scholarly journals Designing a trial of early electrical stimulation to the stroke-affected arm: Qualitative findings on the barriers and facilitators

2021 ◽  
pp. 030802262110087
Author(s):  
Dawn-Marie Walker ◽  
Joanna Fletcher-Smith ◽  
Nikola Sprigg ◽  
Anand Pandyan
Keyword(s):  
Electrical Stimulation ◽  
Focus Groups ◽  
Usual Care ◽  
Occupational Therapists ◽  
Barriers And Facilitators ◽  
Control Group ◽  
Post Intervention ◽  
Staff Support ◽  
Time Restrictions ◽  
Therapist Perspectives

Introduction: This study aimed to explore the barriers and facilitators to implementing early therapeutic electrical stimulation (ES) treatment from both the patient and therapist perspectives as part of a feasibility study. Methods Design: Interviews were conducted with patients and their carers and focus groups with the therapists post-intervention period. Setting: Interviews were in the patient’s homes and for the focus groups in a specialist stroke unit in Nottinghamshire. Subjects: Fifteen patient participants (34% of sample) were interviewed (intervention n = 9; control group n = 3; carers n = 3). Sixteen therapists (9 occupational therapists; 7 physiotherapists) took part in the three focus groups. Intervention: Participants were randomized to receive usual care or usual care and ES to wrist flexors and extensors for 30 min, twice a day, 5 days a week for 3 months. Findings: The barriers to ES treatment cited by the therapists outweighed the barriers mentioned by patients. Therapists’ barriers included lack of confidence and staff knowledge regarding ES and time pressures of delivering the ES. No patients mentioned time as a barrier and considered the treatment regime to be acceptable; however, lack of staff support was mentioned 14 times by them. Conclusion: Although initially the perceived barrier for therapists was time restrictions, after analysing the data, it appears that confidence/knowledge is the real barrier, and time is the manifestation of this underlying self-doubt. Patients were able to confidently self-manage treatment, and although efficacy was not measured, patients volunteered information regarding its perceived benefit, and no adverse effects were reported.

scholarly journals Skeletal Muscle Hypertrophy and Attenuation of Cardio-Metabolic Risk Factors (SHARC) Using Functional Electrical Stimulation-Lower Extremity Cycling in Persons with Spinal Cord Injury. Study Protocol for a randomized clinical trial

2019 ◽  
Author(s):  
Ashraf Gorgey ◽  
Refka E Khalil ◽  
John C Davis ◽  
William Carter ◽  
Ranjodh Gill ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Insulin Sensitivity ◽  
Oxygen Uptake ◽  
Intracellular Signaling ◽  
Muscle Hypertrophy ◽  
Passive Movement ◽  
Control Group ◽  
Post Intervention ◽  
Glucose Effectiveness ◽  
Cord Injury

Abstract Background Persons with spinal cord injury (SCI) are at heightened risks of developing unfavorable cardiometabolic consequences due to physical inactivity. Functional electrical stimulation (FES) and surface neuromuscular electrical stimulation (NMES)-resistance training (RT) have emerged as effective rehabilitation methods that can exercise muscles below the level of injury and attenuate cardio-metabolic risk factors. Our aims are to: determine the impact of 12 weeks of NMES+12 weeks of FES-Lower extremity cycling (LEC) compared to 12 weeks of passive movement + 12 weeks of FES-LEC on 1) oxygen uptake (VO2), insulin sensitivity and glucose disposal in adults with SCI; 2) skeletal muscle size, intramuscular fat (IMF) and visceral adipose tissue (VAT) and; 3) determinants of energy metabolism, protein molecules involved in insulin signaling, muscle hypertrophy and oxygen uptake (IRS-1, AMPK, GLUT-4, IGF-1, mTOR, Akt and PGC-1 α) and electron transport chain (ETC) activities. Methods/Design Forty-eight persons aged 18-65 years with chronic (> 1 year) SCI/D (AIS A-C) at the C5-L2 levels, equally sub-grouped by cervical or sub-cervical injury levels and time since injury, will be randomized into either NMES+FES group or Passive + FES (control group). The NMES+FES group will undergo 12 weeks of evoked RT using twice-weekly NMES and ankle weights followed by twice-weekly progressive FES-LEC for an additional 12 weeks. The control group will undergo 12 weeks of passive movement followed by 12 weeks of progressive FES-LEC. Measurements will be performed at baseline (B; week 0), post-intervention 1 (P1; week 13) and post-intervention 2 (P2; week 25) and will include VO2 measurements, insulin sensitivity and glucose effectiveness using intravenous glucose tolerance; magnetic resonance imaging to measure muscle, IMF and VAT areas; muscle biopsy to measure protein expression and intracellular signaling as well as mitochondrial ETC function. Discussion Training through NMES+RT may evoke muscle hypertrophy and positively impact oxygen uptake, insulin sensitivity and glucose effectiveness. This may result in beneficial outcomes on metabolic activity, body composition profile, mitochondrial ETC and intracellular signaling related to insulin action and muscle hypertrophy. In the future, NMES-RT may be added to FES-LEC to improve the workloads achieved in the rehabilitation of SCI persons and further decrease muscle wasting and cardio-metabolic risks. Clinical trials # NCT02660073

