Low Back Pain Clinical Trial
— SubQOfficial title:
Subcutaneous Stimulation as Add on Therapy to Spinal Cord Stimulation (SCS) to Treat Low Back Pain in Failed Back Surgery Syndrome (FBSS) (SubQ Study)
Verified date | January 2020 |
Source | SubQ |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 11, 2015 |
Est. primary completion date | December 20, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Albert Schweitzer hospital | Dordrecht | Zuid Holland |
Lead Sponsor | Collaborator |
---|---|
SubQ | Albert Schweitzer Hospital, Diakonessenhuis locatie Zeist, Maastricht University Medical Center, Medtronic, Radboud University, Rijnland Hospital, Rijnstate Hospital, Sint Maartenskliniek |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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