Subcutaneous Stimulation as Add on Therapy to SCS toTreat Low Back Pain in FBSS (SubQ)

January 5, 2020 updated by: SubQ

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim of the study FBSS is a clinical entity consisting of chronic leg and /or back pain due to radicular nerve damage. The effectiveness of 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.

Study design and duration of the study The study is a randomized controlled trial. Patients with FBSS with additional chronic back pain and an intensity of 5 or more for leg and back pain separately on the visual analogue scale are eligible for the study. About ninety patients will receive a SCS system targeting to relief leg and back pain. The study group consists of patients having a pain reduction of ≥50% in the leg after SCS trial stimulation. If, after trial stimulation, there is less than 50% back pain relief compared with initial values, patients will receive one or two Quad leads subcutaneously at the time of implantation of the pulse generator.

This group, a total of 56 patients,will be randomized in a 1:1 ratio in which group 1 (n=28) receives SCS plus non-activated SubQ(SubQ OFF) and group 2 (n=28) receives SCS plus activated SubQ (SubQ ON) (phase 1), for a period of 3 months.

After the controlled phase of the study, all 56 patients will receive maximal effective SCS and SubQ for the rest of the study duration (phase 2).

Total duration of the study for a patient is12 months. Estimated duration of the study is 18 months.

Comparisons will be made after 3 months between no SubQ OFF and SubQ ON. After 6 and 12 months (phase 2) patients will be compared with their baseline values to explore long term effects of SCS and SubQ.

Type and number of patients The study will include FBSS patients with leg and low back pain, failing to relief back pain with SCS. For the controlled part of the study 56 patients are needed based on a power calculation in which a difference between the two treatments is postulated of about 40%. To assure this about 90 patients will be included in the study.

Inclusion criteria Male/female > 18 and < 75 years Chronic neuropathic pain secondary to FBSS Pain radiating in lumbar segments L4 and/or L5 and/or S1 for at least 6 months Pain intensity assessed by VAS ≥ 5 scored separately for leg and back Willing to provide informed consent Exclusion criteria Presence of any other clinically significant or disabling chronic pain condition Expected inability of patients to properly operate the neurostimulation system History of coagulation disorders, lupus erythematosus, diabetes mellitus, rheumatoid arthritis or morbus Bechterew Active malignancy Current use of medicines 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 Life expectancy of less than 1 year Existing or planned pregnancy Study therapy test therapy: Adequate subcutaneous stimulation with perceived paresthesias in the painful area in the back reference therapy: SCS plus non-activated SubQ (SubQ OFF) Parameters for evaluation of effectiveness primary outcome: 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.

secondary outcomes:

Effect of SCS plus activated SubQ and SCS without activated SubQ after 3, 6 and 12 months on:

Mean reduction in pain intensity for leg and back pain separately, assessed by the VAS Responder rate of SCS on leg pain assessed by the VAS Responder rate of SubQ on back pain assessed by the VAS(after 6 and 12 months) Quality of life assessed by Short Form 36 (SF-36) Quality of life as assessed by EuroQuol (EQ-5D) Function assessed by the Oswestry disability index Patient satisfaction assessed by the Global Impression of Change (GPIC) Pain assessed by the McGill questionnaire Concomitant drug treatment for relief of pain Concomitant need for physical therapy or other non-drug treatment. Employment status Frequency and nature of adverse events

And in addition after 12 months of stimulation, on:

Cost-utility Preferred stimulation settings

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid Holland
      • Dordrecht, Zuid Holland, Netherlands, 3300 AK
        • Albert Schweitzer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
responder rate
Time Frame: 3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SubQ

Collaborators

Radboud University Medical Center
Maastricht University Medical Center
Medtronic
Albert Schweitzer Hospital
Sint Maartenskliniek
Rijnstate Hospital
Rijnland Hospital
Diakonessenhuis locatie Zeist

Investigators

  • Study Chair: Kris CP Vissers, MD,PhD,FIPP, Radboud University Medical Center
  • Principal Investigator: Eric-Jan JA van Gorp, MD, Albert Schweitzer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2011

Primary Completion (Actual)

December 20, 2014

Study Completion (Actual)

July 11, 2015

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 5, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL324.091.10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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