Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
- Conditions
- Pain, Intractable
- Interventions
- Device: Implantation of the WAVEWRITER ALPHA ™ device
- Registration Number
- NCT05398003
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
Number of centres planned : 1 (CHU Nantes)
Design : Randomized, Prospective
Planning of the study :
* Total duration: 34 months
* Recruitment period: 24 months.
* Follow-up time per patients : 7-10 months
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:
* the tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibers of the posterior cords of the spinal cord induces local paresthesias
* burst stimulation (or "burst")
* high frequency" stimulation (1000 Hz) "High frequency: HF".
* combined tonic + burst stimulation
* combined tonic + high frequency stimulation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Study population Implantation of the WAVEWRITER ALPHA ™ device 12 patients with neck and upper limb pain who have failed multidisciplinary treatment and are candidates for cervical medullary stimulation will be included.
- Primary Outcome Measures
Name Time Method Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode. 6 Months 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
Evaluating the overall satisfaction with the stimulation mode 6 Months 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
Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode. 6 Months 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.
- Secondary Outcome Measures
Name Time Method Evaluating average daily analgesic consumption at 1 month 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) .
Evaluating the non-inferiority of patient pain with the combined mode compared to the low frequency reference mode 6 Months 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.
Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + high frequency vs Low frequency 6 Months 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.
Evaluating the change in the quality of life of patients at 1 month 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)
Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + burst vs Low frequency 6 Months 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.
Evaluating the superioty of pain reduction with the combined mode (low frequency + high frequency) compared to the tonic mode (low frequency) only 6 Months 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.
Evaluating the non-inferiority of patient satisfaction with their overall comfort 6 Months 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.
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 6 Months 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.
Evaluating the change in the quality of life of patients at 3 months 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)
Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode. 6 Months 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
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 6 Months 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.
Evaluating the change in the quality of life of patients at 6 months 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)
Evaluating average daily analgesic consumption at inclusion. 0 month 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) .
Evaluating average daily analgesic consumption at 3 months 3 month 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) .
Evaluating the superioty of pain reduction with the combined mode (low frequency + Burst) compared to the tonic mode (low frequency) only 6 Months 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.
Comparison of the number of recharges of the device according to the stimulation modes 6 Months Number of recharges of the remote control during the 7 days of stimulation.
Evaluating average daily analgesic consumption at 6 months 6 month 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) .
Trial Locations
- Locations (1)
CHU de Nantes
🇫🇷Nantes, France