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PREFerred Neurostimulation MODdalities - PREFMOD Study

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ClinicalTrials.gov Identifier: NCT04582721
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Dr med. Paolo Maino Viceprimario Anestesiologia, Ospedale Regionale di Lugano

Tracking Information
First Submitted Date  ICMJE July 25, 2019
First Posted Date  ICMJE October 9, 2020
Last Update Posted Date October 14, 2020
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date April 9, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2020)
back pain intensity [ Time Frame: 21 days ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
back pain intensity [ Time Frame: 21 days ]
The difference in back pain intensity between the three modalities of neurostimulation measured by Numeric Rating Scale (NRS) assessed at baseline and in the 21 days trial phase
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PREFerred Neurostimulation MODdalities - PREFMOD Study
Official Title  ICMJE PREFerred Neurostimulation MODdalities to Treat Chronic Intractable Back Pain, A 3x3 Crossover Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low-back Pain
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: CON-SCS with subcutaneous stimulation
    7 days Conventional Spinal Cord Stimulation with subcutaneous stimulation
    Intervention: Other: Implantable Neurostimulator System (Spectra WaveWriter™ Spinal Cord Stimulator System), (Boston Scientific Neuromodulation Corporation, Valencia, California (CA), USA)
  • Active Comparator: HF-SCS
    7 days High Frequency Spinal Cord Stimulation
    Intervention: Other: Implantable Neurostimulator System (Spectra WaveWriter™ Spinal Cord Stimulator System), (Boston Scientific Neuromodulation Corporation, Valencia, California (CA), USA)
  • Active Comparator: Combination Therapy
    7 days a combination of CON-SCS with subcutaneous stimulation and HF-SCS
    Intervention: Other: Implantable Neurostimulator System (Spectra WaveWriter™ Spinal Cord Stimulator System), (Boston Scientific Neuromodulation Corporation, Valencia, California (CA), USA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2020)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 9, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paolo Maino 0041918119590 paolo.maino@eoc.ch
Contact: Eva Koetsier 0041918119590 eva.koetsier@eoc.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04582721
Other Study ID Numbers  ICMJE NSI-TD-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr med. Paolo Maino Viceprimario Anestesiologia, Ospedale Regionale di Lugano
Study Sponsor  ICMJE Dr med. Paolo Maino Viceprimario Anestesiologia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ospedale Regionale di Lugano
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP