A pragmatic randomised prospective multi-centre non-inferiority trial in chronic pain patients with closed-loop spinal cord stimulation (CL-SCS) to compare the clinical effectiveness and cost utility of an all-in-one procedure with an at-home screening trial

A pragmatic randomised prospective multi-centre non-inferiority trial in chronic pain patients with closed-loop spinal cord stimulation (CL-SCS) to compare the clinical effectiveness and cost utility of an all-in-one procedure with an at-home screening trial - All-in-one

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57569

Enrollment

180

Registered

2025-04-18

Start date

2025-07-01

Completion date

Unknown

Last updated

2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behandeling van chronische pijn met spinal cord stimulatie chronic pain neuropathic pain

Interventions

The intervention in this trial is the randomisation to one of the two groups, TG or NTG. Patients randomised to the at-home screening trial (TG) will undergo the two procedures according to routine

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with chronic, neuropathic pain with an approved aetiology in the Netherlands: - PSPS (persistent spinal pain syndrome) - PDN (painful diabetic neuropathy) - CRPS (complex regional pain syndrome) - SFN (small fibre neuropathy) 2. Suitable candidate according to the inclusion criteria of the Dutch *Standpunt Neuromodulatie bij chronische pijn* - Adult patients >=18 years - Chronic pain >=6 months - Pain intensity of >=50mm or >=5 on VAS- or NRS-score respectively 3. Routinely selected for CL-SCS 4. Be willing to complete additional trial related questionnaires 5. Be willing and capable of giving informed consent.

Exclusion criteria

Exclusion criteria: 1. General exclusion criteria according to the Dutch *Standpunt Neuromodulatie bij chronische pijn*: - Drug abuse - Pregnancy - Coagulation disorder / Use of anticoagulation therapy which cannot be stopped temporarily - Active infection - Life expectation

Design outcomes

Primary

Measure	Time frame
Pain intensity at six months post-implant.	—

Secondary

Measure	Time frame
Costs: iMCQ, iPCQ and EQ-5D-5L index for QALY PROMs: - Holistic responders - Pain medication and opioid use - Pain reduction (NRS) - Health related quality of life (SF-12, EQ-5D-5L, PROMIS-GH, PROMIS-29 short form) - Physical functioning (BPI, ODI) - Emotional functioning (HADS, PCS) - Sleep (PSQI) - Global improvement with treatment (PGIC) - Device settings and data (e.g., ECAP target, amplitude, pulse width, frequency programmed electrodes, recharge characteristics and patient usage)	—

Measure

Time frame

Costs: iMCQ, iPCQ and EQ-5D-5L index for QALY PROMs: - Holistic responders - Pain medication and opioid use - Pain reduction (NRS) - Health related quality of life (SF-12, EQ-5D-5L, PROMIS-GH, PROMIS-29 short form) - Physical functioning (BPI, ODI) - Emotional functioning (HADS, PCS) - Sleep (PSQI) - Global improvement with treatment (PGIC) - Device settings and data (e.g., ECAP target, amplitude, pulse width, frequency programmed electrodes, recharge characteristics and patient usage)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)