Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of chronic back and leg pain. Additionally, a subgroup analysis will be performed to evaluate potential differences between paddle/surgical leads versus percutaneous leads.
Study Type
OBSERVATIONAL
Enrollment
250
differential target multiplexed stimulation
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, Belgium
RECRUITINGZNA
Antwerp, Belgium
RECRUITINGOverall pain intensity with Visual Analogue Scale (VAS)
Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm)
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Back pain intensity with Visual Analogue Scale (VAS)
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Leg pain intensity with Visual Analogue Scale (VAS)
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Pain medication use
Open question regarding the dosage, frequency and type of pain medication
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Functional disability
The functional disabilities will be assessed with the Oswestry Disability Index (ODI)
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Health related quality of life
Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Patient global impression of change
Patients will be asked to quantify the impression of change after treatment using the Patient Global Impression of Change scale (PGIC).
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AZ Sint-Jan Brugge-Oostende
Bruges, Belgium
RECRUITINGAZ Sint-Lucas Brugge
Bruges, Belgium
RECRUITINGJessa Ziekenhuis
Hasselt, Belgium
RECRUITINGAZ Groeninge
Kortrijk, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGHeilig Hart Ziekenhuis Lier
Lier, Belgium
RECRUITINGCentre Hospitalier Régional (CHR) de la Citadelle
Liège, Belgium
RECRUITINGAZ Sint-Maarten
Mechelen, Belgium
RECRUITING...and 4 more locations
Time frame: Evaluated at 1 month, 6 months and 12 months of DTM SCS.
Clinical holistic responder status
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Patients' individual competencies for self-management
Patient activation measure-13 (PAM) is a 13-item instrument which assesses self-reported behaviour, knowledge, and confidence for self-management of one's health.
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Work status
Work status is evaluated with a self-designed questionnaire
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Pain catastrophizing
The Pain Catastrophizing Scale (PCS) will be used to measure the level of pain catastrophizing
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Symptoms of central sensitisation.
The Central Sensitization Inventory is used to measure symptoms of central sensitisation
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Anxiety and Depression.
The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Healthcare utilisation.
Postoperative healthcare expenditure will be investigated by self-reporting methods.
Time frame: The change between implantation and evaluation at 1 month, 6 months and 12 months of DTM SCS
Time spent in body postures
Based on the AdaptiveStim technology, the time spent in body postures can be recorded.
Time frame: The data will be extracted from SCS implantation up to 1 month of SCS, from 1 month of SCS up to 6 months and from 6 months up to 12 months
(Serious) adverse events
Systematically recording all adverse events
Time frame: Throughout study period
Proportion of successful DTM trials.
Time frame: Evaluated after final SCS implantation
Battery consumption
Time frame: Registration at 1 month, 6 months and 12 months of DTM SCS
Prevalence of technical issues with regard to DTM SCS programming
Time frame: Throughout study period
DTM SCS stimulation parameters
Time frame: Registration at 1 month, 6 months and 12 months of DTM SCS
Patient expectations concerning SCS
Self-constructed open question to evaluate patient expectations about SCS
Time frame: Evaluated at baseline visit