PREFerred Neurostimulation MODdalities - PREFMOD Study

• ClinicalTrials.gov Identifier: NCT04582721
• Recruitment Status: Recruiting
• First Posted: October 9, 2020
• Last Update Posted: March 26, 2021
• Sponsor: Ospedale Regionale di Lugano
• Collaborator: Paolo Maino MD PhD, Sponsor Investigator
• Information provided by (Responsible Party): Eva Koetsier MD PhD LLM, Ospedale Regionale di Lugano

Tracking Information

• First Submitted Date: July 25, 2019
• First Posted Date: October 9, 2020
• Last Update Posted Date: March 26, 2021
• Actual Study Start Date: April 1, 2019
• Estimated Primary Completion Date: April 9, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PREFerred Neurostimulation MODdalities - PREFMOD Study
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Low-back Pain

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 5, 2020): 18
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2023
• Estimated Primary Completion Date: April 9, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Eva Koetsier, MD PhD LLM; 0041918119590; eva.koetsier@eoc.ch

Contact: Paolo Maino, MD PhD LLM; 0041918119590; paolo.maino@eoc.ch

• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT04582721
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Eva Koetsier MD PhD LLM, Ospedale Regionale di Lugano
• Study Sponsor: Ospedale Regionale di Lugano
• Collaborators: Paolo Maino MD PhD, Sponsor Investigator
• Investigators: Not Provided
• PRS Account: Ospedale Regionale di Lugano
• Verification Date: March 2021