Senza™ spinal cord stimulation system for the treatment of chronic back and leg pain in failed back surgery syndrome (FBSS) patients

ISRCTN ISRCTN33292457
DOI https://doi.org/10.1186/ISRCTN33292457
Secondary identifying numbers CA2011 PROVA BE
Submission date
21/03/2011
Registration date
08/04/2011
Last edited
20/09/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jean-Pierre Van Buyten
Scientific

A.Z. Nikolaas
Moerlandstraat 1
Sint Niklaas
9100
Belgium

Study information

Study designSingle-centre double-blind three-period prospective randomised placebo controlled crossover study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleDouble-Blind, randomised, placebo-controlled clinical trial of the Senza™ spinal cord stimulation system for the treatment of chronic back and leg pain in failed back surgery syndrome (FBSS) patients
Study acronymPROVA
Study objectivesTo characterise the effectiveness of the Senza™ System in FBSS patients naive to spinal cord stimulation (SCS)

As of 13/09/2011 the anticipated end date for this trial has been extended from 13/04/2012 to 13/12/2012 and the study design has been updated. The previous study design was as follows: 'Single-centre double-blind two-period prospective randomised placebo controlled crossover study'.
Ethics approval(s)Committee for Medical Ethics, A.Z. Nicholas (Commissie voor Medische Ethiek, A.Z. Nikolaas) approved on 18th March 2011
Health condition(s) or problem(s) studiedChronic back and leg pain in failed back surgery syndrome (FBSS) patients
InterventionSubjects who meet screening criteria will receive a permanent SCS implant and randomised to:
1. ON arm for first period/OFF arm for second period or
2. OFF arm for first period/ON arm for second period

Each blinded period will last 2 months with a 2 week washout between periods.

Added 13/09/2011:
3. Immediately following period 2, all subjects will have therapy turned ON for a 6 month open label period
Intervention typeProcedure/Surgery
Primary outcome measure1. Visual Analogue Scale (VAS) score for back pain: measured at baseline, the mid-point and end of each period
2. Emergent adverse events
Secondary outcome measures1. VAS score for leg pain: measured at baseline, the mid-point and end of each period
2. Sleep disturbance: measured at baseline, the mid-point and end of each period
3. Oswestry Disability Index: measured at baseline and the end of each period
4. Subject diary: measured at baseline, prior to mid-point and end of each period, following wash-out
5. Subject's assessment of group assignment: measured at the end of each period
6. Changes in medication usage: measured at baseline, the mid-point and end of each period
Overall study start date13/04/2011
Completion date13/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteria1. An adult (at least 18 years of age)
2. Capable of giving informed consent
3. An appropriate candidate for implantation of a spinal cord stimulator
4. Able to comply with the requirements of the study visits and self-assessment questionnaires
5. On stable pain medications for at least 4 weeks prior to the baseline visit
6. A failed back surgery syndrome (FBSS) patient with back pain intensity of at least 5 cm out of 10 cm, with radiating pain that originates from lumbar, L3, L4, L5, and/or S1
Key exclusion criteria1. Progressive neurological disease (multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, cauda equina syndrome, and herniated nucleus pulposis causing progressive motor deficit etc.) as manifested by an unstable neurologic condition
2. Has significant pain in other areas that is not intended to be treated with SCS and that could interfere with accurate pain reporting, as determined by the Investigator
3. Significant mechanical instability as determined by the Investigator
4. Pain intensity of always 10 on a 0-10 scale over the past 6 months based on subject recall
5. Metastatic malignant disease or active local malignant disease
6. A life expectancy of less than 1 year
7. A systemic infection or local infection that would contraindicate SCS placement
8. A female of child bearing potential who is pregnant/lactating or not using adequate birth control
9. Evidence of an active disruptive psychological/psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator
10. Addiction to any of the following: illicit drugs, alcohol (5 or more drinks/day) and/or medication
11. Bleeding diathesis such as coagulopathy or thrombocytopenia
12. Immunocompromised and at risk for infection
13. Diabetic
14. Unresolved issue of secondary gain
Date of first enrolment13/04/2011
Date of final enrolment13/12/2012

Locations

Countries of recruitment

  • Belgium

Study participating centre

A.Z. Nikolaas
Sint Niklaas
9100
Belgium

Sponsor information

Nevro Corporation (USA)
Industry

4040 Campbell Avenue
Suite 210
Menlo Park, CA
94025
United States of America

http://www.nevro.com
ROR logo https://ror.org/02xcxe208

Funders

Funder type

Industry

Nevro Corporation (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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