Freedom Study

• Research type

  Research Study

• Full 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

• IRAS ID

  142645

• Contact name

  Ganesan Baranidharan

• Sponsor organisation

  Stimwave Technologies

• Research summary

  In this post-marketing study the commercially available CE marked Freedom Spinal Cord Stimulator (SCS) system will be assessed in the management of chronic, difficult to treat back and leg pain, secondary to failed back surgery syndrome (FBSS). The study will assess the clinical outcomes including pain relief experienced, incidence and severity of device and implant procedures and technical failure of the electrode or the external pulse generator. Assessments will also be made on the use-ability of the system from both an implanters perspective as well as the patients’. Furthermore this study will evaluate patient satisfaction with treatment, utilisation of healthcare facilities for chronic back and leg pain post implant, work status, quality of life through validated questionnaires, and use of pain medications following implant.

  A total of 45 patients in 2 UK sites and 3 European sites will be invited to participate. These patients will have already been indentified as candidates for spinal cord stimulation for their chronic back and/or leg pain. Patients will attend the hospital for 9 visits over a period of 15-16 months. Each patient will be screened for suitability following receiving study information by the research nurse. If the patient is interested in the study they will attend clinic for baseline assessments. The patient will then be listed for a trial implant lead for a period of 7 to a maximum of 28 days to assess if SCS helps the patients pain. The trial SCS will be evaluated by the investigator with the patient and if successful will proceed to permanent implant. Once the permanent implant is completed the patient will be followed up in clinic at 6 weeks, 3, 6, 9 and finally 12 months as per standard clinical care. At these visits SCS programming and quality of life and function assessments will take place.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  14/YH/0011

• Date of REC Opinion

  28 Mar 2014

• REC opinion

  Further Information Favourable Opinion