Subcutaneous Stimulation as Add on Therapy to Spinal Cord Stimulation (SCS) to Treat Low Back Pain in Failed Back Surgery Syndrome (FBSS) (SubQ Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by SubQ
Sponsor:
Collaborators:
Radboud University
Albert Schweitzer Hospital
Maastricht University Medical Center
Rijnstate Hospital
Rijnland Ziekenhuis
Medtronic
Sint Maartenskliniek
Diakonessenhuis locatie Zeist
Information provided by (Responsible Party):
SubQ
ClinicalTrials.gov Identifier:
NCT01776749
First received: January 23, 2013
Last updated: January 25, 2013
Last verified: June 2011
  Purpose

Aim of the study Failed back surgery syndrome (FBSS) is a clinical entity consisting of chronic leg and /or back pain due to radicular nerve damage. The effectiveness of Spinal Cord Stimulation (SCS) in the pain management of patients with FBSS is proven. Patients mostly have dominant leg pain, however a significant percentage of FBSS patients has a more pronounced back pain and are commonly excluded from SCS as it is often inadequate in relieving both the back and leg pain components. Recently some reports showed the benefit of subcutaneous stimulation (SubQ) for low back pain in patients with FBSS. This has been confirmed by a feasibility study performed by our group. The aim of the randomized controlled study is to evaluate the effect of SubQ on low back pain in FBSS patients for whom SCS gives an inadequate back pain relief.

Hypothesis We hypothesize that SubQ in addition to SCS in FBSS patients with leg and low back pain is more effective in treating low back pain (i.e. >50% pain reduction) than SCS alone.


Condition Intervention
Low Back Pain
Failed Back Surgery Syndrome
Neuropathic Pain
Device: SubQ

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Subcutaneous Stimulation as Add on Therapy to SCS to Treat Low Back Pain in FBSS

Resource links provided by NLM:


Further study details as provided by SubQ:

Primary Outcome Measures:
  • responder rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The proportion of patients with SCS plus activated SubQ and SCS without activated SubQ having 50% or more pain relief(responder rate) in back after 3 months of stimulation, assessed with the VAS


Estimated Enrollment: 90
Study Start Date: December 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no SubQ
No subcutaneous leads due to adequate low back stimulation by only SCS. Patient not randomised
Active Comparator: SubQ ON
Subcutaneous stimulation on
Device: SubQ
Spinal Cord Stimulation (SCS) and subcutaneous (SubQ) stimulation SCS trial stimulation: Implantation of the Octad lead in the epidural space. The lead implantation in the epidural space is performed under local anesthesia using a standard percutaneous technique. A key element to the technical success of an SCS procedure is the accurate placement of the lead, which results in paresthesia covering the patients' painful areas. This depends on the patients' feedback during intra-operative testing. Therefore, it is important that the patient is awake and fully cooperative during the trial stimulation.
Other Names:
  • The octad lead (3877)SubQ leads (3888)
  • (Prime Advanced 37702 or Restore Advanced 37713)
  • all Medtronic
Sham Comparator: SubQ OFF
subcutaneous leads implanted, but no stimulation
Device: SubQ
Spinal Cord Stimulation (SCS) and subcutaneous (SubQ) stimulation SCS trial stimulation: Implantation of the Octad lead in the epidural space. The lead implantation in the epidural space is performed under local anesthesia using a standard percutaneous technique. A key element to the technical success of an SCS procedure is the accurate placement of the lead, which results in paresthesia covering the patients' painful areas. This depends on the patients' feedback during intra-operative testing. Therefore, it is important that the patient is awake and fully cooperative during the trial stimulation.
Other Names:
  • The octad lead (3877)SubQ leads (3888)
  • (Prime Advanced 37702 or Restore Advanced 37713)
  • all Medtronic

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 75 years.
  • Chronic pain secondary to FBSS. Pain radiating in lumbar segments L4 and/or L5 and/or S1 for at least 6 months following at least one anatomically successful surgery.
  • Pain intensity in leg(s) and low back of 5 or higher for leg and back measured separately on a weighted visual analogue scale (VAS).
  • Previous treatment has been unsuccessful (insufficient pain relief and/or unacceptable side-effects).
  • Willing to provide informed consent.

Exclusion Criteria:

  • Exclusion criteria
  • Presence of any other clinically significant or disabling chronic pain condition
  • Expected inability of the patient to properly operate the neurostimulation system
  • History of coagulation disorders, lupus erythematosus, diabetes mellitus, rheumatoid arthritis or morbus Bechterew
  • Current use of medication affecting coagulation which cannot be temporarily stopped
  • Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
  • The patient has ever had SCS
  • Addiction: drugs, alcohol (>5 U / day) and/or medication
  • Insufficient cooperation from the patient (little motivation, understanding or communication)
  • Immune deficiency (HIV-positive, corticosteroids with a dose equivalent to

    • prednisolone 10 mg, immunosuppressives, etc.)
  • Life expectancy < 1 year
  • Pacemaker
  • Local infection or other skin disorders at site of incision
  • Existing or planned pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776749

Contacts
Contact: Eric-Jan JA van Gorp, MD +31644736220 e.j.van.gorp@asz.nl

Locations
Netherlands
Albert Schweitzer hospital Recruiting
Dordrecht, Zuid Holland, Netherlands, 3300 AK
Contact: Eric-Jan J.A. van Gorp, MD    +31644736220    e.j.van.gorp@asz.nl   
Principal Investigator: Kris C.P. Vissers, MD, PhD, FIPP         
Sponsors and Collaborators
SubQ
Radboud University
Albert Schweitzer Hospital
Maastricht University Medical Center
Rijnstate Hospital
Rijnland Ziekenhuis
Medtronic
Sint Maartenskliniek
Diakonessenhuis locatie Zeist
Investigators
Study Chair: Kris CP Vissers, MD,PhD,FIPP Radboud University
Principal Investigator: Eric-Jan JA van Gorp, MD Albert Schweitzer Hospital
  More Information

No publications provided

Responsible Party: SubQ
ClinicalTrials.gov Identifier: NCT01776749     History of Changes
Other Study ID Numbers: NL324.091.10
Study First Received: January 23, 2013
Last Updated: January 25, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by SubQ:
low back pain
failed back surgery syndrome
spinal cord stimulation
subcutaneous stimulation
peripheral nerve field stimulation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neuralgia
Failed Back Surgery Syndrome
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014