scholarly journals Pulsed Shortwave Therapy in Cervical Osteoarthritis: An NSAID- Controlled, Randomized Clinical Trial

2020 ◽  
Author(s):  
Rachid El Mohameed ◽  
Sree Koneru ◽  
Richard Staelin ◽  
Kenneth McLeod ◽  
Omar Tabbouche ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Outcome Measures ◽  
Neck Disability Index ◽  
Primary Outcome Measure ◽  
Pain Medication ◽  
Secondary Outcome ◽  
Pain Duration ◽  
Cox 2 ◽  
Neck Disability ◽  
Pain At Rest

Abstract Objective Assess treatment superiority of Pulsed Shortwave Therapy (PSWT) against COX-2 NSAID therapy, in reducing disability and pain due to cervical osteoarthritis.Design 200chronic pain suffers (average pain duration about 2 years)diagnosed with cervical osteoarthritis by radiological imaging were randomized into one of two treatmentarms: COX-2 NSAID treatment: Etoricoxib 60mg/day for 4 weeks; or, PSWT treatmentworn 24 hours/day for 4 weeks. The primary outcome measure was the 4-week score on the Neck Disability Index (NDI): a 10-question assessment on a 50-point scale. Secondary outcome measures included pain(at rest and during activity)measured on a Visual Analog Scale (VAS)of0-100 mm, dose count of rescue pain medication (paracetamol)use and a treatment satisfaction rating. These 4-week scores were compared across the two arms to assess superiority.Results After 4 weeks of treatment,subjects in both study arms reported significantly lower (p<0.0001) 4-week measures (11.24-NSAID;9.34-PSWT; 0-50 points),VASrest (30.08-NSAID;22.76-PSWT; 0-100 mm) and VASactivity (36.40-NSAID; 27.42-PSWT; 0-100 mm).The absolute reduction from baseline in NDI was significantly greater in the PSWT arm than NSAID arm(by 3.66 points; 95% CI 2.3 to 5.02; p<0.0001). Similarly, the reductions from baseline inVASrest and VASactivitywere significantly greater in the PSWT arm than NSAID arm(by 10.89 mm;95% CI 6.90 to 14.87; p<0.0001 and 12.05 mm;95% CI 7.76 to 16.33; p<0.0001 respectively).The PSWT arm used 50% less rescue pain medication. Eleven adverse effects were reported in the NSAID arm and zero in the PSWT arm.Conclusion Both NSAID and PSWT treatments resulted in clinically meaningful increases in quality of life(NDI) and decreases in pain (VAS) associated with cervicalosteoarthritis. However, the PSWT armshowed superior improvements in all outcome measures when compared to the NSAID armwith no adverse effects.

scholarly journals Pulsed Shortwave Therapy in Cervical Osteoarthritis: an NSAID- Controlled, Randomized Clinical Trial

2021 ◽  
Author(s):  
A. Rachid El Mohammad ◽  
Sree Koneru ◽  
Richard Staelin ◽  
Kenneth McLeod ◽  
Omar Tabbouche ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Outcome Measures ◽  
Neck Disability Index ◽  
Primary Outcome Measure ◽  
Pain Medication ◽  
Secondary Outcome ◽  
Pain Duration ◽  
Cox 2 ◽  
Neck Disability ◽  
Pain At Rest

AbstractAssess treatment superiority of pulsed shortwave therapy (PSWT) against COX-2 NSAID therapy, in reducing disability and pain due to cervical osteoarthritis. Two hundred chronic pain suffers (average pain duration about 2 years) diagnosed with cervical osteoarthritis by radiological imaging were randomized into one of two treatment arms: COX-2 NSAID treatment; etoricoxib 60 mg/day for 4 weeks; or PSWT treatment worn 24 h/day for 4 weeks. The primary outcome measure was the 4-week score on the Neck Disability Index (NDI), a 10-question assessment on a 50-point scale. Secondary outcome measures included pain (at rest and during activity) measured on a visual analog scale (VAS) of 0–100 mm, dose count of rescue pain medication (paracetamol) use, and a treatment satisfaction rating. These 4-week scores were compared across the two arms to assess superiority. After 4 weeks of treatment, subjects in both study arms reported statistically significant (p < 0.0001) reductions in NDI, with final scores of 11.24-NSAID and 9.34-PSWT, VASrest, with final scores of 30.08-NSAID; 22.76-PSWT, and VASactivity, with final scores of 36.40-NSAID; 27.42-PSWT. The absolute reduction from baseline in NDI was significantly greater in the PSWT arm than NSAID arm (3.66 points; 95% CI 2.3 to 5.02; p < 0.0001). Similarly, the reductions from baseline in VASrest and VASactivity were significantly greater in the PSWT arm than NSAID arm (10.89 mm; 95% CI 6.90 to 14.87; p < 0.0001; and 12.05 mm; 95% CI 7.76 to 16.33; p < 0.0001, respectively). The PSWT arm used 50% less rescue pain medication. Eleven adverse effects were reported in the NSAID arm and zero in the PSWT arm. Both NSAID and PSWT treatments resulted in statistically significant improvements in quality of life (NDI) and reduction in pain (VAS) resulting from cervical osteoarthritis. However, the PSWT intervention showed superior improvements in all outcome measures when compared to the NSAID arm with no adverse effects. Clinicaltrials.gov (NCT03542955).

