Meta-epidemiologic review: blinding and sham treatment in clinical trial design for osteopathic manipulative treatment research.

Objective: To analyze the consistency of study designs in osteopathic manipulative treatment (OMT) research, focusing on blinding protocols and the use of sham treatments. Data Source and Study Selection: PubMed and CINAHL were searched in January 2022. A total of 83 research studies between 2009 and 2021 were selected based on the presence of a double- or single-blind study design and/or sham treatment. Data Extraction and Analysis: Data regarding the primary outcome measures, blinding design, measures used to determine success of blinding, osteopathic technique used, and sham technique used for each eligible study were extracted and compared among different study designs. Results: A total of 5968 subjects participated in the 83 trials. The study population mainly consisted of asymptomatic individuals (25%) and chronic back pain patients (19%). Light touch was employed most commonly (49%) as the sham treatment, followed by unrelated sham (20%) and incomplete maneuvers (20%). Most studies blinded the subjects (80%) or the outcome evaluator/data analyzer (71%), while only 20% studies blinded the osteopathic physicians. Conclusions: Strict double-blinding is achievable for OMT clinical research by blinding the subjects and data collectors/analyzers rather than the osteopaths providing the actual treatment. The use of questionnaires to determine the success of blinding should be considered. Additionally, including OMT-naïve subjects is preferred to enhance blinding success. When designing a sham treatment, careful consideration should be given to blinding the data collector, accounting for the placebo effect, and incorporating an additional no-treatment control group to improve the rigor of the study design.

The effect of photobiomodulation on hearing loss: A systematic review.

OBJECTIVES: To assess outcomes associated with photobiomodulation therapy (PBMT) for hearing loss in human and animal studies. DESIGN: Systematic review and narrative synthesis in accordance with PRISMA guidelines. SETTING: Data bases searched: MEDLINE, EMBASE, CENTRAL, ClinicalTrials.gov and Web of Science. No limits were placed on language or year of publication. Review conducted in accordance with the PRISMA 2020 statement. PARTICIPANTS: All human and animal subjects treated with PBMT for hearing loss. MAIN OUTCOME MEASURES: Pre- and post-PBMT audio metric outcomes. RESULTS: Searches identified 122 abstracts and 49 full text articles. Of these, 17 studies met the inclusion criteria, reporting outcomes in 327 animals (11 studies), 30 humans (1 study), and 40 animal specimens (5 studies). PBMT parameters included 6 different wavelengths: 908 nm (1 study), 810 nm (1 study), 532 & 635 nm (1 study), 830 nm (3 studies), 808 nm (11 studies). The duration ranged from 4 to 60 minutes in a session, and the follow-up ranged from 5-28 days. Outcomes improved significantly when wavelengths within the range of 800-830 nm were used, and with greater duration of PBMT exposure. Included studies predominantly consisted of non-randomized controlled trials (10 studies). CONCLUSIONS: Hearing outcomes following PBMT appear to be superior to no PBMT for subjects with hearing loss, although higher level evidence is required to verify this. PBMT enables concentrated, focused delivery of light therapy to the inner ear through a non-invasive manner with minimal side effects. As a result of heterogeneity in reporting PBMT parameters and outcomes across the included studies, direct comparison is challenging.

The effect of photobiomodulation on tinnitus: a systematic review.

OBJECTIVE: To establish outcomes following photobiomodulation therapy for tinnitus in humans and animal studies. METHODS: A systematic review and narrative synthesis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The databases searched were: Medline, Embase, Cochrane Central Register of Controlled Trials ('Central'), ClinicalTrials.gov and Web of Science including the Web of Science Core collection. There were no limits on language or year of publication. RESULTS: The searches identified 194 abstracts and 61 full texts. Twenty-eight studies met the inclusion criteria, reporting outcomes in 1483 humans (26 studies) and 34 animals (2 studies). Photobiomodulation therapy parameters included 10 different wavelengths, and duration ranged from 9 seconds to 30 minutes per session. Follow up ranged from 7 days to 6 months. CONCLUSION: Tinnitus outcomes following photobiomodulation therapy are generally positive and superior to no photobiomodulation therapy; however, evidence of long-term therapeutic benefit is deficient. Photobiomodulation therapy enables concentrated, focused delivery of light therapy to the inner ear through a non-invasive manner, with minimal side effects.

Triple Canal Occlusion for the Treatment of Intractable Menière's Disease.

OBJECTIVE: Menière's disease can be a debilitating condition but in most cases the symptoms are controlled by lifestyle changes and medical management. However, some patients remain symptomatic despite medical treatment and have the option of more invasive surgical treatments. Surgical intervention for Menière's includes a range of interventions from grommet insertion, intratympanic steroids/Gentamicin, endolymphatic sac decompression, labyrinthectomy, and vestibular neurectomy. A recently described technique involves the occlusion of all three semi-circular canals as an alternative in intractable Menière's disease. STUDY DESIGN: This is a case series of three patients who underwent triple canal occlusion for the treatment of intractable Menière's disease. SETTING: Patients were selected from those who were referred to Queen Elizabeth Hospital in Birmingham, a tertiary referral center. PATIENTS: Patients who were severely symptomatic despite medical treatment who were considering ablative therapy were offered the option of triple canal occlusion as an alternative. INTERVENTION: We report a series of Menière's patients treated by triple canal occlusion, describe the rationale behind this intervention, the surgical technique, and preliminary results. MAIN OUTCOME MEASURE: Each patient was followed up for a minimum of 2 years following the procedure. The main outcomes measures were the class of vertigo control and hearing threshold levels according to the American Academy of Otolaryngology-Head and Neck Surgery guidelines. RESULTS: Of the three patients, two were men and one was woman, the age range was 45 years to 61 years old. Two patients with unilateral disease achieved class A control whereas one patient with bilateral disease achieved class B control. Two patients who underwent the procedure had little or no effect to their hearing on the treated side however one patient suffered a 30 dB hearing loss on the operative side. CONCLUSIONS: Based on our limited experience and the early reports in the literature we consider that there are potential patient benefits for triple canal occlusion for intractable Menière's disease as an alternative to vestibular neurectomy due to the reduced morbidity and long-term efficacy.

Implantable microphones as an alternative to external microphones for cochlear implants.

Totally implantable cochlear implants may be able to address many of the problems cochlear implant users have around cosmetic appearances, discomfort, and restriction of activities. The major technological challenges that need to be solved to develop a totally implantable device relate to implanted microphone performance. Previous attempts at implanting microphones for cochlear implants have not performed as well as conventional cochlear implant microphones, and in addition have struggled with extraneous body or surface contact noise. Microphones can be implanted under the skin or act as sensors in the middle ear; however, evidence from middle ear implants suggest body and contact noise can be overcome by converting ossicular chain movements into digital signals. This article reviews implantable microphone systems and discusses the technology behind them.