PREFerred Neurostimulation MODdalities - PREFMOD Study

PREFerred Neurostimulation MODdalities to Treat Chronic Intractable Back Pain, A 3x3 Crossover Study

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Implantable Neurostimulator System (Spectra WaveWriter™ Spinal Cord Stimulator System), (Boston Scientific Neuromodulation Corporation, Valencia, California (CA), USA)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Maino, MD PhD LLM; Phone Number: 0041918119590; Email: paolo.maino@eoc.ch

Study Locations

• Switzerland
  • Ticino
    • Lugano, Ticino, Switzerland, 6900
      • Recruiting
      • Centro del Dolore, Neurocentro, Opedale Regionale di Lugano
      • Contact: Paolo Maino, MD; Phone Number: 091 811 63 37; Email: Paolo.Maino@eoc.ch
      • Contact: Eva Koetsier, MD; Phone Number: 091 81175 95

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: CON-SCS with subcutaneous stimulation; 7 days Conventional Spinal Cord Stimulation with subcutaneous stimulation	Other: 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.
ACTIVE_COMPARATOR: HF-SCS; 7 days High Frequency Spinal Cord Stimulation	Other: 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.
ACTIVE_COMPARATOR: Combination Therapy; 7 days a combination of CON-SCS with subcutaneous stimulation and HF-SCS	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
back pain intensity	The difference in the intensity of back pain between the three neurostimulation modalities as measured by the numerical rating scale (NRS) from 0 to 10, where 0 is not pain and 10 is the maximum pain the person can experience, assessed at baseline and in the trial phase 21 days	21 days

Collaborators and Investigators

• Sponsor: Ospedale Regionale di Lugano
• Collaborators: Paolo Maino MD PhD, Sponsor Investigator

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ANTICIPATED): April 9, 2022
• Study Completion (ANTICIPATED): April 30, 2023

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (ACTUAL): October 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: NSI-TD-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No