Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
ConditionPain, Intractable
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNantes University Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 to 85 years
Patients with chronic neck and upper limb pain (according to HAS criteria for spinal cord stimulation)
Patients must be able to give informed consent and must have signed an informed consent
Affiliation to the health insurance
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
Implantation of the WAVEWRITER ALPHA ™ device
DeviceThe 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: * tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibres of the posterior cords of the spinal cord induces local paresthesias * high frequency" stimulation (1000 Hz) "High Frequency". * stimulation in bursts (or "Burst")
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Study populationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
6 Months2
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
Time frame
6 Months3
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.
Time frame
6 MonthsSecondary outcomes
1
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.
Time frame
6 Months2
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.
Time frame
6 Months3
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
Time frame
6 Months4
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.
Time frame
6 MonthsSponsors and contacts
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Source ClinicalTrials.gov