scholarly journals Effect of 8-week treadmill running with peroneal muscle functional electrical stimulation on laterally deviated centre of plantar pressure position and star excursion balance test performance

2021 ◽  
Vol 8 ◽  
pp. 205566832110215
Author(s):  
Zoe A Bamber ◽  
Patrick C Wheeler ◽  
Ian D Swain ◽  
Daniel TP Fong
Keyword(s):  
Electrical Stimulation ◽  
Ankle Sprain ◽  
Functional Electrical Stimulation ◽  
Training Programme ◽  
Treadmill Running ◽  
Control Group ◽  
Post Intervention ◽  
Balance Test ◽  
Significant Difference ◽  
Star Excursion Balance Test

Introduction Ankle sprain is a common injury that can have long-term sequelae resulting in pain, swelling and a reduction of physical activity participation. Previous research has shown a laterally deviated centre of pressure (COP) during running gait increases the risk of lateral ankle sprain. As a method of altering COP, electrical stimulation has been considered. Method A group of 14 healthy males were randomly allocated to case control groups which were single blinded. The intervention involved an 8-week training programme of functional electrical stimulation to the peroneal muscles during treadmill running, with a sham control group. Outcomes were COP position and star excursion balance test. Statistical analysis was through SPSS using a combination of MANOVA, T-tests and Wilcoxon signed rank Results There was a significant difference in the results post intervention at max pressure for intervention M = 0.7(±0.7) and control M = −6.0 (±4.6) conditions; t(6) = −2.9, p < 0.05 Conclusion It has been demonstrated that FES can alter COP during max pressure in running gait after an 8-week training programme, although carry over effect appears limited and further testing is required.

scholarly journals Technology-supported sitting balance therapy versus usual care in the chronic stage after stroke: A pilot randomized controlled trial

2021 ◽  
Author(s):  
Liselot Thijs ◽  
Eline Voets ◽  
Evelien Wiskerke ◽  
Thomas Nauwelaerts ◽  
Yves Arys ◽  
...  
Keyword(s):  
Usual Care ◽  
Balance Training ◽  
Group Versus ◽  
Chronic Stroke ◽  
Control Group ◽  
Post Intervention ◽  
Functional Balance ◽  
Randomized Controlled ◽  
Sitting Balance ◽  
Experimental Group

Abstract Insights in evidence on sitting balance and trunk rehabilitation have not resulted in specific device development. Hence, intensive one-by-one therapist-patient guidance is still required. We developed a novel rehabilitation prototype, specifically aimed at providing sitting balance therapy. In this study, we investigated if technology-supported sitting balance training was feasible and safe in chronic stroke patients and we evaluated whether clinical outcomes improved after a four-week programme when compared with usual care. Methods. In this parallel-group, assessor-blinded, randomized controlled pilot trial, we divided first event chronic stroke participants randomly into two groups. The experimental group received usual care plus additional therapy supported by rehabilitation technology consisting of 12 sessions of 50 minutes of therapy in four weeks. The control group received usual care only. We assessed all participants twice pre-intervention and once post-intervention. Feasibility and safety were descriptively analysed. Between-group analysis evaluated the differences in changes in motor and functional outcomes. Results. In total, 30 participants were recruited and 29 completed the trial (experimental group, n=14; control group, n=15). There were no between-group differences at baseline. Therapy was evaluated feasible by participants and therapist. There were no serious adverse events during sitting balance therapy. Changes in clinical outcomes from pre- to post-intervention demonstrated an increase in the experimental compared to the control group for trunk function; mean (standard deviation [SD]): 7.07 (1.69) versus 0.33 (2.35) points on trunk impairment scale (p<.000), maximum walking speed on 10-meter walk test (0.16 (0.16) m/s in the experimental group versus 0.06 (0.06) m/s in the control group; p=.003), and functional balance measured using Berg balance scale (median [interquartile range] 4.5 (5) points in the experimental group versus 0 (4) points in the control group (p=.014). Conclusions. Technology-supported sitting balance training in persons with chronic stroke is feasible and safe. A four-week, 12-hour programme on top of usual care suggests beneficial effects for trunk function, maximum gait speed and functional balance.Trial Registration: ClinicalTrials.gov identifier: NCT04467554, https://clinicaltrials.gov/ct2/show/NCT04467554, date of Registration: 13 July 2020.

