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.
Verified June 2011 by SubQ
Sponsor:
SubQ
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
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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:
|
|
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:
|
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
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 May 23, 2013