Developing and Validating a Sham Acupuncture Needle

Objectives To develop a sham needle device and test its credibility as a control for acupuncture when used in a randomised controlled trial of myofascial trigger point needling in patients with whiplash associated pain. Methods Sham needles were developed by blunting true acupuncture needles. Whiplash injured patients (<16 weeks duration) were randomly allocated to receive either true acupuncture or the “placebo” sham needle control. The true and sham needling interventions were delivered using the same standardised procedure. Patients were informed that they would receive either real or placebo needles, and asked (i) to state which treatment they believed they had received (treatment belief); (ii) to complete the four item Borkovec and Nau self-assessment credibility scale. Results were compared between groups and the analysis explored whether a patient's previous experience of acupuncture was related to their treatment belief. Other outcomes of the study will be reported elsewhere. Results 20 patients received the true acupuncture and 21 received the sham. There was no significant difference between the treatment beliefs of the two groups (χ 2 = 1.51; p>0.2) nor in the mean item scores on the Borkovec and Nau credibility scale (t test, p values ranged from 0.38 to 0.87). Of the patients in the sham acupuncture group who had previous experience of acupuncture, none recorded receiving the sham intervention. Conclusion Within the context of this pilot study, the sham acupuncture intervention was found to be a credible control for acupuncture. This supports its use in a planned, definitive, randomised controlled trial on a similar whiplash injured population.

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Acupuncture for the Treatment of Oculomotor Paralysis: A Pilot Randomised Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2016/3961450 ◽

2016 ◽

Vol 2016 ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

Jia-Qi Bi ◽

Wei Li ◽

Qi Yang ◽

Bao-lin Li ◽

Qing-Gang Meng ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Adverse Events ◽

Response Rate ◽

Controlled Trial ◽

Sham Acupuncture ◽

Acupuncture Group ◽

Secondary Outcome ◽

Palpebral Fissure ◽

Significant Difference ◽

Randomised Controlled

This study consisted of a single centre randomised controlled trial with two parallel arms: an acupuncture group (n=20) with 27 affected eyes and a sham group (n=20) with 23 affected eyes. Participants in the acupuncture group received acupuncture treatment once daily, three times weekly for four weeks. Participants assigned to the control group received sham acupuncture, the same protocol as that used for the acupuncture group but without insertion of needles into the skin. The primary outcome measure was the cervical range of motion (CROM) score. Secondary outcome measures were the palpebral fissure size, response rate, and adverse events. All 40 participants completed the study. In the comparison of acupuncture and sham acupuncture, a significant difference was observed between acupuncture and sham acupuncture in CROM score (21.37±15.16and32.21±19.54, resp.) (P<0.05) and palpebral fissure size (7.19±2.94and5.41±2.45, resp.) (P<0.05). Response rate was also significantly different in the acupuncture group (P<0.05). No adverse events were reported in both groups in this study. In summary, it was demonstrated that acupuncture had a feasibility positive effect on oculomotor paralysis.

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Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

Hip International ◽

10.1177/11207000211005762 ◽

2021 ◽

pp. 112070002110057

Author(s):

Niels H Bech ◽

Inger N Sierevelt ◽

Sheryl de Waard ◽

Boudijn S H Joling ◽

Gino M M J Kerkhoffs ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Femoroacetabular Impingement ◽

Hip Arthroscopy ◽

Controlled Trial ◽

Poor Quality ◽

Control Group ◽

Treatment Groups ◽

Significant Difference ◽

Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

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The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults

Nutrients ◽

10.3390/nu13031042 ◽

2021 ◽

Vol 13 (3) ◽

pp. 1042

Author(s):

Nicholas Phillips ◽

Julie Mareschal ◽

Nathalie Schwab ◽

Emily Manoogian ◽

Sylvie Borloz ◽

...

Keyword(s):

Weight Loss ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Smartphone Application ◽

Metabolic Health ◽

Dietary Advice ◽

Processed Food ◽

Significant Difference ◽

Randomised Controlled ◽

Pragmatic Randomised Controlled Trial

Weight loss is key to controlling the increasing prevalence of metabolic syndrome (MS) and its components, i.e., central obesity, hypertension, prediabetes and dyslipidaemia. The goals of our study were two-fold. First, we characterised the relationships between eating duration, unprocessed and processed food consumption and metabolic health. During 4 weeks of observation, 213 adults used a smartphone application to record food and drink consumption, which was annotated for food processing levels following the NOVA classification. Low consumption of unprocessed food and low physical activity showed significant associations with multiple MS components. Second, in a pragmatic randomised controlled trial, we compared the metabolic benefits of 12 h time-restricted eating (TRE) to standard dietary advice (SDA) in 54 adults with an eating duration > 14 h and at least one MS component. After 6 months, those randomised to TRE lost 1.6% of initial body weight (SD 2.9, p = 0.01), compared to the absence of weight loss with SDA (−1.1%, SD 3.5, p = 0.19). There was no significant difference in weight loss between TRE and SDA (between-group difference −0.88%, 95% confidence interval −3.1 to 1.3, p = 0.43). Our results show the potential of smartphone records to predict metabolic health and highlight that further research is needed to improve individual responses to TRE such as a shorter eating window or its actual clock time.

