Condition category
Surgery
Date applied
21/03/2011
Date assigned
08/04/2011
Last edited
20/09/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jean-Pierre Van Buyten

ORCID ID

Contact details

A.Z. Nikolaas
Moerlandstraat 1
Sint Niklaas
9100
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CA2011 PROVA BE

Study information

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

Acronym

PROVA

Study hypothesis

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

Committee for Medical Ethics, A.Z. Nicholas (Commissie voor Medische Ethiek, A.Z. Nikolaas) approved on 18th March 2011

Study design

Single-centre double-blind three-period prospective randomised placebo controlled crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

1. 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 measures

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

Overall trial start date

13/04/2011

Overall trial end date

13/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

13/04/2011

Recruitment end date

13/12/2012

Locations

Countries of recruitment

Belgium

Trial participating centre

A.Z. Nikolaas
Sint Niklaas
9100
Belgium

Sponsor information

Organisation

Nevro Corporation (USA)

Sponsor details

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

Sponsor type

Industry

Website

http://www.nevro.com

Funders

Funder type

Industry

Funder name

Nevro Corporation (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes