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result(s) for
"Webley, Frances"
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Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)
by
Morgan, Alannah
,
Turner, David
,
Durcan, Lorraine
in
Automation
,
Back pain
,
Cellular telephones
2020
IntroductionSelf-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the ‘SupportBack’ internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients.Methods and analysisA three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted.Ethics and disseminationThis trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy.Trial registration numberISRCTN14736486.
Journal Article
Uva-ursi extract and ibuprofen as alternative treatments of adult female urinary tract infection (ATAFUTI): study protocol for a randomised controlled trial
2017
Background
Women with acute uncomplicated urine infection are usually treated with antibiotics. One trial has demonstrated that delayed antibiotic treatment offered without symptom relief results in a modest reduction in antibiotic use. There is some evidence that ibuprofen provides symptom relief and reduces antibiotic use. Uva-ursi, a herbal product, has a traditional use for urinary infection symptom relief. We set out to test: in adult women with suspected UTI who accept the delayed prescription strategy: Do NSAIDs or uva-ursi (a herbal product) provide relief from urinary symptoms and reduce antibiotic use.
Methods/design
Adult women with suspected urinary tract infection presenting to primary care will be randomised using a factorial trial design in which patients will be randomised to one of two interventions as below:
Group 1 – Uva-ursi + advice to take ibuprofen
Group 2 – Placebo + advice to take ibuprofen
Group 3 – Uva-ursi + no advice to take ibuprofen
Group 4 – Placebo + no advice to take ibuprofen
Patients and physicians will be blinded to the randomised group for the herb.
The main outcome is symptom severity at days 2–4 recorded in a validated, self-report diary used in previous studies.
Secondary outcomes include antibiotic use and symptom duration.
In total the trial will require 328 patients in order to achieve at least 90% power for the primary endpoint and 80% for the secondary endpoint.
In accordance with CONSORT guidelines all comparative analyses will be conducted on an intention-to-treat basis using SPSS or similar package.
Discussion
The outcomes from this trial have the potential to modify the current approach to the management of acute urinary symptoms with less dependence on the use of antibiotics.
Trial registration
ISRCTN registry, ID:
ISRCTN43397016
. Registered on 11 February 2015.
Journal Article
HATRIC: a study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for the treatment of acute cough due to lower respiratory tract infection in adults—study protocol for a double blind, placebo-controlled randomised feasibility trial
2019
Background
Acute lower respiratory tract infection is a common acute infection managed in primary care. The current dominant management strategy in the UK is antibiotics, despite widespread publicity regarding antimicrobial resistance and evidence that the small benefits of antibiotics do not outweigh the harms. There is a need to address the rising problem of antibiotic resistance by providing credible alternative strategies, which reduce symptom burden. There is sufficient evidence to recommend the use of
Pelargonium sidoides
root extract in order to warrant undertaking an independent clinical trial.
We propose a feasibility study to demonstrate our ability to recruit and retain patients and conduct a placebo-controlled trial of
Pelargonium sidoides
extract EPs®7630 in lower respiratory tract infection where pneumonia is not suspected. Both the tablet and liquid formulations will be included.
Methods
The HATRIC trial is a double-blind randomised placebo-controlled feasibility study aiming to determine the potential to conduct a fully powered trial of
Pelargonium sidoides
root extract as an alternative to the inappropriate use of antibiotics for acute bronchitis in UK primary care.
Primary care sites will be equally randomised to one of two formulation groups (tablet or liquid preparation). Additionally, within each site, patients will be evenly randomised to active or placebo treatment. Antibiotic consumption will be monitored during the trial, but the use of a delayed prescription strategy is encouraged. The target sample size for this study is 160 patients overall or 40 per arm, recruited from approximately 20 primary care sites. The analysis will be descriptive focusing on estimation with no formal comparison of groups taking place.
Discussion
If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding for a fully powered placebo-controlled trial of
Pelargonium sidoides
root extract for the treatment of lower respiratory tract infections in primary care.
Trial registration
HATRIC was registered on the ISRCTN registry (
ISRCTN17672884
) on 16 August 2018.
