion to 3 months with the EuroQol 5 Dimensions (scale from 0 to 100; 100 being the worst outcome) | 3 months |
| Evaluating the change in the quality of life of patients at 6 months | Comparison of the evolution of quality of life from inclusion to 6 months with the Hospital Anxiety and Depression scale (scale from 0 to 3; 3 being the worst outcome) | 6 months |
| Evaluating the change in the quality of life of patients at 6 months | Comparison of the evolution of quality of life from inclusion to 6 months with the EuroQol 5 Dimensions (scale from 0 to 100; 100 being the worst outcome) | 6 months |
| Evaluating average daily analgesic consumption at inclusion. | Collection of the number and type of analgesic treatments per day for one week prior to the inclusion visit with the Medication Quantification Scale (scale from 0 to 36; 36 being the worst outcome) . | 0 month |
| Evaluating average daily analgesic consumption at 1 month | Collection of the number and type of analgesic treatments per day for one week prior to the month 1 visit with the Medication Quantification Scale (scale from 0 to 36; 36 being the worst outcome) . | 1 month |
| Evaluating average daily analgesic consumption at 3 months | Collection of the number and type of analgesic treatments per day for one week prior to the month 3 visit with the Medication Quantification Scale (scale from 0 to 36; 36 being the worst outcome) . | 3 month |
| Evaluating average daily analgesic consumption at 6 months | Collection of the number and type of analgesic treatments per day for one week prior to the month 6 visit with the Medication Quantification Scale (scale from 0 to 36; 36 being the worst outcome) . | 6 month |