scholarly journals Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047341
Author(s):  
Caroline Marra ◽  
William J Gordon ◽  
Ariel Dora Stern
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Outcome Measures ◽  
Remote Monitoring ◽  
Search Algorithm ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Digital Products ◽  
Clinical Trial Registry ◽  
Before And After

ObjectivesIn an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic.DesignWe applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials.SettingAll trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021.Outcome measuresThe primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019–February 2020) compared with the 10 months following (May 2020–February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants).ResultsCDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19.ConclusionsThese findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants’ COVID-19 diagnosis.

scholarly journals Analgesic effects of intravenous ketamine after spinal anaesthesia for non-elective caesarean delivery: a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e044168
Author(s):  
Prahlad Adhikari ◽  
Asish Subedi ◽  
Birendra Prasad Sah ◽  
Krishna Pokharel
Keyword(s):  
Postoperative Pain ◽  
Adverse Effects ◽  
Outcome Measures ◽  
Caesarean Delivery ◽  
Low Dose ◽  
Saline Group ◽  
Secondary Outcome ◽  
Pain Scores ◽  
Intravenous Ketamine ◽  
Elective Caesarean Delivery

ObjectivesThis study aimed to determine if low dose intravenous ketamine is effective in reducing opioid use and pain after non-elective caesarean delivery.DesignProspective, randomised, double-blind.SettingTertiary hospital, Bisheshwar Prasad Koirala Institute of Health Sciences, Dharan, NepalParticipants80 patients undergoing non-elective caesarean section with spinal anaesthesia.InterventionsPatients were allocated in 1:1 ratio to receive either intravenous ketamine 0.25 mg/kg or normal saline before the skin incision.Primary and secondary outcome measuresThe primary outcome was the total amount of morphine equivalents needed up to postoperative 24 hours. Secondary outcome measures were postoperative pain scores, time to the first perception of pain, maternal adverse effects (nausea, vomiting, hypotension, shivering, diplopia, nystagmus, hallucination) and neonatal Apgar score at 1 and 5 min, neonatal respiratory depression and neonatal intensive-care referral.ResultsThe median (range) cumulative morphine consumption during the first 24 hours of surgery was 0 (0–4.67) mg in ketamine group and 1 (0–6) mg in saline group (p=0.003). The median (range) time to the first perception of pain was 6 (1–12) hours and 2 (0.5–6) hours in ketamine and saline group, respectively (p<0.001). A significant reduction in postoperative pain scores was observed only at 2 hours and 6 hours in the ketamine group compared with placebo group (p<0.05). Maternal adverse effects and neonatal outcomes were comparable between the two groups.ConclusionsIntravenous administration of low dose ketamine before surgical incision significantly reduced the opioid requirement in the first 24 hours in patients undergoing non-elective caesarean delivery.Trial registration numberNCT03450499.

Algorithm-Driven Pharmacological Management of Bipolar Disorder in Connecticut Prisons

2011 ◽  
Vol 57 (2) ◽  
pp. 251-264 ◽  
Author(s):  
Jayesh Kamath ◽  
Wanli Zhang ◽  
Karen Kesten ◽  
Sara Wakai ◽  
Deborah Shelton ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Outcome Measures ◽  
Clinical Status ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Type I ◽  
Symptom Scale ◽  
Pharmacological Management ◽  
Correctional Setting ◽  
Disorder Symptom

The objective of this study was to assess adaptation of the Texas Implementation of Medication Algorithm (TIMA) for bipolar disorder (BD) in the Connecticut Department of Correction. A nonrandomized sample of 20 males and 20 females, with diagnoses of BD Type I or II, was enrolled in the study. Two TIMA-trained psychiatrists treated the participants over a 12-week period following the TIMA protocol. The primary outcome measure was the Bipolar Disorder Symptom Scale. Secondary outcome measures evaluated global clinical status, comorbid symptomatology, and quality of life. Significant improvement was seen with the primary and secondary outcome measures ( p < .001). Subanalyses showed differences in outcomes based on gender and whether a manic or depression algorithm was used. Antidepressant and antipsychotic medication use decreased, with increase in anticonvulsant and anxiolytic medication usage. This pilot study confirmed the effectiveness and benefits of TIMA for BD adaptation in the correctional setting.

