Back pain - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

Stimwave Technologies

Recruitment countries:

Netherlands, United Kingdom

Health condition studied:

Chronic Low Back Pain

URL:

Link to the clinical trial website

About the trial

Interventions:

Device: Freedom Spinal Cord Stimulator System

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  - Appropriate Freedom SCS candidate as affirmed by study investigator
  
  - Candidate has a stable spine not suitable for further surgery as confirmed by
  physician
  
  - 18 years of age or older (no upper age limit)
  
  - Diagnosis of failed back surgery syndrome (FBSS) characterized by chronic,
  intractable pain of the legs, back, or both legs and back
  
  - At least 6 months since last surgical procedure on the spine
  
  - Average score of 60mm or greater on a VAS scale (Scale of 0 to 100, where 0 equals no
  pain and 100 equals worst possible pain)
  
  - Pain duration of at least 6 months
  
  - Expected lifespan of at least two years
  
  - Able to comply with study requirements
  
  - Gives informed consent for study participation
  
  Exclusion Criteria:
  
  - A consistent VAS score of 100 over the past 24 hours as established at Visit 1
  
  - A co-existing condition that could increase the risk of SCS implantation (e.g.,
  severe cardiac or respiratory disorders, coagulation disorder) or planned surgery
  within the study duration that could be compromised by SCS (e.g., diathermy)
  
  - Pregnant or planning to become pregnant
  
  - Known or suspected substance abuse within the last 2 years
  
  - Major psychiatric disorder (untreated or refractory to treatment) in the
  investigators opinion
  
  - Cognitive and/or behavioral issues that could impair study participation, (e.g.,
  unreliability; defective memory; noncompliance in taking medications or keeping
  appointments; or impaired orientation to time, place, and events)
  
  - Documented allergy to Freedom SCS material components
  
  - Co-existing pain condition or participation in another clinical study that could
  confound the results of this study
  
  - History of another implanted medical device (e.g., explanted spinal cord stimulator,
  peripheral nerve stimulation, sacral nerve stimulator, pacemaker, or intrathecal drug
  delivery)
  

• Age minimum: 18 Years
• Age maximum: N/A
• Gender: All

Primary outcomes:

Incidence and severity of device related adverse events during the study.
Percentage of pain relief experienced in the area of pain identified at baseline compared to 12 months post full implant of the Freedom SCS system.

Secondary outcomes:

Improved quality of life function via the ODI and EQ-5D questionnaires
Improved work status.
Patient satisfaction with treatment.
Reduced operating theater time
Reduced skin to fluoroscope time
Reduced skin to skin time
Reduced visits to health care institutes for chronic back and leg pain.
Reduction in use of analgesics
To assess compliance data to indicate usability of the device.
To assess the implanters' experience with the device.
To monitor non-device and non-SCS-related adverse events

Target sample size:

45

Study type:

Interventional

Study design:

Contacts:

• Name: Frank D De Loos
• Address:
• Phone:
• Email:
• Affiliation: Amphia ziekenhuis Oosterhout

• Name: Juliette Mouws
• Address:
• Phone:
• Email: JMouws@Amphia.nl
• Affiliation:

• Name: Niek Vanquathem
• Address:
• Phone: 0032 492 69 22 23
• Email: niek@freedomneuro.com
• Affiliation:

Technical details

Scientific title:

A Prospective, Multi-National, Post-Marketing Study of the Clinical Outcomes of Wireless Neuromodulation Via the Freedom Spinal Cord Stimulation (SCS) System for the Management of Chronic Back and Leg Pain

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Amphia ziekenhuis, Oosterhout, The Netherlands

Main ID:

NCT02403518

Secondary ID:

05-0071

Register:

ClinicalTrials.gov

Date of registration:

23/03/2024

Date of first enrollment:

October 2016

Last refreshed:

3 April 2024