The research activity of our team mainly focused on tecnical aspects to improve outcome and safety in pain therapy.
Neuromodulation RELIEF STUDY (A7007), a global registry to evaluate long-term effectiveness of neurostimulation therapy for pain.
Lead investigator: P. Maino.
Sponsor: Boston Scientific International SA.
Intrathecal pump refill: reservoir fill port identification by palpation versus ultrasound, a mono-centre prospective comparison study in patients undergoing regular intrathecal pump refill.
Lead investigator: P. Maino, E. Koetsier.
Intrathecal drug therapy with implantable intrathecal pumps is being utilized increasingly for the treatment of chronic refractory pain and spasticity. However, performing the regular refill procedures of the pumps with the commonly performed “blind” technique carries the potential risk of medication injection into the subcutaneous tissue, which can lead to an overdose. The primary purpose of this study is to assess the accuracy of the ultrasound-guided technique for the refill procedure compared to the blind technique in subjects undergoing regular refills of their intrathecal pumps for the treatment of chronic non-malignant pain or spasticity.
Dorsal root ganglion stimulation for the management of painful intractable non-diabetic small fibre neuropathy in the lower limbs: a prospective case series.
Lead investigators: P. Maino, E. Koetsier, C.Gobbi, A. Kaelin.
Background: small fiber neuropathy (SFN) is a disorder of the peripheral nerves that affects thinly myelinated A Delta and unmyelinated C nerve fibers whose painful symptoms typically affect the limbs in a distal-to-proximal gradient. Treatment of the painful symptoms frequently fails. Spinal cord stimulation (SCS) is used to treat chronic, intractable pain when conventional therapies have failed and has been shown to be effective in patients having a variety of neuropathic pain syndromes including diabetic polyneuropathy. However, achieving good pain-paresthesia overlap of the feet is noted to be challenging with conventional spinal cord stimulation.
Spinal cord stimulation of the dorsal root ganglion (DRG-SCS) is a relatively new mode of SCS with promising results and has demonstrated pain relief for groin pain, complex regional pain syndrome and chronic, intractable neuropathic pain of the limbs and trunk. The purpose of this study is to assess the effectiveness of DRG-SCS in alleviating the painful symptoms in patients with non-diabetic small fiber neuropathy in the feet. The secondary objectives are to assess neuropathic pain components, pain and paresthesia distributions, central sensitization, efficacy of DRG-SCS on the quality of life, physical functioning, mood, global improvement, and the progression of SFN assessed by biopsy.
Comparative evaluation of clinical outcome of degenerative disc disease treated with Gelstix:a new nucleus augmentation device
Lead investigators: P. Maino, E. Koetsier, R.Perez.
Degenerative Disc Disease (DDD) is one of the most common spinal pathologies, affecting up to 10-15% of adults. The degeneration is associated with diminished water-binding capabilities of the nucleus pulpous leading to disc dehydration, volume reduction, changes in cellular activity, biomechanical changes and painful symptoms. Patients are initially treated with non-surgical pain management techniques, such as anti-inflammatory medications and physical therapy, but these treatments often provide only temporary relief. When non-surgical intervention fails, fusion or total disc arthroplasty are often prescribed, both of which are highly invasive surgeries with significant associated morbidity. Clearly, a meaningful solution for the treatment gap existing between conservative care and invasive surgical intervention is needed.
The purpose of this study is to evaluate the efficacy of treatment with the GelStix™ device in a patient population that had no benefit from conservative care. The primary objective of this study is to quantify the reduction in lumbar pain.