Comparison of electroacupuncture and manual acupuncture for patients with plantar heel pain syndrome: a randomized controlled trial

2020 ◽  
pp. 096452842094773
Author(s):  
Weiming Wang ◽  
Yan Liu ◽  
Ruimin Jiao ◽  
Sixing Liu ◽  
Jie Zhao ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Heel Pain ◽  
Manual Acupuncture ◽  
Clinical Trial Registry ◽  
Intention To Treat ◽  
Plantar Heel Pain

Background: Plantar heel pain syndrome (PHPS), also known as plantar fasciitis, affects millions of people worldwide. Electroacupuncture (EA) and manual acupuncture (MA) are the two acupuncture modalities frequently used for PHPS in the clinical setting. However, which modality is more effective has yet to be determined. Objective: To examine whether EA is more effective than MA with regards to pain relief for patients with PHPS. Methods: Participants were randomly assigned (1:1) to receive 12 treatment sessions of EA or MA over 4 weeks with 24 weeks of follow-up. The primary outcome was the proportion of treatment responders, defined as patients with at least a 50% reduction from baseline in the worst pain intensity experienced during the first steps in the morning after a 4-week treatment, measured using a visual analogue scale (VAS, 0–100; higher scores signify worse pain). Analysis was by intention-to-treat. Results: Ninety-two patients with a clinical diagnosis of PHPS were enrolled from 29 July 2018 through 28 June 2019. Of the patients, 78 (85%) completed the treatment and follow-up. The primary outcome occurred in 54.8% (23/42) of the EA group compared to 50.0% (21/42) of the MA group after the 4-week treatment (difference –4.76, 95% confidence interval, –26.10 to 16.57, P = 0.662). There were no significant between-group differences for any secondary outcomes after 4 weeks of treatment and at 16 weeks and 28 weeks of follow-up. There were no serious treatment-related adverse events in either group. Conclusion: Among patients with PHPS, EA did not have a better effect with respect to relieving pain intensity than MA at week 4, although both EA and MA appeared to have positive temporal effects, with decreased heel pain and improved plantar function. Trial registration number: ChiCTR1800016531 (Chinese Clinical Trial Registry).

scholarly journals Electroacupuncture versus manual acupuncture in the treatment of plantar heel pain syndrome: study protocol for an upcoming randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e026147 ◽  
Author(s):  
Weiming Wang ◽  
Yan Liu ◽  
Jie Zhao ◽  
Ruimin Jiao ◽  
Zhishun Liu
Keyword(s):  
Pain Intensity ◽  
Controlled Trial ◽  
Pressure Pain Threshold ◽  
Safety Evaluation ◽  
Pain Syndrome ◽  
Heel Pain ◽  
Manual Acupuncture ◽  
Global Improvement ◽  
Plantar Heel Pain ◽  
Change In Mean

IntroductionPlantar heel pain syndrome(PHPS) is a common cause of heel pain. It may worsen a patient’s quality of life, and potentially lead to knee, hip or lower back problems. Previous studies have shown that electroacupuncture (EA) and manual acupuncture (MA) are effective treatments for relieving pain in patients with PHPS. However, little evidence supports the use of one intervention over the other.Methods and analysisA total of 92 patients diagnosed with PHPS will be recruited and randomly assigned to an EA group or an MA group at a ratio of 1:1. Patients in both groups will receive a 30 min acupuncture treatment (three times per week) for a total of 12 sessions over 4 weeks. The primary outcome will be the proportion of patients with at least 50% reduction from baseline in the worst pain intensity measured by visual analogue scale (0–100, higher scores signify worse pain) at first steps in the morning after 4-week treatment. The secondary outcomes will include change in worst pain intensity at first steps in the morning, change in mean pain intensity at first steps in the morning, change in worst pain intensity during the day, change in mean pain intensity during the day, change in the pressure pain threshold, change in ankle-dorsiflexion range of motion, change in Foot and Ankle Ability Measure total score and subscale scores, patients’ global improvement assessment, patients’ expectations for acupuncture and safety evaluation. We will perform all statistical analysis following the intention-to-treat principle.Ethics and disseminationThe study has been approved by our ethics review board (Protocol Approval No. 2018–010-KY). The study findings will be disseminated through presentation at a high-impact medical journal, with online access. We also to plan to present it in select conferences and scientific meetings.Trial registrationChiCTR-1800016531; Pre-results.

scholarly journals Additional effect of pain neuroscience education to craniocervical manual therapy and exercises for pain intensity and disability in temporomandibular disorders: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aroldo dos Santos Aguiar ◽  
Cesar Bataglion ◽  
Lilian Ramiro Felício ◽  
Beatriz Azevedo ◽  
Thaís Cristina Chaves
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Intensity ◽  
Manual Therapy ◽  
Temporomandibular Disorders ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Screening Process ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Neuroscience Education

Abstract The objective of this study will be to investigate the additional effect of pain neuroscience education program compared to a craniocervical manual therapy and exercises program for pain intensity and disability in patients with temporomandibular disorders (TMD). This study will be a randomized controlled trial comprising a sample of 148 participants. Subjects between 18 and 55 years, both genders, will undergo a screening process to confirm painful TMD by the Research Diagnostic Criteria (RDC/TMD), and then the volunteers will be randomized into two groups (G1: pain neuroscience education + craniocervical manual therapy and exercises vs. G2: craniocervical manual therapy and exercises). The volunteers will be recruited at the dentistry clinic. The intervention will be administered twice a week for 6 weeks by a single therapist lasting 1 h per session. The primary outcome will be pain intensity and disability and the secondary outcomes will be pain self-efficacy, kinesiophobia, and global perceived effect of improvement. The participants will be assessed immediately after the last session and at one- and three-month follow-ups. All statistical analyses will be conducted following intention-to-treat principles, and the treatment effects will be calculated using linear mixed models. The results of this study may contribute to understand the additional effect of pain neuroscience education intervention on TMD patients submitted to manual therapy and exercise. Trial registration ClinicalTrials.gov NCT03926767. Registered on April 29, 2019.

scholarly journals Diaphragm Used with Replens Gel and Risk of Bacterial Vaginosis: Results from a Randomized Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Craig R. Cohen ◽  
Su-Chun Cheng ◽  
Stephen Shiboski ◽  
Tsungai Chipato ◽  
Martin Matu ◽  
...  
Keyword(s):  
Bacterial Vaginosis ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Vaginal Swab ◽  
Intention To Treat ◽  
Hiv Acquisition ◽  
And Control ◽  
Treat Analysis

Background. Bacterial vaginosis (BV) has been linked to female HIV acquisition and transmission. We investigated the effect of providing a latex diaphragm with Replens and condoms compared to condom only on BV prevalence among participants enrolled in an HIV prevention trial.Methods. We enrolled HIV-seronegative women and obtained a vaginal swab for diagnosis of BV using Nugent’s criteria; women with BV (score 7–10) were compared to those with intermediate (score 4–6) and normal flora (score 0–3). During quarterly follow-up visits over 12–24 months a vaginal Gram stain was obtained. The primary outcome was serial point prevalence of BV during followup.Results. 528 participants were enrolled; 213 (40%) had BV at enrollment. Overall, BV prevalence declined after enrollment in women with BV at baseline (OR=0.4, 95% CI 0.29–.56) but did not differ by intervention group. In the intention-to-treat analysis BV prevalence did not differ between the intervention and control groups for women who had BV (OR=1.01, 95% CI 0.52–1.94) or for those who did not have BV (OR=1.21, 95% CI 0.65–2.27) at enrollment. Only 2.1% of participants were treated for symptomatic BV and few women (5–16%) were reported using anything else but water to cleanse the vagina over the course of the trial.Conclusions. Provision of the diaphragm, Replens, and condoms did not change the risk of BV in comparison to the provision of condoms alone.

scholarly journals Doxycycline Versus Azithromycin for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Julia C Dombrowski ◽  
Michael R Wierzbicki ◽  
Lori M Newman ◽  
Jonathan A Powell ◽  
Ashley Miller ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Care ◽  
Nucleic Acid Amplification ◽  
Absolute Difference ◽  
Complete Case ◽  
Double Blind ◽  
Intention To Treat ◽  
Sex With Men

