Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Nantes University Hospital
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Patients will only know the stimulation modes
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Study population
12 patients with neck and upper limb pain who have failed multidisciplinary treatment and are candidates for cervical medullary stimulation will be included.
Intervention: Implantation of the WAVEWRITER ALPHA ™ device (Device)
Outcomes
Primary Outcomes
Evaluating the non-inferiority of pain reduction with the combined mode compared to the low frequency reference mode.
Time Frame: 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
Time Frame: 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.
Time Frame: 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 Outcomes
- Evaluating the change in the quality of life of patients at 1 month(1 month)
- Evaluating the change in the quality of life of patients at 3 months(3 months)
- Evaluating the change in the quality of life of patients at 6 months(6 months)
- Evaluating the non-inferiority of patient pain with the combined mode compared to the low frequency reference mode(6 Months)
- Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + high frequency vs Low frequency(6 Months)
- Evaluating average daily analgesic consumption at 1 month(1 month)
- Evaluating the non-inferiority of patient satisfaction with their overall comfort with the mode low frequency + burst vs Low frequency(6 Months)
- Evaluating the superioty of pain reduction with the combined mode (low frequency + high frequency) compared to the tonic mode (low frequency) only(6 Months)
- Evaluating the non-inferiority of patient satisfaction with their overall comfort(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(6 Months)
- Evaluating the superioty of pain reduction with the combined mode compared to the low frequency reference 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(6 Months)
- Evaluating average daily analgesic consumption at inclusion.(0 month)
- Evaluating average daily analgesic consumption at 3 months(3 month)
- Evaluating the superioty of pain reduction with the combined mode (low frequency + Burst) compared to the tonic mode (low frequency) only(6 Months)
- Comparison of the number of recharges of the device according to the stimulation modes(6 Months)
- Evaluating average daily analgesic consumption at 6 months(6 month)