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Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study.

ABSTRACT: BACKGROUND:Osteopathic manipulative treatment (OMT) of the sphenopalatine ganglion (SPG) is used empirically for the treatment of rhinitis and snoring and is thought to increase pharyngeal stability. This trial was designed to study the effects of this treatment on pharyngeal stability evaluated by critical closing pressure in obstructive sleep apnoea syndrome. METHODS:This single-centre, randomized, crossover, double-blind study compared active manipulation and sham manipulation of the SPG. Randomization was computer-generated. Patients each received one active manipulation and one sham manipulation at an interval of 21 days and were evaluated 30 min and 48 h after each session administered by a qualified osteopath. Neither the patients, nor the investigator performing the evaluations were informed about the order of the two techniques (double-blind). The primary endpoint was the percentage of responding patients presenting increased pharyngeal stability defined by a variation of critical closing pressure (Pcrit) of at least -4 cmH2O at 30 min. Secondary endpoints were the variation of Pcrit in absolute values, sleepiness and snoring. Others endpoints were lacrimation (Schirmer's test), induced pain, sensations experienced during OMT. RESULTS:Ten patients were included and nine (57 [50; 58] years, comprising 7 men, with an apnoea-hypopnoea index of 31.0 [25.5; 33.2]/h; (values are median [quartiles])) were analysed. Seven patients were analysed for the primary endpoint and nine patients were analysed for secondary endpoints. Five patients responded after active manipulation versus no patients after sham manipulation (p?=?0.0209). Active manipulation induced more intense pain (p?=?0.0089), increased lacrimation (ns) and more tactile, nociceptive and gustatory sensations (13 versus 1) compared to sham manipulation. No significant difference was observed for the other endpoints. CONCLUSIONS:Osteopathic manipulative treatment of the SPG may improve pharyngeal stability in obstructive sleep apnoea syndrome. This trial validates the feasibility of the randomized, controlled, double-blind methodology for evaluation of this osteopathic treatment. Studies on a larger sample size must specify the efficacy on the apnoea-hypopnoea index. TRIAL REGISTRATION:The study was retrospectively registered in the clinicaltrial.gov registry under reference NCT01193738 on 1st September 2010 (first inclusion May 19, 2010).

SUBMITTER: Jacq O

PROVIDER: S-EPMC5738827 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study.

Jacq Olivier O Arnulf Isabelle I Similowski Thomas T Attali Valérie V

BMC complementary and alternative medicine 20171220 1

<h4>Background</h4>Osteopathic manipulative treatment (OMT) of the sphenopalatine ganglion (SPG) is used empirically for the treatment of rhinitis and snoring and is thought to increase pharyngeal stability. This trial was designed to study the effects of this treatment on pharyngeal stability evaluated by critical closing pressure in obstructive sleep apnoea syndrome.<h4>Methods</h4>This single-centre, randomized, crossover, double-blind study compared active manipulation and sham manipulation ...[more]

PMID: 29262824

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Project description:Chronic pain is a common condition that often interferes with work or other activities. Guidelines support the use of non-pharmacological treatments, such as spinal manipulation, in patients with chronic pain. Osteopathic physicians in the United States are uniquely positioned to manage chronic pain because their professional philosophy embraces the biopsychosocial model and they are trained in the use of osteopathic manipulative treatment (OMT) to complement conventional medical care. This narrative review provides current perspectives on the osteopathic approach to chronic pain management, including evidence for the efficacy of OMT based on systematic searches of the biomedical literature and the ClinicalTrials.gov database. Men, persons with low levels of education, and non-White and Hispanic patients are significantly less likely to have received OMT during their lifetime. Patients with low back and neck pain are most likely to be treated with OMT, and osteopathic manipulative medicine specialty physicians and family medicine physicians most often use OMT. However, many osteopathic physicians report using OMT infrequently. Although OMT is considered safe, based on millions of patient encounters over more than a century, there is limited evidence on its efficacy in treating chronic pain. The lone exception involves chronic low back pain, wherein there is evidence from systematic reviews, a large clinical trial, and observational studies. There is lesser evidence to support cost effectiveness and patient satisfaction associated with OMT for chronic pain. The only clinical practice guideline established by the American Osteopathic Association recommends that OMT should be used to treat chronic low back pain in patients with somatic dysfunction. Given the philosophy of osteopathic medicine, universal training of osteopathic physicians to use OMT, and national guidelines supporting non-pharmacological treatments for chronic pain, it is unclear why OMT use is reported to be remarkably low in physician surveys.

Project description:BackgroundMechanical ventilation is a common therapy in operating rooms and intensive care units. When ill-adapted, it can lead to ventilator-induced lung injury (VILI), which is associated with poor outcomes. Excessive regional pulmonary strain is thought to be a major mechanism responsible for VILI. Scarce bedside methods exist to measure regional pulmonary strain. We propose a novel way to measure regional pleural strain using ultrasound elastography. The objective of this study was to assess the feasibility and reliability of pleural strain measurement by ultrasound elastography and to determine if elastography parameters would correlate with varying tidal volumes.MethodsA single-blind randomized crossover proof of concept study was conducted July to October 2017 at a tertiary care referral center. Ten patients requiring general anesthesia for elective surgery were recruited. After induction, patients received tidal volumes of 6, 8, 10, and 12 mL.kg-1 in random order, while pleural ultrasound cineloops were acquired at 4 standardized locations. Ultrasound radiofrequency speckle tracking allowed computing various pleural translation, strain and shear components. We screened 6 elastography parameters (lateral translation, lateral absolute translation, lateral strain, lateral absolute strain, lateral absolute shear and Von Mises Strain) to identify those with the best dose-response with tidal volumes using linear mixed effect models. Goodness-of-fit was assessed by the coefficient of determination. Intraobserver, interobserver and test-retest reliability were calculated using intraclass correlation coefficients.ResultsAnalysis was possible in 90.7% of ultrasound cineloops. Lateral absolute shear, lateral absolute strain and Von Mises strain varied significantly with tidal volume and offered the best dose-responses and data modeling fits. Point estimates for intraobserver reliability measures were excellent for all 3 parameters (0.94, 0.94, and 0.93, respectively). Point estimates for interobserver (0.84, 0.83, and 0.77, respectively) and test-retest (0.85, 0.82, and 0.76, respectively) reliability measures were good.ConclusionStrain imaging is feasible and reproducible. Future studies will have to investigate the clinical relevance of this novel imaging modality.Clinical trial registrationwww.Clinicaltrials.gov, identifier NCT03092557.

Dataset Information

Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study.

Publications

Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study.

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