scholarly journals Controlled study of the efficacy ozone therapy in Fibromyalgia, a randomised controlled trial [abstract]

2019 ◽  
Vol 3 (4) ◽  
Author(s):  
Ziad Fahmy
Keyword(s):  
Local Anaesthetic ◽  
Controlled Trial ◽  
Vital Signs ◽  
Joint Stiffness ◽  
Chronic Widespread Pain ◽  
Ozone Treatment ◽  
Controlled Study ◽  
Randomised Controlled ◽  
Nsaid Consumption ◽  
Core Features

INTRODUCTION: Fibromyalgia meaning muscle and connective tissue pain it a disorder classified by the presence of chronic widespread pain and a heightened and painful response to gentle touch (tender points). Other core features of the disorder include debilitating fatigue, sleep disturbance, and joint stiffness. PURPOSE: The aim of the study is to see the efficacy of ozone in relation to other local anaesthetic and placebo for relief of pain. MATERIAL AND METHODS: The Study involved 300 patients with classical Fibromyalgia (ACR criteria) age between 45 and 70. The first group treated only with ozone 2 - 3 x per week for over 4 necks (15 mcgr/mL) The second group with local anaesthetic /Lidocain 2 % 10- 20 mL) The third group, placebo. Several clinical parameters were monitored during a demonstration in 4-6 weeks. The clinical examination included vital signs, pain using visual analog Scale, Duration of morning stiffness, night pain, NSAID consumption RESULTS AND CONCLUSION: 1.- Ozone has significant effect in Fibromyalgia in relation to the other two groups. 2.- Function index improved in both groups ozone and anaesthetic. 3.- Ozone treatment is a safe therapy compared to the local anaesthetic.

scholarly journals Pain Levels after Local Anaesthetic with or without Hyaluronidase in Carpal Tunnel Release: A Randomised Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-4 ◽  
Author(s):  
G. Yeo ◽  
A. Gupta ◽  
G. Ding ◽  
H. Skerman ◽  
M. Khatun ◽  
...  
Keyword(s):  
Carpal Tunnel ◽  
Local Anaesthetic ◽  
Controlled Trial ◽  
Carpal Tunnel Release ◽  
Controlled Study ◽  
Control Group ◽  
Vas Scores ◽  
Randomised Controlled ◽  
Anaesthetic Injection ◽  
Local Anaesthetic Injection

Purpose. Hyaluronidase is an enzyme that temporarily liquefies the interstitial barrier, allowing easy dispersal of local anaesthetic through cleavage of tissue planes. This prospective, blinded, randomised controlled study investigates the utility of adding hyaluronidase to local anaesthetic in the setting of carpal tunnel release.Methods. 70 consecutive carpal tunnel release patients were recruited and randomised into a control group only receiving local anaesthetic and a hyaluronidase group receiving both hyaluronidase and local anaesthetic. Pain scores were rated using the visual analogue scale (VAS) by patients immediately after local anaesthetic injection and again immediately after the carpal tunnel release.Results. Preoperative VAS scores, taken after local anaesthetic injection, were greater than postoperative VAS scores. Postoperative VAS scores were significantly lower in the hyaluronidase group and tourniquet times were significantly shorter in the hyaluronidase group.Conclusion. Hyaluronidase addition to local anaesthetic in carpal tunnel release resulted in significant reductions in operative time and pain immediately after operation.

scholarly journals Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041500
Author(s):  
Zoe Menczel Schrire ◽  
Craig L Phillips ◽  
Shantel L Duffy ◽  
Nathaniel S Marshall ◽  
Loren Mowszowski ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Blood Pressure ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Controlled Study ◽  
Brain Oxidative Stress ◽  
Randomised Controlled

IntroductionMelatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).Methods and analysisThe study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.Ethics and disseminationThis protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).Protocol versionV.8 15 October 2020.

scholarly journals Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016966 ◽  
Author(s):  
Sarah Thomas ◽  
Louise Fazakarley ◽  
Peter W Thomas ◽  
Sarah Collyer ◽  
Sarah Brenton ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Well Being ◽  
Recruitment Rate ◽  
Controlled Study ◽  
Activity Levels ◽  
Nintendo Wii ◽  
Serious Adverse Events ◽  
Randomised Controlled

