PREFerred Neurostimulation MODdalities - PREFMOD Study
1 other identifier
interventional
18
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 25, 2019
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedMarch 26, 2021
March 1, 2021
3 years
July 25, 2019
March 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
CON-SCS with subcutaneous stimulation
ACTIVE COMPARATOR7 days Conventional Spinal Cord Stimulation with subcutaneous stimulation
HF-SCS
ACTIVE COMPARATOR7 days High Frequency Spinal Cord Stimulation
Combination Therapy
ACTIVE COMPARATOR7 days a combination of CON-SCS with subcutaneous stimulation and HF-SCS
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Psychological disorders
- Coagulation disorders
- Known immune-deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro del Dolore, Neurocentro, Opedale Regionale di Lugano
Lugano, Canton Ticino, 6900, Switzerland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD LLM
Study Record Dates
First Submitted
July 25, 2019
First Posted
October 9, 2020
Study Start
April 1, 2019
Primary Completion
April 9, 2022
Study Completion
April 30, 2023
Last Updated
March 26, 2021
Record last verified: 2021-03