Failed Back Surgery Syndrome, Failed Neck Surgery Syndrome, Persistent Spinal Pain Syndrome Type 2
Conditions
Brief summary
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of Persistent Spinal Pain Syndrome Type II (PSPS-T2). Identification of clinical effective parameters concerning frequency, pulse duration, amplitude and battery consumption/recharge frequency and safety evaluation.
Interventions
DEVICESpinal Cord Stimulation
Differential target multiplexed stimulation
Sponsors
Universitair Ziekenhuis Brussel
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* having chronic pain as a result of PSPS-T2 that exists for at least 6 months with at least moderate pain intensity (4 or higher measured on numeric rating scale (NRS) or 31mm or higher measured on visual analogue scale (VAS) for the dominant pain location. * being offered treatment with DTM SCS * being at least 18 years old
Exclusion criteria
* Expected inability of patients to properly operate the SCS system * History of coagulation disorders, lupus erythematosus, diabetic neuropathy * Active malignancy * Addiction to drugs and/or alcohol (more than 5 units /day) * Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to complete questionnaires, as determined by the investigator * Immune deficiency (e.g. HIV positive, immunosuppressiva) * Life expectancy \< 1 year * Local infection or other skin disorder at site of incision * Pregnancy * Other implanted active medical device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall pain intensity | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | The primary effectiveness outcome measure is pain intensity measured with the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (maximal pain) in electronic format. Two scales will be presented for low back/neck pain and for leg/arm pain. Ecological momentary Assessment (EMA) will be used to collect pain intensity scores for VAS, whereby pain intensity is measured for multiple times per day for 1 week to reveal patterns of transient or fluctuating symptoms in the environment and context of the patients' lives, without a recall bias. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity for the lower back and leg pain or neck and arm pain component | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | Pain intensity for the lower back and leg pain or neck and arm pain component will be assessed separately with the Numeric Rating Scale (0 to 10). Pain intensity for the last 7 days will be assessed in electronic format, with and without medication use. |
| Medication use | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | Open question regarding the use of medication (collected through ecological momentary assessment for 1 week). |
| Negative affect | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | Questions on a 9-point scale for negative affects, evaluated through ecological momentary assessment for 7 days. |
| Functional disability | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | The Oswestry disability index (ODI; 0 to 100) or Neck disability index (NDI; 0 to 100) is used to measure functional disability due to abnormalities of the spine |
| Health related quality of life | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels |
| Patient global impression of change | Evaluated at 1 month, 6 months and 12 months of DTM SCS | Patients will be asked to quantify the impression of change after treatment using the Patient Global Impression of Change scale (PGIC) |
| Clinical holistic responder status | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | This is a composite measure for success, relying on the combination of the above questionnaires. |
| Work status | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | Work status is evaluated with a self-designed questionnaire |
| Pain catastrophizing | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | The Pain Catastrophizing Scale (PCS) will be used to measure the level of pain catastrophizing |
| Anxiety and Depression | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression |
| Patient expectations concerning SCS | Evaluated at baseline visit | Self-constructed open question to evaluate patient expectations about SCS |
| Patient unwanted stimulation awareness and satisfaction about the therapy | Evaluated at 1 month, 6 months and 12 months of DTM SCS | investigated by self-reporting methods with 12 questions |
| Time spent in body postures | 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 | Based on the AdaptiveStim technology, the time spent in body postures can be recorded |
| (Serious) adverse events | Throughout study period, an average of 1 year | Systematically recording all adverse events |
| Proportion of successful DTM trials | Evaluated after final SCS implantation | — |
| Technical IPG details (ECAPs etc.) | Registration at 1 month, 6 months and 12 months of DTM SCS | Information from implantable pulse generators will be extracted. |
| DTM SCS stimulation parameters | Time Frame: Registration at 1 month, 6 months and 12 months of DTM SCS | Information from implantable pulse generators will be extracted. |
| Battery consumption | Registration at 1 month, 6 months and 12 months of DTM SCS | Information from implantable pulse generators will be extracted. |
| Prevalence of technical issues with regard to DTM SCS programming | Throughout study period, an average of 1 year | — |
| Actigraphy data | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | A Garmin Venue series watch will be used to collect actigraphy data. Devices are worn for 7 consecutive days. This data will only be collected at Belgian sites. |
Countries
Belgium, Netherlands
Contacts
CONTACTMaarten TA Moens, MD, PhD
CONTACTLisa Goudman, PT, MSc, PhD
Outcome results
None listed