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

NCT01776749 | Completed DMC

• 1 other identifier: NL324.091.10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Failed Back Surgery Syndrome; Neuropathic Pain

Keywords

low back pain; failed back surgery syndrome; spinal cord stimulation; subcutaneous stimulation; peripheral nerve field stimulation

Outcome Measures

Primary Outcomes (1)

• responder rate

  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

Study Arms (3)

no SubQ

NO INTERVENTION

No subcutaneous leads due to adequate low back stimulation by only SCS. Patient not randomised

SubQ ON

ACTIVE COMPARATOR

Subcutaneous stimulation on

Device: SubQ

SubQ OFF

SHAM COMPARATOR

subcutaneous leads implanted, but no stimulation

Device: SubQ

Interventions

SubQ DEVICE

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.

Also known as: The octad lead (3877)SubQ leads (3888), (Prime Advanced 37702 or Restore Advanced 37713), all Medtronic

SubQ OFF; SubQ ON

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SubQ: lead
• Radboud University Medical Center: collaborator
• Albert Schweitzer Hospital: collaborator
• Maastricht University Medical Center: collaborator
• Rijnstate Hospital: collaborator
• Rijnland Hospital: collaborator
• Medtronic: collaborator
• Sint Maartenskliniek: collaborator
• Diakonessenhuis locatie Zeist: collaborator

Study Sites (1)

Albert Schweitzer hospital

Dordrecht, South Holland, 3300 AK, Netherlands

Location

Related Publications (1)

• van Heteren EPZ, van Roosendaal BWP, van Gorp EJAA, Bronkhorst EM, Kallewaard JW, Wegener JT, Burger K, Teernstra OPM, Buschman HPJ, Hamm-Faber TE, Vissers KCP. Spinal Cord Stimulation With Additional Peripheral Nerve/Field Stimulation Versus Spinal Cord Stimulation Alone on Back Pain and Quality of Life in Patients With Persistent Spinal Pain Syndrome. Neuromodulation. 2023 Apr;26(3):658-665. doi: 10.1016/j.neurom.2021.11.010. Epub 2022 Jan 26.

  PMID: 35088732 DERIVED

MeSH Terms

Conditions

Low Back Pain; Failed Back Surgery Syndrome; Neuralgia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Kris CP Vissers, MD,PhD,FIPP

  Radboud University Medical Center

  STUDY CHAIR

• Eric-Jan JA van Gorp, MD

  Albert Schweitzer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 28, 2013
• Study Start: November 9, 2011
• Primary Completion: December 20, 2014
• Study Completion: July 11, 2015
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

NL (1)