Clinical trial NCT05398003: Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)
Official title: Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Intractable
Keywords: Medullary stimulation
refractory neck pain
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria:

* 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
* A negative pregnancy test for women of childbearing potential
* Women of childbearing potential must use an appropriate contraceptive method(s) during the clinical trial

Non-inclusion criteria:

* Drug or alcohol abuse
* Any medical or psychological problem that may interfere with the proper conduct of the study protocol (e.g., cancer with limited life expectancy)
* Difficulty with follow-up
* Pregnant or breastfeeding women
* Women of childbearing potential who are not using contraception
* Adults under legal protection (guardianship, curatorship, "sauvegarde de justice") or deprived of liberty
* Exclusion period for another study
* Participation in another interventional study whose primary objective is based on pain.

Exclusion criteria:

- 7-day post-implantation test phase negative

Primary outcomes:
measure: Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode.
timeFrame: 6 Months
measure: Evaluating the overall satisfaction with the stimulation mode
timeFrame: 6 Months
measure: Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode.
timeFrame: 6 Months
Secondary outcomes:
measure: Evaluating the non-inferiority of patient pain with the combined mode compared to the low frequency reference mode
timeFrame: 6 Months
measure: Evaluating the non-inferiority of patient satisfaction with their overall comfort
timeFrame: 6 Months
measure: Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference mode.
timeFrame: 6 Months
measure: Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + burst vs Low frequency
timeFrame: 6 Months
measure: Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + high frequency vs Low frequency
timeFrame: 6 Months
measure: Evaluating the superioty of pain reduction with the combined mode (low frequency + high frequency) compared to the tonic mode (low frequency) only
timeFrame: 6 Months
measure: Evaluating the superioty of pain reduction with the combined mode (low frequency + Burst) compared to the tonic mode (low frequency) only
timeFrame: 6 Months
measure: 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
timeFrame: 6 Months
measure: 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
timeFrame: 6 Months
measure: Comparison of the number of recharges of the device according to the stimulation modes
timeFrame: 6 Months
measure: Evaluating the change in the quality of life of patients at 1 month
timeFrame: 1 month
measure: Evaluating the change in the quality of life of patients at 1 month
timeFrame: 1 month
measure: Evaluating the change in the quality of life of patients at 3 months
timeFrame: 3 months
measure: Evaluating the change in the quality of life of patients at 3 months
timeFrame: 3 months
measure: Evaluating the change in the quality of life of patients at 6 months
timeFrame: 6 months
measure: Evaluating the change in the quality of life of patients at 6 months
timeFrame: 6 months
measure: Evaluating average daily analgesic consumption at inclusion.
timeFrame: 0 month
measure: Evaluating average daily analgesic consumption at 1 month
timeFrame: 1 month
measure: Evaluating average daily analgesic consumption at 3 months
timeFrame: 3 month
measure: Evaluating average daily analgesic consumption at 6 months
timeFrame: 6 month
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References: