Christopher A. Gilmore

A Randomized, Placebo-Controlled Trial of Transdiscal Radiofrequency, Biacuplasty for Treatment of Discogenic Lower Back Pain

OBJECTIVE The aim was to compare the efficacy of intradiscal biacuplasty (IDB) with that of placebo treatment for discogenic low back pain. DESIGN This is a randomized, placebo-controlled trial. Subjects were randomized on a 1:1 basis to IDB and sham groups. Follow-ups were conducted at 1, 3, and 6 months. Subjects and coordinators were blinded to randomization until 6 months. Of the 1,894 subjects screened, 64 subjects were enrolled, and 59 were treated: 29 randomized to IDB and 30 to sham. All subjects had a history of chronic low back pain for longer than 6 months. INTERVENTIONS Two cooled radiofrequency (RF) electrodes placed in a bipolar manner in affected discs to lesion the nociceptive fibers of the annulus fibrosus. The sham procedure was identical to the active treatment except that probes were not directly inserted into the disc space, and RF energy was not actively delivered. RESULTS The principal outcome measures were physical function, pain, disability, and opioid usage. Patients in the IDB group exhibited statistically significant improvements in physical function (P = 0.029), pain (P = 0.006), and disability (P = 0.037) at 6-month follow-up as compared to patients who received sham treatment. Treatment patients reported a reduction of 16 mg daily intake of opioids at 6 months; however, the results were not statistically different from sham patients. CONCLUSIONS The results suggest that the clinical benefits observed in this study are the result of non-placebo treatment effects afforded by IDB. IDB should be recommended to select the patients with chronic discogenic low back pain. (Clinicaltrials.gov number, NCT00750191.).

Treatment of post-amputation pain with peripheral nerve stimulation.

Present treatment methods are often unsatisfactory in reducing post‐amputation pain. Peripheral nerve stimulation (PNS) could reduce the pain, but it is rarely used because present methods require invasive surgical access and precise placement of the leads in close proximity (≤2 mm) with the nerve.

Peripheral Nerve Stimulation for the Treatment of Postamputation Pain—A Case Report

Many amputees suffer from postamputation pain, which can be extremely debilitating, decrease quality of life, increase the risk of depression, and negatively affect interpersonal relationships and the ability to work. Present methods of treatment, including medications, are often unsatisfactory in reducing postamputation pain. Electrical stimulation of the nerve innervating the painful area could reduce the pain, but peripheral nerve stimulation is rarely used to treat postamputation pain because present methods require invasive surgical access and precise placement of the leads in close proximity (≤ 2 mm) with the nerve. The present study investigated a novel approach to peripheral nerve stimulation in which a lead was placed percutaneously a remote distance (> 1 cm) away from the femoral nerve in a patient with severe residual limb pain (RLP) 33 years following a below‐knee amputation. Electrical stimulation generated ≥ 75% paresthesia coverage, reduced RLP by > 60%, and improved quality of life outcomes as measured by the pain interference scale of the Brief Pain Inventory‐Short Form (100% reduction in pain interference), Pain Disability Index (74% reduction in disability), and the Patient Global Impression of Change (very much improved) during a 2‐week home trial. There were no adverse events. The ability to generate significant paresthesia coverage and pain relief with a single lead inserted percutaneously and remotely from the target nerve holds promise for providing relief of postamputation pain.

Radiofrequency Intradiscal Biacuplasty for Treatment of Discogenic Lower Back Pain: A 12-Month Follow-Up

INTRODUCTION Discogenic low back pain (LBP) affects a considerable number of patients suffering from chronic LBP. Recently, a growing interest has emerged in minimally invasive treatment options for discogenic LBP. Intradiscal biacuplasty (IDB), which uses cooled radiofrequency technology to ablate nociceptors in the posterior aspect of the intervertebral disc, is one such option. We previously presented 6-month results of a randomized, double-blinded, sham-controlled study. Now, we present the unblinded, 12-month follow-up data for treatment patients and 6-month data for cross-over subjects from the original sham group. METHODS Physical function, pain relief, and disability were assessed using the Short Form-36, numerical rating scale, and Oswestry Disability Index, respectively. Subjects were unblinded at 6 months, and those initially randomized to sham procedure were given the option to cross over to IDB. RESULTS Twenty-two out of 27 subjects in the original active treatment group were followed until 12 months and had clinically significant improvements in physical function (Δ = 22) and pain (Δ = -2.9). Out of 30 subjects originally in the sham group, 24 chose to cross over, and 20 cross-over patients completed follow-up at 6 months. In cross-over patients, improvements in physical function and pain did not differ statistically from those of patients originally randomized to IDB treatment. No complications or adverse events related to the procedure were reported. CONCLUSIONS Clinically significant improvements after IDB initially reported at 6 months were maintained at 9 and 12 months. The cross-over subjects had similar improvement in all outcome measures at all observed time points.

Infection Rates of Electrical Leads Used for Percutaneous Neurostimulation of the Peripheral Nervous System.

Percutaneous neurostimulation of the peripheral nervous system involves the insertion of a wire “lead” through an introducing needle to target a nerve/plexus or a motor point within a muscle. Electrical current may then be passed from an external generator through the skin via the lead for various therapeutic goals, including providing analgesia. With extended use of percutaneous leads sometimes greater than a month, infection is a concern. It was hypothesized that the infection rate of leads with a coiled design is lower than for leads with a noncoiled cylindrical design.

Neurostimulation for Postsurgical Analgesia: A Novel System Enabling Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation

While neurostimulation—stimulation of the nervous system using electrical current—has been used to treat chronic pain, its use treating postsurgical pain has been limited. Here, we report on the clinical application of a novel investigational lead to provide analgesia following total knee arthroplasty. In 5 subjects, leads were inserted percutaneously using ultrasound guidance within 0.5 to 3.0 cm of the femoral and/or sciatic nerve(s). With the delivery of current, pain decreased an average of 63% at rest, with 4 of 5 subjects having relief of > 50%. During passive and active knee flexion, pain decreased an average of 14% and 50%, with 0/3 and 1/2 subjects attaining > 50% relief, respectively. Ultrasound‐guided percutaneous peripheral nerve stimulation may be a practical modality for the treatment of postsurgical pain.

Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Chronic Low Back Pain Provides Sustained Relief: PERCUTANEOUS PNS FOR CHRONIC LBP

The objective of this study was to evaluate the use of percutaneous peripheral nerve stimulation (PNS) for the treatment of chronic low back pain (LBP). Percutaneous PNS offers the potential to provide an effective neuromodulation therapy using a system and fine‐wire leads designed specifically for percutaneous use with history of an excellent safety profile.

The Neuromodulation Appropriateness Consensus Committee on Best Practices for Dorsal Root Ganglion Stimulation: Appropriate Use of DRG Stimulation

The Neuromodulation Appropriateness Consensus Committee (NACC) is dedicated to improving the safety and efficacy of neuromodulation and thus improving the lives of patients undergoing neuromodulation therapies. With continued innovations in neuromodulation comes the need for evolving reviews of best practices. Dorsal root ganglion (DRG) stimulation has significantly improved the treatment of complex regional pain syndrome (CRPS), among other conditions. Through funding and organizational leadership by the International Neuromodulation Society (INS), the NACC reconvened to develop the best practices consensus document for the selection, implantation and use of DRG stimulation for the treatment of chronic pain syndromes.

Peripheral Nerve Stimulation for Treatment of Post-Amputation Pain – A Case Report

Many amputees suffer from postamputation pain, which can be extremely debilitating, decrease quality of life, increase the risk of depression, and negatively affect interpersonal relationships and the ability to work. Present methods of treatment, including medications, are often unsatisfactory in reducing postamputation pain. Electrical stimulation of the nerve innervating the painful area could reduce the pain, but peripheral nerve stimulation is rarely used to treat postamputation pain because present methods require invasive surgical access and precise placement of the leads in close proximity (≤ 2 mm) with the nerve. The present study investigated a novel approach to peripheral nerve stimulation in which a lead was placed percutaneously a remote distance (> 1 cm) away from the femoral nerve in a patient with severe residual limb pain (RLP) 33 years following a below‐knee amputation. Electrical stimulation generated ≥ 75% paresthesia coverage, reduced RLP by > 60%, and improved quality of life outcomes as measured by the pain interference scale of the Brief Pain Inventory‐Short Form (100% reduction in pain interference), Pain Disability Index (74% reduction in disability), and the Patient Global Impression of Change (very much improved) during a 2‐week home trial. There were no adverse events. The ability to generate significant paresthesia coverage and pain relief with a single lead inserted percutaneously and remotely from the target nerve holds promise for providing relief of postamputation pain.

Peripheral Nerve Stimulation for the Treatment of Postamputation Pain-A Case Report: PNS for the Treatment of Postamputation Pain

Many amputees suffer from postamputation pain, which can be extremely debilitating, decrease quality of life, increase the risk of depression, and negatively affect interpersonal relationships and the ability to work. Present methods of treatment, including medications, are often unsatisfactory in reducing postamputation pain. Electrical stimulation of the nerve innervating the painful area could reduce the pain, but peripheral nerve stimulation is rarely used to treat postamputation pain because present methods require invasive surgical access and precise placement of the leads in close proximity (≤ 2 mm) with the nerve. The present study investigated a novel approach to peripheral nerve stimulation in which a lead was placed percutaneously a remote distance (> 1 cm) away from the femoral nerve in a patient with severe residual limb pain (RLP) 33 years following a below‐knee amputation. Electrical stimulation generated ≥ 75% paresthesia coverage, reduced RLP by > 60%, and improved quality of life outcomes as measured by the pain interference scale of the Brief Pain Inventory‐Short Form (100% reduction in pain interference), Pain Disability Index (74% reduction in disability), and the Patient Global Impression of Change (very much improved) during a 2‐week home trial. There were no adverse events. The ability to generate significant paresthesia coverage and pain relief with a single lead inserted percutaneously and remotely from the target nerve holds promise for providing relief of postamputation pain.