scholarly journals No effect of intradialytic neuromuscular electrical stimulation on inflammation and quality of life: a randomized and parallel design clinical trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ana C. B. Marini ◽  
Reika D. Motobu ◽  
Patrícia C. B. Lobo ◽  
Paula A. Monteiro ◽  
Gustavo D. Pimentel
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Electrical Stimulation ◽  
Neuromuscular Electrical Stimulation ◽  
High Sensitivity ◽  
Interleukin 10 ◽  
Control Group ◽  
Post Intervention ◽  
Parallel Design

AbstractNeuromuscular electrical stimulation (NMES) elicits muscle contraction and has been shown to improvement of quality of life. However, if NMES improvement the quality of life and attenuate the inflammation is not fully understood. Therefore, our aim sought to assess the effects of short-term of intradialytic NMES on inflammation and quality of life in patients with chronic kidney disease patients undergoing hemodialysis. A randomized clinical trial conducted with parallel design enrolled adult hemodialysis patients three times a week during 1 month. Patients were randomly assigned to two groups (control group, n = 11; 4F/7 M) or (NMES group, n = 10; 4F/6 M). Pre-and post-intervention, was measured the high-sensitivity C reactive protein, interleukin-6, interleukin-10, and TNFα by the ELISA, and quality of life was applied using the SF-36. During each hemodialysis session, NMES was applied bilaterally at thigh and calves for 40 min. There was not change in cytokines (hs-CRP, IL-6, IL-10, and TNFα) concentrations time × group interaction. In addition, no difference was found in eight domains of quality of life. In addition, the groups did not differ for muscle strength and muscle mass. In conclusion, we found that intradialytic NMES did not change inflammation neither quality of life.

scholarly journals Technology-supported sitting balance therapy versus usual care in the chronic stage after stroke: a pilot randomized controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Liselot Thijs ◽  
Eline Voets ◽  
Evelien Wiskerke ◽  
Thomas Nauwelaerts ◽  
Yves Arys ◽  
...  
Keyword(s):  
Usual Care ◽  
Gait Speed ◽  
Balance Training ◽  
Chronic Stroke ◽  
Control Group ◽  
Post Intervention ◽  
Functional Balance ◽  
Randomized Controlled ◽  
Sitting Balance ◽  
Experimental Group

Abstract Background Technology development for sitting balance therapy and trunk rehabilitation is scarce. Hence, intensive one-to-one therapist-patient training is still required. We have developed a novel rehabilitation prototype, specifically aimed at providing sitting balance therapy. We investigated whether technology-supported sitting balance training was feasible and safe in chronic stroke patients and we determined whether clinical outcomes improved after a four-week programme, compared with usual care. Methods In this parallel-group, assessor-blinded, randomized controlled pilot trial, we divided first-event chronic stroke participants into two groups. The experimental group received usual care plus additional therapy supported by rehabilitation technology, consisting of 12 sessions of 50 min of therapy over four weeks. The control group received usual care only. We assessed all participants twice pre-intervention and once post-intervention. Feasibility and safety were descriptively analysed. Between-group analysis evaluated the pre-to-post differences in changes in motor and functional outcomes. Results In total, 30 participants were recruited and 29 completed the trial (experimental group: n = 14; control group: n = 15). There were no between-group differences at baseline. Therapy was evaluated as feasible by participants and therapist. There were no serious adverse events during sitting balance therapy. Changes in clinical outcomes from pre- to post-intervention demonstrated increases in the experimental than in the control group for: sitting balance and trunk function, evaluated by the Trunk Impairment Scale (mean points score (SD) 7.07 (1.69) versus 0.33 (2.35); p < 0.000); maximum gait speed, assessed with the 10 Metre Walk Test (mean gait speed 0.16 (0.16) m/s versus 0.06 (0.06) m/s; p = 0.003); and functional balance, measured using the Berg balance scale (median points score (IQR) 4.5 (5) versus 0 (4); p = 0.014). Conclusions Technology-supported sitting balance training in persons with chronic stroke is feasible and safe. A four-week, 12-session programme on top of usual care suggests beneficial effects for trunk function, maximum gait speed and functional balance. Trial Registration:ClinicalTrials.gov identifier: NCT04467554, https://clinicaltrials.gov/ct2/show/NCT04467554, date of Registration: 13 July 2020.