Journal Article
Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain
by
Webley, Fran
,
Smith, Peter
,
Hollinghurst, Sandra
in
Acupressure
,
Alexander technique
,
Back pain
2008
Objective To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain.Design Factorial randomised trial.Setting 64 general practices in England.Participants 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription.Interventions Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling.Main outcome measures Roland Morris disability score (number of activities impaired by pain) and number of days in pain.Results Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage −0.58, 95% confidence interval −1.94 to 0.77, six lessons −1.40, −2.77 to −0.03, 24 lessons −3.4, −4.76 to −2.03, and exercise −1.29, −2.25 to −0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score −2.98 and −4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons −18, six lessons −10, massage −7) and quality of life improved significantly. No significant harms were reported.Conclusions One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons.Trial registration National Research Register N0028108728. How does the Alexander Technique work? What are the authors findings about the clinical and cost effectiveness of the treatment? Watch this video to find out (12 mins). media-1 10.1136/bmj.a884V1
Journal Article
The Bronchial Lavage of Pediatric Patients with Asthma Contains Infectious Chlamydia
by
Cirino, Frances
,
Salva, Paul S
,
West, Corrie A
in
Adolescent
,
Adult
,
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
2005
There has been a worldwide increase in the incidence of asthma, and the disease has greatly impacted the public health care system. Chlamydia pneumoniae has been reported as a possible contributing factor in asthma. The organism has been detected by polymerase chain reaction (PCR) in bronchial tissue, but there has been no direct evidence of viability. To determine the frequency of viable Chlamydia in children, blood and bronchoalveolar lavage were collected from 70 pediatric patients undergoing flexible fiberoptic bronchoscopy. Forty-two of these patients had asthma, whereas the remaining patients had various respiratory disorders. Fifty-four percent (38) of the bronchoalveolar lavage samples were PCR-positive for Chlamydia, and 31% (22) of the PCR-positive samples were positive when cultured on macrophages. Twenty-eight samples (40%) and 14 samples (20%) of the PCR- and culture-positive samples, respectively, were from patients with asthma. Culture of the blood samples revealed that 24 (34.3%) of 70 were positive for Chlamydia compared with 8 (11%) of 70 matched nonrespiratory control subjects (p < 0.01); 17 (24%) of the positive blood cultures from the respiratory group were from patients with asthma. Elevation of total IgE was strongly associated with lavage culture positivity for Chlamydia. We therefore conclude that viable Chlamydia pneumoniae organisms are frequently present in the lung lavage fluid from this cohort of predominantly asthmatic pediatric patients.
Journal Article
Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain
2008
To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain.
Factorial randomised trial. Setting 64 general practices in England.
579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription.
Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling.
Roland Morris disability score (number of activities impaired by pain) and number of days in pain.
Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks were lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported.
One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons.
Journal Article
Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain: economic evaluation
by
Webley, Fran
,
Little, Paul
,
Beattie, Angela
in
Alexander technique
,
Ambulatory Care - economics
,
Back pain
2008
Objective An economic evaluation of therapeutic massage, exercise, and lessons in the Alexander technique for treating persistent back pain.Design Cost consequences study and cost effectiveness analysis at 12 month follow-up of a factorial randomised controlled trial.Participants 579 patients with chronic or recurrent low back pain recruited from primary care.Interventions Normal care (control), massage, and six or 24 lessons in the Alexander technique. Half of each group were randomised to a prescription for exercise from a doctor plus behavioural counselling from a nurse.Main outcome measures Costs to the NHS and to participants. Comparison of costs with Roland-Morris disability score (number of activities impaired by pain), days in pain, and quality adjusted life years (QALYs). Comparison of NHS costs with QALY gain, using incremental cost effectiveness ratios and cost effectiveness acceptability curves.Results Intervention costs ranged from £30 for exercise prescription to £596 for 24 lessons in Alexander technique plus exercise. Cost of health services ranged from £50 for 24 lessons in Alexander technique to £124 for exercise. Incremental cost effectiveness analysis of single therapies showed that exercise offered best value (£61 per point on disability score, £9 per additional pain-free day, £2847 per QALY gain). For two-stage therapy, six lessons in Alexander technique combined with exercise was the best value (additional £64 per point on disability score, £43 per additional pain-free day, £5332 per QALY gain).Conclusions An exercise prescription and six lessons in Alexander technique alone were both more than 85% likely to be cost effective at values above £20 000 per QALY, but the Alexander technique performed better than exercise on the full range of outcomes. A combination of six lessons in Alexander technique lessons followed by exercise was the most effective and cost effective option. How does the Alexander Technique work? What are the authors findings about the clinical and cost effectiveness of the treatment? Watch this video to find out (12 mins). media-1 10.1136/bmj.a2656V1
Journal Article