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Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial

PLoS ONE ◽

10.1371/journal.pone.0241704 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0241704

Author(s):

Jennifer Wild ◽

Shama El-Salahi ◽

Michelle Degli Esposti ◽

Graham R. Thew

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Self Report ◽

Post Traumatic Stress ◽

Emergency Responders ◽

Significant Difference ◽

Randomised Controlled ◽

Resilience Intervention

Background Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders’ wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers. Methods We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind’s group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions. Results A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure. Conclusions The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health. Trial registration ISRCTN registry, ISRCTN79407277.

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Email-based promotion of self-help for subthreshold depression: Mood Memos randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.111.101394 ◽

2012 ◽

Vol 200 (5) ◽

pp. 412-418 ◽

Cited By ~ 43

Author(s):

Amy J. Morgan ◽

Anthony F. Jorm ◽

Andrew J. Mackinnon

Keyword(s):

Major Depression ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Active Group ◽

Depression Symptoms ◽

Number Needed To Treat ◽

Subthreshold Depression ◽

Self Help ◽

Significant Difference ◽

Randomised Controlled

BackgroundSubthreshold depression is common, impairs functioning and increases the risk of major depression. Improving self-help coping strategies could help subthreshold depression and prevent major depression.AimsTo test the effectiveness of an automated email-based campaign promoting self-help behaviours.MethodA randomised controlled trial was conducted through the website: www.moodmemos.com. Participants received automated emails twice weekly for 6 weeks containing advice about self-help strategies. Emails containing general information about depression served as a control. The principal outcome was depression symptom level on the nine-item Patient Health Questionnaire (PHQ-9) (trial registration: ACTRN12609000925246).ResultsThe study recruited 1326 adults with subthreshold depression. There was a small significant difference in depression symptoms at post-intervention, favouring the active group (d = 0.17, 95% CI 0.01–0.34). There was a lower, although non-significant, risk of major depression in the active group (number needed to treat (NNT) 25, 95% CI 11 to ∞ to NNT(harm) 57).ConclusionsEmails promoting self-help strategies were beneficial. Internet delivery of self-help messages affords a low-cost, easily disseminated and highly automated approach for indicated prevention of depression.

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Abstract TP233: Are Baseline Characteristics of Stroke Patients Included Into an Observational Study Similar to Patients Included Into a Randomised Controlled Trial?

Stroke ◽

10.1161/str.47.suppl_1.tp233 ◽

2016 ◽

Vol 47 (suppl_1) ◽

Author(s):

Anna Schulte ◽

Falko Jürries ◽

Anna Messerschmid ◽

Nico Behnke ◽

Jan Liman ◽

...

Keyword(s):

Atrial Fibrillation ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Stroke Severity ◽

Stroke Patients ◽

Exclusion Criteria ◽

Observational Trial ◽

Significant Difference ◽

Baseline Characteristics ◽

Randomised Controlled

Introduction: Undiagnosed atrial fibrillation (UAF) is a major burden in ischemic stroke. However, randomised trials have partly shown astonishingly low AF detection rates (e. g. in the CRYSTAL-AF study). This may be due to differences in baseline and stroke characteristics between studies. Hypothesis: We hypothesized that stroke patients in a randomised controlled trial have less severe strokes than patients in an observational trial with similar inclusion and exclusion criteria. Methods: We used data from the Find-AF observational (NCT 01855035) and the Find-AF randomised controlled trial (ISRCTN 46104198). We included only patients at study site Goettingen of the Find-AF randomised controlled trial (n=153) and only included patients from the Find-AF observational trial that fulfilled the inclusion/exclusion criteria of Find-AF randomised (n=90). We compared baseline characteristics of screened versus included patients in Find-AF randomised and baseline characteristics and stroke severity parameters between both studies. Data are shown as mean (Standard Deviation) or Median (25%; 75% percentile) and were compared by chi-square, t-test or Mann-Whitney U test. Results: Table 1 shows as comparison between baseline characteristics of both studies Comparing patients fulfilling the inclusion/exclusion criteria of Find-AF randomised, but unwilling to give informed consent to randomised patients showed a significant difference in age (77 ± 11 vs. 74 ± 8; p< 0.001), but no difference in gender (p=0.581). Conclusions: Both studies included patients similar in age, gender and many comorbidities. Major differences occurred in NIHSS and MRS. As NIHSS is a predictor of atrial fibrillation, randomized controlled trials investigating AF detection should include a minimum NIHSS to avoid a selection bias towards less severe strokes.

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Contamination and washing of cloth masks and risk of infection among hospital health workers in Vietnam: a post hoc analysis of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042045 ◽

2020 ◽

Vol 10 (9) ◽

pp. e042045

Author(s):

Chandini Raina MacIntyre ◽

Tham Chi Dung ◽

Abrar Ahmad Chughtai ◽

Holly Seale ◽

Bayzidur Rahman

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Poor Performance ◽

Full Time ◽

Risk Of Infection ◽

Viral Contamination ◽

Post Hoc Analysis ◽

Significant Difference ◽

Randomised Controlled ◽

Post Hoc

BackgroundIn a previous randomised controlled trial (RCT) in hospital healthcare workers (HCWs), cloth masks resulted in a higher risk of respiratory infections compared with medical masks. This was the only published RCT of cloth masks at the time of the COVID-19 pandemic.ObjectiveTo do a post hoc analysis of unpublished data on mask washing and mask contamination from the original RCT to further understand poor performance of the two-layered cotton cloth mask used by HCWs in that RCT.Setting14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam.ParticipantsA subgroup of 607 HCWs aged ≥18 years working full time in selected high-risk wards, who used a two-layered cloth mask and were part of a randomised controlled clinical trial comparing medical masks and cloth masks.InterventionWashing method for cloth masks (self-washing or hospital laundry). A substudy of contamination of a sample of 15 cloth and medical masks was also conducted.Outcome measureInfection rate over 4 weeks of follow up and viral contamination of masks tested by multiplex PCR.ResultsViral contamination with rhinovirus was identified on both used medical and cloth masks. Most HCW (77% of daily washing) self-washed their masks by hand. The risk of infection was more than double among HCW self-washing their masks compared with the hospital laundry (HR 2.04 (95% CI 1.03 to 4.00); p=0.04). There was no significant difference in infection between HCW who wore cloth masks washed in the hospital laundry compared with medical masks (p=0.5).ConclusionsUsing self-reported method of washing, we showed double the risk of infection with seasonal respiratory viruses if masks were self-washed by hand by HCWs. The majority of HCWs in the study reported hand-washing their mask themselves. This could explain the poor performance of two layered cloth masks, if the self-washing was inadequate. Cloth masks washed in the hospital laundry were as protective as medical masks. Both cloth and medical masks were contaminated, but only cloth masks were reused in the study, reiterating the importance of daily washing of reusable cloth masks using proper method. A well-washed cloth mask can be as protective as a medical mask.Trial resgistration numberACTRN12610000887077.

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A secondary analysis of a randomised controlled trial to investigate the effect of Tai Chi on the instrumented timed up and go test in people with mild to moderate dementia

Aging Clinical and Experimental Research ◽

10.1007/s40520-020-01741-7 ◽

2020 ◽

Author(s):

Jonathan Williams ◽

Samuel Nyman

Keyword(s):

Randomised Controlled Trial ◽

Tai Chi ◽

Training Stimulus ◽

Controlled Trial ◽

Secondary Analysis ◽

Community Dwelling ◽

Timed Up And Go ◽

People With Dementia ◽

Significant Difference ◽

Randomised Controlled

Abstract Background Previous research has identified that Tai Chi is effective for reducing risk of falls and improving timed up and go scores. However, our previous research identified no-significant difference in time to complete the timed up and go test following a Tai Chi intervention in people with dementia. Aim To conduct a secondary analysis to extend our understanding of the effect of Tai Chi on the instrumented Timed Up and Go test. Methods This is a secondary analysis of a randomised controlled trial set in the community. People with dementia, recruited from NHS databases, memory clinics, local charities and self-referral across the south of England, received either 20 weeks of Tai Chi plus normal care or normal care. Outcomes were assessed using the instrumented Timed Up and Go test, completed at baseline and after 6 months. Results From 83 people with dementia volunteering for the study, 67 complete datasets were available for analysis. Within-group pairwise comparison across time revealed no-significant gains for any of the instrumented Timed Up and Go variables, and no-significant difference for between-group pairwise comparisons. Discussion This suggests that Tai Chi had no effect on the instrumented Timed Up and Go in people with dementia. This lack of effect may be due to the lack of specificity of the training stimulus to the outcome measure. Conclusion Tai Chi had no effect on any instrumented Timed Up and Go variables, suggesting Tai Chi may not be best placed to enhance the sub-elements of the instrumented Timed Up and Go to reduce fall risk among community-dwelling people with dementia. Clinical trial registration number: NCT02864056.