scholarly journals Effects of Combining Diaphragm Training with Electrical Stimulation on Balance, Pain, and Function in Athletes with Chronic Low Back Pain : A Randomized Clinical Trial

2020 ◽  
Author(s):  
Khadijeh Otadi ◽  
Noureddin Nakhostin Ansari ◽  
Shahriar Sharify ◽  
Zahra Fakhari ◽  
Hadi Sarafraz ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Dynamic Balance ◽  
Static Stability ◽  
Core Stability ◽  
Control Group ◽  
Low Back ◽  
Young Athletes ◽  
Post Intervention ◽  
And Function ◽  
Experimental Group

Abstract Background: It is unknown how diaphragm training combined with electrical stimulation affect balance, core stability, pain, and function in athletes with chronic low back pain (CLBP). This study aimed to explore the effects of combining diaphragm training with electrical stimulation on core stability, dynamic balance, pain, and function in young athletes with nonspecific CLBP.Methods: The design was a randomized clinical trial A total of 24 young adult athletes (12 women, 12 men) with non-specific CLBP were randomly allocated into experimental and control group. The experimental group received diaphragm training plus Transcutaneous Electrical Nerve Stimulation (TENS), while the control group received only TENS. Both groups underwent 12 sessions over a 4-week period. Static stability, dynamic balance, pain, and function were measured pre- and post-intervention.Results: Significant improvements in pain and function scores were found in both groups after completing the interventions. However, only the experimental group showed significant improvements in the static stability and dynamic balance post-intervention. The experimental group showed greater improvements in pain and static stability. No significant differences in function or dynamic balance were observed between the groups. Conclusions: The present study indicates that diaphragm training plus TENS can improve static stability, dynamic balance, function, and pain in young athletes with non-specific CLBP. It seems beneficial to add diaphragm training to rehabilitation programs for athletes with CLBP.Trial registration: The trial was retrospectively registered at the Iranian Registry of Clinical Trials on www.irct.ir (Identification number: IRCT20090228001719N8).

scholarly journals Skeletal Muscle Hypertrophy and Attenuation of Cardio-Metabolic Risk Factors (SHARC) Using Functional Electrical Stimulation-Lower Extremity Cycling in Persons with Spinal Cord Injury. Study Protocol for a randomized clinical trial

2019 ◽  
Author(s):  
Ashraf Gorgey ◽  
Refka E Khalil ◽  
John C Davis ◽  
William Carter ◽  
Ranjodh Gill ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Insulin Sensitivity ◽  
Oxygen Uptake ◽  
Intracellular Signaling ◽  
Muscle Hypertrophy ◽  
Passive Movement ◽  
Control Group ◽  
Post Intervention ◽  
Glucose Effectiveness ◽  
Cord Injury

Abstract Background Persons with spinal cord injury (SCI) are at heightened risks of developing unfavorable cardiometabolic consequences due to physical inactivity. Functional electrical stimulation (FES) and surface neuromuscular electrical stimulation (NMES)-resistance training (RT) have emerged as effective rehabilitation methods that can exercise muscles below the level of injury and attenuate cardio-metabolic risk factors. Our aims are to determine the impact of 12 weeks of NMES+12 weeks of FES-Lower extremity cycling (LEC) compared to 12 weeks of passive movement+12 weeks of FES-LEC on 1) oxygen uptake (VO2), insulin sensitivity and glucose disposal in adults with SCI; 2) skeletal muscle size, intramuscular fat (IMF) and visceral adipose tissue (VAT) and; 3) protein expression of energy metabolism, protein molecules involved in insulin signaling, muscle hypertrophy and oxygen uptake and electron transport chain (ETC) activities. Methods/Design Forty-eight persons aged 18-65 years with chronic (> 1 year) SCI/D (AIS A-C) at the C5-L2 levels, equally sub-grouped by cervical or sub-cervical injury levels and time since injury, will be randomized into either NMES+FES group or Passive+FES (control group). The NMES+FES group will undergo 12 weeks of evoked RT using twice-weekly NMES and ankle weights followed by twice-weekly of progressive FES-LEC for an additional 12 weeks. The control group will undergo 12 weeks of passive movement followed by 12 weeks of progressive FES-LEC. Measurements will be performed at baseline (B; week 0), post-intervention 1 (P1; week 13) and post-intervention 2 (P2; week 25) and will include VO2 measurements, insulin sensitivity and glucose effectiveness using intravenous glucose tolerance test; magnetic resonance imaging to measure muscle, IMF and VAT areas; muscle biopsy to measure protein expression and intracellular signaling as well as mitochondrial ETC function. Discussion Training through NMES+RT may evoke muscle hypertrophy and positively impact oxygen uptake, insulin sensitivity and glucose effectiveness. This may result in beneficial outcomes on metabolic activity, body composition profile, mitochondrial ETC and intracellular signaling related to insulin action and muscle hypertrophy. In the future, NMES-RT may be added to FES-LEC to improve the workloads achieved in the rehabilitation of persons with SCI and further decrease muscle wasting and cardio-metabolic risks.

