Differential Target Multiplexed Spinal Cord Stimulation

Failed Back Surgery Syndrome Clinical Trial

— DETECT  

Official title:

Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05068011
• Other study ID #: DETECT
• Status: Recruiting
• Start date: October 6, 2021
• Est. completion date: March 2024

Study information

• Verified date: October 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: Maarten Moens, prof.dr.
• Phone: +3224775514
• Email: maarten.moens[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with severe chronic pain (> 5 on numeric rating scale, NRS) for at least 6 months due to FBSS (PSPS T2) and suitable for treatment with DTM SCS according to the treating physician

• Age > 18 years

• Patient has been informed of the study procedures and has given written informed consent

• Patient willing to comply with study protocol including attending the study visits

Exclusion Criteria:

• Expected inability of the patient to receive or properly operate the spinal cord stimulation system

• History of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or morbus Bechterew

• Active malignancy

• Addiction to drugs, alcohol (>5 units per day) and/or medication

• Evidence of an active disruptive psychiatric disorder or other known condition that may impact perception of pain, compliance to the intervention, and/or ability to evaluate treatment outcome as determined by investigator

• Immune deficiency (e.g. HIV positive, immunosuppressive treatment)

• Life expectancy < 1 year

• Local infection or any other skin disorder at site of incision

• Pregnancy

• Other implanted active medical device

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Syndrome

Intervention

Device:
• Spinal Cord Stimulation
differential target multiplexed stimulation

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Moens Maarten

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall 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)	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary	Back pain intensity with Visual Analogue Scale (VAS)		The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary	Leg pain intensity with Visual Analogue Scale (VAS)		The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary	Pain medication use	Open question regarding the dosage, frequency and type of pain medication	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary	Functional disability	The functional disabilities will be assessed with the Oswestry Disability Index (ODI)	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary	Health related quality of life	Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary	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).	Evaluated at 1 month, 6 months and 12 months of DTM SCS.
Secondary	Clinical holistic responder status		The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary	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.	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary	Work status	Work status is evaluated with a self-designed questionnaire	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary	Pain catastrophizing	The Pain Catastrophizing Scale (PCS) will be used to measure the level of pain catastrophizing	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary	Symptoms of central sensitisation.	The Central Sensitization Inventory is used to measure symptoms of central sensitisation	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary	Anxiety and Depression.	The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression	The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary	Healthcare utilisation.	Postoperative healthcare expenditure will be investigated by self-reporting methods.	The change between implantation and evaluation at 1 month, 6 months and 12 months of DTM SCS
Secondary	Time spent in body postures	Based on the AdaptiveStim technology, the time spent in body postures can be recorded.	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
Secondary	(Serious) adverse events	Systematically recording all adverse events	Throughout study period
Secondary	Proportion of successful DTM trials.		Evaluated after final SCS implantation
Secondary	Battery consumption		Registration at 1 month, 6 months and 12 months of DTM SCS
Secondary	Prevalence of technical issues with regard to DTM SCS programming		Throughout study period
Secondary	DTM SCS stimulation parameters		Registration at 1 month, 6 months and 12 months of DTM SCS
Secondary	Patient expectations concerning SCS	Self-constructed open question to evaluate patient expectations about SCS	Evaluated at baseline visit