ObjectivesWhile the health and well-being benefits of physical activity are recognised, people with multiple sclerosis (MS) often face greater barriers than the general population. The Nintendo Wii potentially offers a fun, convenient way of overcoming some of these. The aim was to test the feasibility of conducting a definitive trial of the effectiveness and cost-effectiveness of Mii-vitaliSe; a home-based, physiotherapist-supported Nintendo Wii intervention.DesignA single-centre wait-list randomised controlled study.SettingMS service in secondary care.ParticipantsAmbulatory, relatively inactive people with clinically confirmed MS.InterventionThirty participants were randomised to receive Mii-vitaliSe either immediately (for 12 months) or after a 6-month wait (for 6 months). Mii-vitaliSe consisted of two supervised Nintendo Wii familiarisation sessions in the hospital followed by home use (Wii Sports, Sports Resort and Fit Plus software) with physiotherapist support and personalised resources.OutcomesIncluded self-reported physical activity levels, quality of life, mood, self-efficacy, fatigue and assessments of balance, gait, mobility and hand dexterity at baseline, 6 and 12 months. Interviews (n=25) explored participants’ experiences and, at study end, the two Mii-vitaliSe facilitators’ experiences of intervention delivery (main qualitative findings reported separately).ResultsMean (SD) age was 49.3 (8.7) years, 90% female, with 47% diagnosed with MS <6 years ago and 60% new to active gaming. The recruitment rate was 31% (95% CI 20% to 44%). Outcome data were available for 29 (97%) at 6 months and 28 (93%) at 12 months. No serious adverse events were reported during the study. Qualitative data indicated that Mii-vitaliSe was well-received. Mean Wii use across both groups over the initial 6-month intervention period was twice a week for 27 min/day. Mean cost of delivering Mii-vitaliSe was £684 per person.DiscussionMii-vitaliSe appears acceptable and a future trial feasible and warranted. These findings will inform its design.Trial registrationISRCTN49286846

Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial

Perfusion ◽  
2017 ◽  
Vol 32 (7) ◽  
pp. 591-597 ◽  
Author(s):  
Geoff G. Lockwood ◽  
Leilani Cabreros ◽  
Dorota Banach ◽  
Prakash P. Punjabi
Keyword(s):  
Cardiac Surgery ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Subcutaneous Infusion ◽  
Randomised Controlled Study ◽  
Randomised Controlled

Background: Continuous bilateral thoracic paravertebral blockade has been used for analgesia after cardiac surgery, but its efficacy has never been formally tested. Method: Fifty adult patients were enrolled in a double-blind, randomised, controlled study of continuous bilateral thoracic paravertebral infusion of 0.5% lidocaine (1 mg.kg-1.hr-1) for analgesia after coronary surgery. Control patients received a subcutaneous infusion of lidocaine at the same rate through catheters inserted at the same locations as the study group. The primary outcome was morphine consumption at 48 hours using patient-controlled analgesia (PCA). Secondary outcomes included pain, respiratory function, nausea and vomiting. Serum lidocaine concentrations were measured on the first two post-operative days. Results: There was no difference in morphine consumption or in any other outcome measure between the groups. Serum lidocaine concentrations increased during the study, with a maximum of 5.9 mg.l-1. There were no adverse events as a consequence of the study. Conclusion: Bilateral paravertebral infusion of lidocaine confers no advantage over systemic lidocaine infusion after cardiac surgery. Clinical trial registration: ISRCTN13424423 ( https://www.isrctn.com )

Controlled Study of the Use of Local Steroid Injection in the Treatment of Trigger Finger and Thumb

1992 ◽  
Vol 17 (1) ◽  
pp. 69-70 ◽  
Author(s):  
M. A. LAMBERT ◽  
R. J. MORTON ◽  
J. P. SLOAN
Keyword(s):  
Local Anaesthetic ◽  
Steroid Injection ◽  
Controlled Trial ◽  
Trigger Finger ◽  
Controlled Study ◽  
Control Group ◽  
Methylprednisolone Acetate ◽  
Double Blind ◽  
Local Steroid Injection ◽  
Control Injection

A controlled double-blind prospective study of injection of methylprednisolone acetate plus local anaesthetic against a control injection of a local anaesthetic in the treatment of trigger finger and thumb has shown a 60% success rate for the steroid injection against 16% for the control group (p < 0.05). This is the first controlled trial of local steroid therapy in this condition.

