A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

<p>Abstract</p> <p>Background</p> <p>Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness.</p> <p>Methods/Design</p> <p>This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic). Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT); referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide), will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention.</p> <p>Discussion</p> <p>This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support.</p> <p>Trial Registration</p> <p>Australian and New Zealand Clinical Trials Registry ANZTCN: <a href="http://www.anzctr.org.au/ACTRN12609000465257.aspx">ACTRN12609000465257</a></p

Intense Therapeutic Ultrasound for Pain Relief in the Treatment for Chronic Plantar Fasciopathy

Background: Intense therapeutic ultrasound (ITU) is an innovative ultrasound-based therapy where sound waves are concentrated into select musculoskeletal tissue. These focused waves generate thermal coagula at a controlled depth and space while preserving surrounding tissues. A multicenter study was conducted evaluating the efficiency, safety, and patient tolerance of ITU for the treatment of chronic plantar fasciitis (CPF) pain. Methods: Seventy-four CPF patients, having failed conservative and/or minimally invasive treatment, participated in the study. Randomized participants either received 2 ITU treatments or 2 sham ITU treatments in addition to standard-of-care therapy. Plantar fascia pain was assessed pretreatment and at 4, 8, 12, and 26 weeks after treatment. Diagnostic ultrasonographic images were analyzed to examine hypoechoic, perifascial lesions whose volumes were calculated until week 12. Function and patient satisfaction were measured using self-reported outcome measures. Results: The treated group reported significant average pain reduction (–26%, –33%, –43%) and hypoechoic lesion volume (–33%, –53%, –68%) at weeks 4, 8, and 12 compared to baseline. Although the control/sham group reported insignificant pain changes at the same time points (–5%, +8%, and +2%) and increased hypoechoic lesion volume (+15%, +28%, +58%). Treated patients reported a significant increase in daily living activities (+28%, +42%, +47%, +40%) compared to the sham/control group (+0.12%, +12%, +3%, +21%). Patient satisfaction remained more than 80% at weeks 8, 12, and 26 for all treatment groups. Conclusion: ITU is an effective pain relief treatment for CPF, which is refractory to either conservative measures or minimally invasive treatments. Level of Evidence: Level II. </jats:sec

Randomized Controlled Trial of Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis

Category: Sports Introduction/Purpose: Initial treatment of plantar fasciitis (PF), consisting of anti-inflammatories, stretching and in-shoe orthosis (heel pad, heel wedge, or arch support), leads to symptomatic resolution in over 90% of patients but takes 3-6 months. This study was conducted to test the effectiveness of a minimally invasive modality, intense therapeutic ultrasound (ITU), in accelerating the healing of chronic plantar fasciitis (PF). ITU uses high-frequency high-intensity focused ultrasound to create small thermal injury zones inside soft tissue without damage to surrounding structures. ITU has been shown to initiate a tissue repair cascade and promote collagen generation in dermal and musculoskeletal tissue and is FDA approved for use in non-surgical brow lifts [1,2]. The goal of this study was to determine if ITU when combined with standard therapy could speed the healing of chronic PF. Methods: 47 patients with chronic (greater than 3 months) heel pain due to PF were randomized to standard therapy (anti- inflammatory pills, stretching, and gel heel cups) plus ITU (“ITU”, n=33) or standard therapy plus sham ITU (“control”, n=14) groups. ITU treatments were administered at enrollment and two-weeks later using a custom 3.3 MHz therapeutic ultrasound system (Guided Therapy Systems, Mesa, AZ). Sham treatment utilized the same protocol but with the energy set to 0 Joules. Treatment effect was assessed at 2, 4, 6, and 12 weeks after the initiation of treatment using diagnostic ultrasound and patient reported outcomes (PROMIS physical function computer adaptive test, PROMIS global health, Foot Function Index pain subscale, and a non-validated heel pain specific questionnaire). Ultrasound images were analyzed to determine the size of lesions within the PF. Both the sonographer and the study coordinator administering the patient reported outcome instruments were blinded to group assignment. Results: 38 patients completed the 12 week study (ITU: n=37, Control: n=11.). The ITU group reported a significantly greater reduction in heel pain scores [Mean 8.27, SD 4.69, P=0.027] compared to the control group [Mean 2.25, SD 5.92] (Figure 1). Ultrasound imaging showed an 81% decrease in perifascial lesion size in the treatment group, compared to a 26% increase in lesion size in the control group (Figure 2). Conclusion: Preliminary results of this clinical study of noninvasive ITU for the treatment of chronic PF showed that ITU treatment as compared to sham control lead to a larger and more rapid reduction of heel pain and perifascial lesion size. ITU holds promise as a potential therapy to accelerate the healing of chronic plantar fasciiti