scholarly journals Does cycling induced by functional electrical stimulation enhance motor recovery in the subacute phase after stroke? A systematic review and meta-analysis

2020 ◽  
Vol 34 (11) ◽  
pp. 1341-1354
Author(s):  
Emilia Ambrosini ◽  
Monica Parati ◽  
Giorgio Ferriero ◽  
Alessandra Pedrocchi ◽  
Simona Ferrante
Keyword(s):  
Electrical Stimulation ◽  
Activities Of Daily Living ◽  
Usual Care ◽  
Functional Electrical Stimulation ◽  
Daily Living ◽  
Mean Difference ◽  
Control Group ◽  
Stroke Survivors ◽  
Subacute Stroke ◽  
Cycling Training

Objective: To investigate the effects of cycling with functional electrical stimulation on walking, muscle power and tone, balance and activities of daily living in subacute stroke survivors. Data Sources: Ten electronic databases were searched from inception to February 2020. Review methods: Inclusion criteria were: subacute stroke survivors (<6 months since stroke), an experimental group performing any type of cycling training with electrical stimulation, alone or in addition to usual care, and a control group performing usual care alone. Two reviewers assessed eligibility, extracted data and analyzed the risks of bias. Standardized Mean Difference (SMD) or Mean Difference (MD) with 95% Confidence Intervals (CI) were estimated using fixed- or random-effects models to evaluate the training effect. Results: Seven randomized controlled trials recruiting a total of 273 stroke survivors were included in the meta-analyses. There was a statistically significant, but not clinically relevant, effect of cycling with electrical stimulation compared to usual care on walking (six studies, SMD [95% CI] = 0.40 [0.13, 0.67]; P = 0.004), capability to maintain a sitting position (three studies, MD [95% CI] = 7.92 [1.01, 14.82]; P = 0.02) and work produced by the paretic leg during pedaling (2 studies, MD [95% CI] = 8.13 [1.03, 15.25]; P = 0.02). No significant between-group differences were found for muscular power, tone, standing balance, and activities of daily living. Conclusions: Cycling training with functional electrical stimulation cannot be recommended in terms of being better than usual care in subacute stroke survivors. Further investigations are required to confirm these results, to determine the optimal training parameters and to evaluate long-term effects.

Promoting Key Family Practices of Common Childhood Illnesses among Mothers with Under-Five Children in Selected Military Communities

2019 ◽  
Vol 31 (2) ◽  
pp. 153-158
Keyword(s):  
Health Promotion ◽  
Health Promotion Program ◽  
Control Group ◽  
Study Group ◽  
Post Intervention ◽  
Under Five ◽  
Under Five Children ◽  
Eta Squared ◽  
Family Practices ◽  
Knowledge And Practice

Mothers are fundamental caregivers for under-five children and thus, family participation in child health services is very important. Therefore, a quasi-experimental study for promoting key family practices of mothers with under-five children was conducted among 278 respondents from Oaktwin Cantonment and Inndaing Cantonment in 2014. Data were collected by face-to-face interview with pretested structured questionnaire. Health promotion program including health education and advocacy for unit supports was implemented in study group. Before intervention, baseline data of respondents and pre-intervention knowledge and practices levels were identified. In the three-month and six-month after interventions, post-intervention data collection was done in both groups and data were analyzed. Findings show that there was a statistically significant difference of knowledge and practice scores between study group and control group after three-month interventions (t=10.827, p<0.0001, eta squared=0.297 and t=8.2, p<0.0001, eta squared=0.195, respectively), and six-month post-intervention (t=10.035, p<0.0001, eta squared=0.267 and t=8.773, p<0.0001, eta squared=0.304, respectively). Moreover, knowledge and practice level within study groups have a significant effect for time (F=160.45, p<0.0001 and F=113.06, p<0.0001, respectively) and the magnitude of this effect was also large (eta squared=0.699 for knowledge and 0.621 for practice). At the same time, knowledge and practice of control group have a significant effect for time (F=3.648, p=0.029 and F=19.564, p<0.0001, respectively) but this effect was very small. It can be asserted that health promotion program can improve the knowledge and practice of mothers regarding key family practices. The findings of current study might be a cornerstone for improvement of maternal knowledge and practice on caring for children in the military community.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

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