PREFerred Neurostimulation MODdalities - PREFMOD Study

NCT ID: NCT04582721

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2023-04-30

Brief Summary

This is a prospective 3x3 crossover study with randomized treatment order, comparing the short-term efficacy of conventional-spinal cord stimulation (CON-SCS) with subcutaneous stimulatio, high frequency-spinal cord stimulation (HF-SCS), and Combination Therapy, in patients with chronic intractable back pain (with or without leg pain).

Detailed Description

Patients will be preselected for inclusion in this study at the pain management center of Neurocenter of Southern Switzerland, Ente Ospedaliero Cantonale (EOC) Lugano, and will be informed about study-details by a study clinician. After informed consent signature, the participants with chronic intractable back or back and leg pain will be implanted with the stimulation lead(s). The leads are initially connected to an external trial neurostimulator. Patients will be implanted with two epidural leads and two subcutaneous leads. A three weeks trial phase will follow. The first two days after the leads implant will be without stimulation and thereafter alternating stimulation every week will start, randomly ordering the treatments using a Williams design balanced for first-order carryover effects (i.e. incorporating 6 different treatment orders), from:

• 1) CON-SCS with Subcutaneous stimulation
• 2) HF-SCS
• 3) Combination Therapy A patient's favored SCS mode, providing that there is at least 50% reduction in pain intensity on the NRS in the trial phase, will then be implanted and patients will be followed up for 12 months.

Pain intensity and pain medication will be assessed with a pain diary at baseline and during the trial phase and will be furthermore measured after 3, 6, and 12 months after the implantation. Physical functioning, Pain Extent, Patient Global Impression of Change (PGIC), and Satisfaction with stimulation treatment (SST) will be assessed during the trial phase and will be furthermore measured after 3, 6, and 12 months after the Implantable Nerve Stimulator (INS) implantation. The other secondary outcomes will be measured at baseline, and after 3, 6 and 12 months.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CON-SCS with subcutaneous stimulation

7 days Conventional Spinal Cord Stimulation with subcutaneous stimulation

Group Type: ACTIVE_COMPARATOR

Implantable Neurostimulator System (Spectra WaveWriter™ Spinal Cord Stimulator System), (Boston Scientific Neuromodulation Corporation, Valencia, California (CA), USA)

Intervention Type: OTHER

the participants with chronic intractable back or back and leg pain will be implanted with the stimulation lead(s). The leads are initially connected to an external trial neurostimulator. Patients will be implanted with two epidural leads and two subcutaneous leads. A three weeks trial phase will follow. The first two days after the leads implant will be without stimulation and thereafter alternating stimulation every week will start, randomly ordering the treatments using a Williams design balanced for first-order carryover effects (i.e. incorporating 6 different treatment orders), from:

• 1) CON-SCS with Subcutaneous stimulation
• 2) HF-SCS
• 3) Combination Therapy A patient's favored SCS mode, providing that there is at least 50% reduction in pain intensity on the NRS in the trial phase, will then be implanted and patients will be followed up for 12 months.

HF-SCS

7 days High Frequency Spinal Cord Stimulation

Group Type: ACTIVE_COMPARATOR

Implantable Neurostimulator System (Spectra WaveWriter™ Spinal Cord Stimulator System), (Boston Scientific Neuromodulation Corporation, Valencia, California (CA), USA)

Intervention Type: OTHER

the participants with chronic intractable back or back and leg pain will be implanted with the stimulation lead(s). The leads are initially connected to an external trial neurostimulator. Patients will be implanted with two epidural leads and two subcutaneous leads. A three weeks trial phase will follow. The first two days after the leads implant will be without stimulation and thereafter alternating stimulation every week will start, randomly ordering the treatments using a Williams design balanced for first-order carryover effects (i.e. incorporating 6 different treatment orders), from:

• 1) CON-SCS with Subcutaneous stimulation
• 2) HF-SCS
• 3) Combination Therapy A patient's favored SCS mode, providing that there is at least 50% reduction in pain intensity on the NRS in the trial phase, will then be implanted and patients will be followed up for 12 months.

Combination Therapy

7 days a combination of CON-SCS with subcutaneous stimulation and HF-SCS

Group Type: ACTIVE_COMPARATOR

Implantable Neurostimulator System (Spectra WaveWriter™ Spinal Cord Stimulator System), (Boston Scientific Neuromodulation Corporation, Valencia, California (CA), USA)

Intervention Type: OTHER

the participants with chronic intractable back or back and leg pain will be implanted with the stimulation lead(s). The leads are initially connected to an external trial neurostimulator. Patients will be implanted with two epidural leads and two subcutaneous leads. A three weeks trial phase will follow. The first two days after the leads implant will be without stimulation and thereafter alternating stimulation every week will start, randomly ordering the treatments using a Williams design balanced for first-order carryover effects (i.e. incorporating 6 different treatment orders), from:

• 1) CON-SCS with Subcutaneous stimulation
• 2) HF-SCS
• 3) Combination Therapy A patient's favored SCS mode, providing that there is at least 50% reduction in pain intensity on the NRS in the trial phase, will then be implanted and patients will be followed up for 12 months.

Interventions

Implantable Neurostimulator System (Spectra WaveWriter™ Spinal Cord Stimulator System), (Boston Scientific Neuromodulation Corporation, Valencia, California (CA), USA)

the participants with chronic intractable back or back and leg pain will be implanted with the stimulation lead(s). The leads are initially connected to an external trial neurostimulator. Patients will be implanted with two epidural leads and two subcutaneous leads. A three weeks trial phase will follow. The first two days after the leads implant will be without stimulation and thereafter alternating stimulation every week will start, randomly ordering the treatments using a Williams design balanced for first-order carryover effects (i.e. incorporating 6 different treatment orders), from:

• 1) CON-SCS with Subcutaneous stimulation
• 2) HF-SCS
• 3) Combination Therapy A patient's favored SCS mode, providing that there is at least 50% reduction in pain intensity on the NRS in the trial phase, will then be implanted and patients will be followed up for 12 months.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years or older at inclusion
• chronic, intractable back or back and leg pain during at least 6 months
• pain intensity of ≥ 5 on a NRS (ranging from 0 to 10)
• previous drug therapy unsuccessful

Exclusion Criteria

• Psychological disorders
• Coagulation disorders
• Known immune-deficiency

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paolo Maino MD PhD, Sponsor Investigator

UNKNOWN

Sponsor Role: collaborator

Ospedale Regionale di Lugano

OTHER

Sponsor Role: lead

Responsible Party

Eva Koetsier MD PhD LLM

MD PhD LLM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro del Dolore, Neurocentro, Opedale Regionale di Lugano

Lugano, Canton Ticino, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Eva Koetsier, MD PhD LLM

Role: CONTACT

eva.koetsier@eoc.ch

0041918119590

Paolo Maino, MD PhD LLM

Role: CONTACT

paolo.maino@eoc.ch

0041918119590

Facility Contacts

Paolo Maino, MD

Role: primary

Paolo.Maino@eoc.ch

091 811 63 37

Eva Koetsier, MD

Role: backup

091 81175 95

Other Identifiers

NSI-TD-010

Identifier Type: -

Identifier Source: org_study_id