A Controlled Trial of Home-Based Acute Psychiatric Services

1993 ◽  
Vol 163 (1) ◽  
pp. 49-54 ◽  
Author(s):  
Tom Burns ◽  
Alan Beadsmoore ◽  
Ashok V. Bhat ◽  
Andrew Oliver ◽  
Carola Mathers
Keyword(s):  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Community Based ◽  
Home Based ◽  
Randomised Controlled Study ◽  
One Year ◽  
Randomised Controlled ◽  
Clinical Measures ◽  
Experimental Group

While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).

scholarly journals Repeat assessment of examination signs among children in Malawi with fast-breathing pneumonia

2020 ◽  
Vol 6 (2) ◽  
pp. 00275-2019
Author(s):  
Jennifer L. Lenahan ◽  
Evangelyn Nkwopara ◽  
Melda Phiri ◽  
Tisungane Mvalo ◽  
Mari T. Couasnon ◽  
...  
Keyword(s):  
Placebo Group ◽  
Randomised Controlled Trial ◽  
Physical Examination ◽  
Controlled Trial ◽  
Arterial Oxygen Saturation ◽  
Vital Signs ◽  
Arterial Oxygen ◽  
Support Providers ◽  
Randomised Controlled ◽  
Repeat Assessment

BackgroundAs part of a randomised controlled trial of treatment with placebo versus 3 days of amoxicillin for nonsevere fast-breathing pneumonia among Malawian children aged 2–59 months, a subset of children was hospitalised for observation. We sought to characterise the progression of fast-breathing pneumonia among children undergoing repeat assessments to better understand which children do and do not deteriorate.MethodsVital signs and physical examination findings, including respiratory rate, arterial oxygen saturation measured by pulse oximetry (SpO2), chest indrawing and temperature were assessed every 3 h for the duration of hospitalisation. Children were assessed for treatment failure during study visits on days 1, 2, 3 and 4.ResultsHospital monitoring data from 436 children were included. While no children had SpO2 90–93% at baseline, 7.4% (16 of 215) of children receiving amoxicillin and 9.5% (21 of 221) receiving placebo developed SpO2 90–93% during monitoring. Similarly, no children had chest indrawing at enrolment, but 6.6% (14 of 215) in the amoxicillin group and 7.2% (16 of 221) in the placebo group went on to develop chest indrawing during hospitalisation.ConclusionRepeat monitoring of children with fast-breathing pneumonia identified vital and physical examination signs not present at baseline, including SpO2 90–93% and chest indrawing. This information may support providers and policymakers in developing guidance for care of children with nonsevere pneumonia.

scholarly journals Effects of nasal lavage with and without mupirocin after endoscopic endonasal skull base surgery: a randomised, controlled study

2019 ◽  
Vol 133 (12) ◽  
pp. 1059-1063
Author(s):  
B H K Ng ◽  
I P Tang ◽  
P Narayanan ◽  
R Raman ◽  
R L Carrau
Keyword(s):  
Skull Base ◽  
Skull Base Surgery ◽  
Controlled Trial ◽  
Nasal Lavage ◽  
Nasal Endoscopy ◽  
Controlled Study ◽  
Endoscopic Endonasal ◽  
Randomised Controlled Study ◽  
Skull Base Lesions ◽  
Randomised Controlled

AbstractBackgroundNasal lavage with mupirocin has the potential to reduce sinonasal morbidity in endoscopic endonasal approaches for skull base surgery.ObjectiveTo evaluate the effects of nasal lavage with and without mupirocin after endoscopic endonasal skull base surgery.MethodsA pilot randomised, controlled trial was conducted on 20 adult patients who had undergone endoscopic endonasal approaches for skull base lesions. These patients were randomly assigned to cohorts using nasal lavages with mupirocin or without mupirocin. Patients were assessed in the out-patient clinic, one week and one month after surgery, using the 22-item Sino-Nasal Outcome Test questionnaire and nasal endoscopy.ResultsPatients in the mupirocin nasal lavage group had lower nasal endoscopy scores post-operatively, and a statistically significant larger difference in nasal endoscopy scores at one month compared to one week. The mupirocin nasal lavage group also showed better Sino-Nasal Outcome Test scores at one month compared to the group without mupirocin.ConclusionNasal lavage with mupirocin seems to yield better outcomes regarding patients’ symptoms and endoscopic findings.

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