Balloon Eustachian tuboplasty treatment of longstanding Eustachian tube dysfunction

2017 ◽  
Vol 131 (7) ◽  
pp. 614-619 ◽  
Author(s):  
T Singh ◽  
V Taneja ◽  
K Kulendra ◽  
M Farr ◽  
J Robinson ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Eustachian Tube ◽  
Balloon Dilation ◽  
Primary Outcome Measure ◽  
Eustachian Tube Dysfunction ◽  
Secondary Outcome ◽  
Tube Dysfunction ◽  
Previously Treated ◽  
Objective Outcomes ◽  
Balloon Eustachian Tuboplasty

AbstractBackground:Eustachian tube dysfunction is a poorly defined condition associated with various symptoms and it can predispose to middle-ear disease. Balloon dilation Eustachian tuboplasty has been proposed as a treatment for Eustachian tube dysfunction.Objective:To evaluate the subjective and objective outcomes of balloon dilation Eustachian tuboplasty in patients with recurrent, previously treated chronic Eustachian tube dysfunction.Methods:The study was conducted on 11 patients (13 ears) who had undergone previous unsuccessful medical and surgical treatment. Tympanometry was the primary outcome measure. Secondary outcome measures included pure tone audiogram assessment and seven-item Eustachian Tube Dysfunction Questionnaire score.Results:Balloon dilation Eustachian tuboplasty resulted in significant improvements in 11 patients’ subjective but not objective outcome measures.Conclusion:The objective abnormality and subjective symptoms in Eustachian tube dysfunction may represent two distinct pathological processes, which may nevertheless influence and exacerbate each other.

Cervical radiofrequency neurotomy in patients with chronic whiplash: a study of multiple outcome measures

2006 ◽  
Vol 4 (5) ◽  
pp. 365-373 ◽  
Author(s):  
Tamara Prushansky ◽  
Evgeny Pevzner ◽  
Carlos Gordon ◽  
Zeevi Dvir
Keyword(s):  
Outcome Measures ◽  
Whiplash Injury ◽  
Neck Disability Index ◽  
Pressure Pain Threshold ◽  
Self Report ◽  
Radiofrequency Neurotomy ◽  
Symptom Check List ◽  
Chronic Whiplash ◽  
Neck Disability ◽  
Rate Of Success

Object Cervical radiofrequency neurotomy (CRFN) is used in the treatment of patients with chronic pain and disability due to whiplash injury. Confirmation of its efficiency has, however, been based solely on pain and psychological distress factors. The aim of the present study was to extend the assessment of CRFN efficacy by adding other outcome measures to shed light on neuromotor-functional-psychological interactions by undertaking comparison of pre- and 1-year postintervention data. Methods Forty patients with chronic whiplash injury–associated disorders were evaluated prior to and at two separate sessions after CRFN. The evaluation included Neck Disability Index, cervical range of motion, isometric cervical muscle strength, cervical pressure pain threshold, Symptom Check List–90-Revised, and subjective Self-Report of Improvement (SRI). The authors found that the CRFN had a significantly positive effect on all measured parameters. A case-by-case analysis revealed improvement in 70% of the patients at the final follow-up examination. Using stringent cutoff values, between 30 and 60% of the patients experienced measurable improvement. Evaluation of SRI results indicated that more than 80% of the patients were satisfied with the procedure. Conclusions Approximately 1 year after intervention, CRFN was associated with an acceptable rate of success, as reflected by objective and subjective outcome measures.

scholarly journals Combining Lovastatin and Minocycline for the Treatment of Fragile X Syndrome: Results From the LovaMiX Clinical Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Camille Champigny ◽  
Florence Morin-Parent ◽  
Laurence Bellehumeur-Lefebvre ◽  
Artuela Çaku ◽  
Jean-François Lepage ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Fragile X Syndrome ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Fragile X ◽  
Combined Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Global Score

Background: Limited success of previous clinical trials for Fragile X syndrome (FXS) has led researchers to consider combining different drugs to correct the pleiotropic consequences caused by the absence of the Fragile X mental retardation protein (FMRP). Here, we report the results of the LovaMiX clinical trial, the first trial for FXS combining two disease-modifying drugs, lovastatin, and minocycline, which have both shown positive effects when used independently.Aim: The main goals of the study were to assess the safety and efficacy of a treatment combining lovastatin and minocycline for patients with FXS.Design: Pilot Phase II open-label clinical trial. Patients with a molecular diagnostic of FXS were first randomized to receive, in two-step titration either lovastatin or minocycline for 8 weeks, followed by dual treatment with lovastatin 40 mg and minocycline 100 mg for 2 weeks. Clinical assessments were performed at the beginning, after 8 weeks of monotherapy, and at week 20 (12 weeks of combined therapy).Outcome Measures: The primary outcome measure was the Aberrant Behavior Checklist-Community (ABC-C) global score. Secondary outcome measures included subscales of the FXS specific ABC-C (ABC-CFX), the Anxiety, Depression, and Mood Scale (ADAMS), the Social Responsiveness Scale (SRS), the Behavior Rating Inventory of Executive Functions (BRIEF), and the Vineland Adaptive Behavior Scale second edition (VABS-II).Results: Twenty-one individuals out of 22 completed the trial. There were no serious adverse events related to the use of either drugs alone or in combination, suggesting good tolerability and safety profile of the combined therapy. Significant improvement was noted on the primary outcome measure with a 40% decrease on ABC-C global score with the combined therapy. Several outcome measures also showed significance.Conclusion: The combination of lovastatin and minocycline is safe in patients for FXS individuals and appears to improve several elements of the behavior. These results set the stage for a larger, placebo-controlled double-blind clinical trial to confirm the beneficial effects of the combined therapy.

scholarly journals Reduced physical activity and weight gain are associated with an increase of depressive symptoms during the COVID-19 pandemic. A general practitioners’ prospective observational study

2021 ◽  
Vol 10 ◽  
pp. 204800402110477
Author(s):  
Simon Wernhart ◽  
Eberhard Weihe ◽  
Tienush Rassaf
Keyword(s):  
Physical Activity ◽  
Depressive Symptoms ◽  
Weight Gain ◽  
Observational Study ◽  
General Practitioners ◽  
Outcome Measures ◽  
Prospective Observational Study ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Reduced Physical Activity

Objectives We aimed to assess associations between depressive symptoms, lifestyle, and somatic symptoms during the COVID-19 pandemic. Design A prospective, observational study using a self-designed questionnaire. Setting Three general practitioners’ (GP) offices in rural Germany. Participants 271 adult patients without manifest cardiovascular or pulmonary disease with (n = 82) and without (n = 189) hypertension reporting to our GP offices. Main outcome measures The reported increase of depressive symptoms (loneliness, sleeplessness, joylessness, listlessness) prior to the first documented case in Germany on 27.01.2020 (t0) as opposed to patients’ health perception during the Corona pandemic (t1) was the primary outcome measure. The secondary outcome measures were changes in physical activity (PA), dyspnea and angina in the two groups. Results Out of 271 patients (50.8 ± 16.8 years, 55.1% females), 1.5% were tested positive for COVID-19. Overall, listlessness (8.5%, p = 0.001), sleeplessness (5.2%, p = 0.001) and joylessness (4.2%, p = 0.003) were increased. Dyspnea significantly increased (9.2%, p < 0.001) and employment status worsened (6.5%, p < 0.001). There were significant associations between the increase of depressive symptoms, weight increase (p = 0.017), and reduction in physical activity (p = 0.046). However, after adjusting for age, hypertensive patients did not show more depressive symptoms (p = 0.704), dyspnea (p = 0.063) or angina (p = 0.432), nor was there any difference in PA (p = 0.906) compared to healthy individuals. Conclusions We demonstrate an association between the deterioration of depressive symptoms, weight gain, and reduced physical activity during COVID-19, both in hypertensives and healthy controls. Hypertension is no driver of symptom deterioration during the pandemic. The trial was registered in the German Clinical Trials Registry (DRKS00022157).

Tinnitus Management: Randomized Controlled Trial Comparing Extended-Wear Hearing Aids, Conventional Hearing Aids, and Combination Instruments

2017 ◽  
Vol 28 (06) ◽  
pp. 546-561 ◽  
Author(s):  
James A. Henry ◽  
Garnett McMillan ◽  
Serena Dann ◽  
Keri Bennett ◽  
Susan Griest ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Hearing Aids ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Point Reduction ◽  
Clinically Significant

Background: Whereas hearing aids have long been considered effective for providing relief from tinnitus, controlled clinical studies evaluating this premise have been very limited. Purpose: The purpose of this study was to systematically determine the relative efficacy of conventional receiver-in-the-canal hearing aids (HA), the same hearing aids with a sound generator (HA+SG), and extended-wear, deep fit hearing aids (EWHA), to provide relief from tinnitus through a randomized controlled trial. Each of these ear-level devices was a product of Phonak, LLC. Research Design: Participants were randomized to HA, HA+SG, or EWHA and wore bilaterally fit devices for about 4 months. Fittings, adjustments, and follow-up appointments were conducted to comply with company guidelines and to ensure that all participants attended appointments on the same schedule. At 4–5 months, participants returned to complete final outcome measures, which concluded their study participation. Study Sample: Participants were 55 individuals (mean age: 63.1 years) with mild to moderately-severe hearing loss who: (a) did not currently use hearing aids; (b) reported tinnitus that was sufficiently bothersome to warrant intervention; and (c) were suitable candidates for each of the study devices. Data Collection and Analysis: The primary outcome measure was the Tinnitus Functional Index (TFI). Secondary outcome measures included hearing-specific questionnaires and the Quick Speech in Noise test (QuickSIN). The goal of the analysis was to evaluate efficacy of the EWHA and HA+SG devices versus the HA standard device. Results: There were 18 participants in each of the HA and EWHA groups and 19 in the HA+SG group. Gender, age, and baseline TFI severity were balanced across treatment groups. Nearly all participants had a reduction in tinnitus symptoms during the study. The average TFI change (improvement) from baseline was 21 points in the HA group, 31 points in the EWHA group, and 33 points in the HA+SG group. A “clinically significant” improvement in reaction to tinnitus (at least 13-point reduction in TFI score) was seen by 67% of HA, 82% of EWHA, and 79% of HA+SG participants. There were no statistically significant differences in the extent to which the devices reduced TFI scores. Likewise, the hearing-specific questionnaires and QuickSIN showed improvements following use of the hearing aids but these improvements did not differ across device groups. Conclusions: There is insufficient evidence to conclude that any of these devices offers greater relief from tinnitus than any other one tested. However, all devices appear to offer some improvement in the functional effects of tinnitus.

scholarly journals 188 The Use of a Group Based Upper Limb Programme in Improving Outcome in Acute Stroke Rehabilitation

2019 ◽  
Vol 48 (Supplement_3) ◽  
pp. iii17-iii65
Author(s):  
Kerri Donnelly ◽  
Enya Mulcahy ◽  
Catherine Merrick ◽  
Orla Fitzgerald
Keyword(s):  
Acute Stroke ◽  
Grip Strength ◽  
Outcome Measures ◽  
Upper Limb ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Dominant Hand ◽  
Nine Hole Peg Test

Abstract Background After a stroke 85% of patients experience altered arm function. Current research demonstrates that increasing upper limb rehabilitation results in improved outcomes (Ward et al., 2019). The Graded Repetitive Arm Supplementary Programme (GRASP) group is an established adjunctive therapy in the stroke service. The group provides additional therapy for suitable patients with upper extremity deficits. The group is run jointly by a physiotherapist and an occupational therapist. Patients attend twice weekly for a one hour period in addition to their regular therapy. The GRASP group consists of 3 levels of varying abilities and patients are categorised by their Fugl-Meyer score. Methods A prospective audit was completed in 2019 and data was collected using a word document and excel spread sheet. Standardised outcome measures were completed on admission and discharge to establish upper limb ability. The primary outcome measure was the Fugl-Meyer and the secondary outcome measures were the nine hole peg test and grip strength using the Dynamometer. Results 12 patients attended the GRASP group over this period. 75% were males. The average age was 76 years with the age range from 48-95 years. 58% of patients experienced upper limb weakness in their non-dominant hand. Post intervention data was not obtained for 5 patients due to unforeseeable discharge from the acute setting. Preliminary data to date shows that our primary outcome measure improved in 86% of patients with increases ranging from 2-11 points on the Fugl-Meyer score (Minimally Clinical Important Difference =5points). Our secondary outcome measures demonstrated patients had no change (28%) or an improvement (72%) in grip strength and 100% of patients improved on the time taken to complete the nine hole peg test. Conclusion The GRASP group was found to be effective in improving upper limb outcome measures in an acute stroke inpatient hospital setting.

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