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
Protocol serial number	CA2011 PROVA BE
Sponsor	Nevro Corporation (USA)
Funder	Nevro Corporation (USA)

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

Primary study design	Interventional
Study design	Single-centre double-blind three-period prospective randomised placebo controlled crossover study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Double-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 acronym	PROVA
Study objectives	To 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) studied	Chronic back and leg pain in failed back surgery syndrome (FBSS) patients
Intervention	Subjects 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 type	Procedure/Surgery
Primary outcome measure(s)	1. Visual Analogue Scale (VAS) score for back pain: measured at baseline, the mid-point and end of each period 2. Emergent adverse events
Key secondary outcome measure(s)	1. 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
Completion date	13/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Key inclusion criteria	1. 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 criteria	1. 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 enrolment	13/04/2011
Date of final enrolment	13/12/2012

Locations

Countries of recruitment

Belgium

Study participating centre

A.Z. Nikolaas

Sint Niklaas
9100
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes