Evaluation of the Baha SoundArc in children.

OBJECTIVE: The Baha SoundArc coupling system has been developed as a non-surgical coupling of a Baha sound processor to the skull allowing the transfer of vibrational energy to the cochlear partition via bone conduction pathways. Today, there are several alternatives to this non-surgical approach as the Baha headband/test band, or the Baha Softband, or adhesive patches. Each of these current options have benefits and liabilities. The aim of the study was to evaluate pediatric experience and performance when using two non-surgical options, the Baha SoundArc compared to the Baha Softband. METHODS: Twenty-five children with unilateral mixed or conductive hearing loss aged 5-12 years of age evaluated the use of the Baha SoundArc compared to their existing Baha Softband in a one month take home trial. Participants had a minimum of 3 months experience using the control, Baha Softband. Participants were assessed at baseline and one month following fit of the Baha SoundArc. Measures included an experience and use patient reported outcome, speech perception testing in quiet using Phonetically Balanced Kindergarten (PBK) words, and sound field audiometry. RESULTS: Mean aided soundfield thresholds across the frequency range were 27.6 dB HL for Softband and 26.0 dB HL for SoundArc, which were not significantly different (P = >.05). Mean word recognition score was 80.8% when aided with the Softband device and 85.1% with the SoundArc, which was also not significantly different (P = >.05). Most children favored the aesthetics and usability of the SoundArc over Softband, but comfort ratings were largely similar for both devices. CONCLUSIONS: Bone conduction sound processors mounted on a SoundArc or a Softband resulted in comparable improvements in aided thresholds and speech understanding in children suffering from conductive or mixed hearing loss. Both wearing modalities can be considered equivalent in terms of audiological outcomes, although both patients and clinicians preferred the usability and aesthetics of the SoundArc. The SoundArc provides an alternative wearing option for patients that may otherwise be discouraged by the aesthetics and usability of the Softband device. GOV IDENTIFIER: NCT03333577.

A Systematic Review and Best Evidence Synthesis of the Effectiveness of Therapeutic Facet Joint Interventions in Managing Chronic Spinal Pain.

BACKGROUND: The therapeutic spinal facet joint interventions generally used for the treatment of axial spinal pain of facet joint origin are intraarticular facet joint injections, facet joint nerve blocks, and radiofrequency neurotomy. Despite interventional procedures being common as treatment strategies for facet joint pathology, there is a paucity of literature investigating these therapeutic approaches. Systematic reviews assessing the effectiveness of various therapeutic facet joint interventions have shown there to be variable evidence based on the region and the modality of treatment utilized. Overall, the evidence ranges from limited to moderate. OBJECTIVE: To evaluate and update the clinical utility of therapeutic lumbar, cervical, and thoracic facet joint interventions in managing chronic spinal pain. STUDY DESIGN: A systematic review of therapeutic lumbar, cervical, and thoracic facet joint interventions for the treatment of chronic spinal pain. METHODS: The available literature on lumbar, cervical, and thoracic facet joint interventions in managing chronic spinal pain was reviewed. The quality assessment criteria utilized were the Cochrane Musculoskeletal Review Group criteria and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) for randomized trials and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) for observational studies. The level of evidence was classified at 5 levels from Level I to Level V. Data sources included relevant literature identified through searches on PubMed and EMBASE from 1966 through March 2015, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake consumption. RESULTS: A total of 21 randomized controlled trials meeting appropriate inclusion criteria were assessed in this evaluation. A total of 5 observational studies were assessed. In the lumbar spine, for long-term effectiveness, there is Level II evidence for radiofrequency neurotomy and lumbar facet joint nerve blocks, whereas the evidence is Level III for lumbosacral intraarticular injections. In the cervical spine, for long-term improvement, there is Level II evidence for cervical radiofrequency neurotomy and cervical facet joint nerve blocks, and Level IV evidence for cervical intraarticular injections. In the thoracic spine there is Level II evidence for thoracic facet joint nerve blocks and Level IV evidence for radiofrequency neurotomy for long-term improvement. LIMITATIONS: The limitations of this systematic review include an overall paucity of high quality studies and more specifically the lack of investigations related to thoracic facet joint injections. CONCLUSION: Based on the present assessment for the management of spinal facet joint pain, the evidence for long-term improvement is Level II for lumbar and cervical radiofrequency neurotomy, and therapeutic facet joint nerve blocks in the cervical, thoracic, and lumbar spine; Level III for lumbar intraarticular injections; and Level IV for cervical intraarticular injections and thoracic radiofrequency neurotomy.