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A Sham-Controlled Trial of Acupuncture as An Adjunct in Migraine Prophylaxis

Acupuncture in Medicine ◽

10.1136/acupmed-2013-010362 ◽

2014 ◽

Vol 32 (1) ◽

pp. 12-16 ◽

Cited By ~ 14

Author(s):

Mohsen Foroughipour ◽

Amir Reza Golchian ◽

Mohsen Kalhor ◽

Saeed Akhlaghi ◽

Mohammad Taghi Farzadfard ◽

...

Keyword(s):

Controlled Trial ◽

Sham Acupuncture ◽

Migraine Prophylaxis ◽

Acupuncture Group ◽

Migraine Headaches ◽

Prophylactic Drugs ◽

Significant Difference ◽

Group A ◽

The Difference ◽

Sham Acupuncture Group

Background Migraine is one of the most common types of headache, with significant socioeconomic effects. Prophylactic drugs are used to prevent migraine headaches but are unpromising. Objective To assess the effects of adding acupuncture to conventional migraine prophylaxis. Methods One hundred patients with migraine (41 male, 59 female), in whom prophylactic drugs had not produced a fall of at least 50% in the number of attacks, entered the study. The patients were randomised into two groups, sham and true acupuncture. The patients in both groups continued their prophylactic treatment and received 12 sessions of either true or sham acupuncture. Each session was 30 min and was repeated three times a week. The number of headaches in the two groups was compared at baseline, and at the end of four successive months. Results There was no significant difference in the frequency of attacks between the two groups before intervention. After 1 month, the frequency of attacks each month decreased from 5.1 (0.8) to 3.4 (1.2) in the true acupuncture group, and from 5.0 (0.8) to 4.4 (1.1) in the sham acupuncture group (a significant difference, p<0.001). The frequency continued to decrease in month 2 but increased in months 3 and 4; however, it was still significantly lower than baseline, and the difference remained significant after month 4. Conclusions Acupuncture is applicable as an adjunct to prophylactic drugs in migraineurs in whom the number of attacks does not fall with prophylactic medication.

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Trigger Point Dry Needling versus Strain–counterstrain Technique for Upper Trapezius Myofascial Trigger Points: A Randomised Controlled Trial

Acupuncture in Medicine ◽

10.1136/acupmed-2015-010868 ◽

2016 ◽

Vol 34 (3) ◽

pp. 171-177 ◽

Cited By ~ 14

Author(s):

E Segura-Ortí ◽

S Prades-Vergara ◽

L Manzaneda-Piña ◽

R Valero-Martínez ◽

JA Polo-Traverso

Keyword(s):

Randomised Controlled Trial ◽

Trigger Point ◽

Controlled Trial ◽

Trigger Points ◽

Dry Needling ◽

Significant Group ◽

Myofascial Trigger Points ◽

Upper Trapezius ◽

Pain Pressure Threshold ◽

Randomised Controlled

Background Treatment of active myofascial trigger points includes both invasive and non-invasive techniques. Objectives To compare the effects of upper trapezius trigger point dry needling (DN) and strain–counterstrain (SCS) techniques versus sham SCS. Study Design Randomised controlled trial. Method 34 study subjects with active trigger points were randomly assigned to one of three treatment groups, and received either three sessions of DN (n=12), six sessions of SCS (n=10), or sham SCS (n=12) over a 3-week period. Subjective pain response and subjects’ own ratings of perceived disability were measured. Results The analysis of variance mixed model showed a significant time effect for pain (p<0.001), elicited pain (p<0.001), pain pressure threshold (p<0.01), and neck disability index (p=0.016). Pain at rest decreased in all groups, as follows: DN 18.5 mm (95% CI 4.3 to 32.7 mm); SCS 28.3 mm (95% CI 12.4 to 44.1 mm); sham SCS 21.9 mm (95% CI 3.5 to 40.1 mm). Reductions in disability score (points) were significant in the SCS group (5.5, 95% CI 1.6 to 9.4) but not in the DN (1.4, 95% CI −4.9 to 2.1) or sham SCS (1.8, 95% CI −6.4 to 2.7) groups. There was no significant group×time interaction effect for any variables studied. Conclusions There were no differences between the sham SCS, SCS, and DN groups in any of the outcome measures. DN relieved pain after fewer sessions than SCS and sham SCS, and thus may be a more efficient technique. Future studies should include a larger sample size. Trial Registration Number NCT01290653.

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