Abstract Background Azithromycin and doxycycline are both recommended treatments for rectal Chlamydia trachomatis (CT) infection, but observational studies suggest that doxycycline may be more effective. Methods This randomized, double-blind, placebo-controlled trial compared azithromycin (single 1-g dose) versus doxycycline (100 mg twice daily for 7 days) for the treatment of rectal CT in men who have sex with men (MSM) in Seattle and Boston. Participants were enrolled after a diagnosis of rectal CT in clinical care and underwent repeated collection of rectal swabs for nucleic acid amplification testing (NAAT) at study enrollment and 2 weeks and 4 weeks postenrollment. The primary outcome was microbiologic cure (CT-negative NAAT) at 4 weeks. The complete case (CC) population included participants with a CT-positive NAAT at enrollment and a follow-up NAAT result; the intention-to-treat (ITT) population included all randomized participants. Results Among 177 participants enrolled, 135 (76%) met CC population criteria for the 4-week follow-up visit. Thirty-three participants (19%) were excluded because the CT NAAT repeated at enrollment was negative. Microbiologic cure was higher with doxycycline than azithromycin in both the CC population (100% [70 of 70] vs 74% [48 of 65]; absolute difference, 26%; 95% confidence interval [CI], 16–36%; P < .001) and the ITT population (91% [80 of 88] vs 71% [63 of 89]; absolute difference, 20%; 95% CI, 9–31%; P < .001). Conclusions A 1-week course of doxycycline was significantly more effective than a single dose of azithromycin for the treatment of rectal CT in MSM. Clinical Trials Registration ClinicalTrials.gov (NCT03608774).

scholarly journals Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

Chronic Plantar Heel Pain: Treatment with a Short Leg Walking Cast

1996 ◽  
Vol 17 (1) ◽  
pp. 41-42 ◽  
Author(s):  
Christopher L. Tisdel ◽  
Marion C. Harper
Keyword(s):  
Complete Resolution ◽  
Surgical Intervention ◽  
Pain Treatment ◽  
Heel Pain ◽  
Treatment Modalities ◽  
Plantar Heel Pain ◽  
Long Term Follow Up

The efficacy of a short leg walking cast in the treatment of chronic plantar heel pain was assessed for 32 patients with 37 involved extremities treated over a 2-year period. All patients had failed numerous other treatment modalities and had been symptomatic for an average of 1 year. Long-term follow-up for 24 patients with 28 involved extremities revealed complete resolution of pain for 7 extremities (25%), improvement for 17 (61%), and no improvement for 4 (14%). Ten (42%) patients were completely satisfied with cast treatment, 3 (12%) were satisfied with reservations, and 11 (46%) were dissatisfied. Casting appears to be a reasonable option for patients with recalcitrant heel pain and should be offered before surgical intervention.

Diclofenac Sodium Gel in Patients with Primary Hand Osteoarthritis: A Randomized, Double-blind, Placebo-controlled Trial

2009 ◽  
Vol 36 (9) ◽  
pp. 1991-1999 ◽  
Author(s):  
ROY D. ALTMAN ◽  
RENÉE-LILIANE DREISER ◽  
CHESTER L. FISHER ◽  
WALTER F. CHASE ◽  
DONATUS S. DREHER ◽  
...  
Keyword(s):  
Disease Activity ◽  
Pain Intensity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Diclofenac Sodium ◽  
Global Rating ◽  
Hand Osteoarthritis ◽  
Dominant Hand ◽  
Double Blind ◽  
Secondary Outcomes

Objective.To measure the efficacy and safety of diclofenac sodium gel in patients with primary hand osteoarthritis (OA).Methods.In a randomized, double-blind, placebo-controlled trial, men and women aged ≥ 40 years diagnosed with primary OA in the dominant hand were randomly assigned to self-apply topical 1% diclofenac sodium gel (Voltaren® Gel) (n = 198) or vehicle (n = 187) to both hands 4 times daily for 8 weeks. Primary outcome measures included OA pain intensity (100-mm visual analog scale), total Australian/Canadian Osteoarthritis Hand Index (AUSCAN) score, and global rating of disease activity at 4 and 6 weeks. Secondary outcomes included onset of efficacy in Weeks 1 and 2, durability of efficacy at 8 weeks, measures of disease activity in the dominant hand, pain intensity in the non-dominant hand, AUSCAN subindices, end of study rating of efficacy, and Osteoarthritis Research Society International response criteria.Results.Diclofenac sodium gel decreased pain intensity scores by 42%–45%, total AUSCAN scores by 35%–40%, and global rating of disease by 36%–40%. Significant differences favoring diclofenac sodium gel over vehicle were observed at Week 4 for pain intensity and AUSCAN, with a trend for global rating of disease activity. At Week 6, diclofenac sodium gel treatment significantly improved each primary outcome measure compared with vehicle. Secondary outcomes generally supported the primary outcomes. The most common treatment-related adverse event (AE) was application-site paresthesia. Most AE were mild. No cardiac events, gastrointestinal bleeding, or ulcers were reported.Conclusion.Topical diclofenac sodium gel was generally well tolerated and effective in primary hand OA. (NCT ID: NCT00171665)

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

scholarly journals Relative effectiveness of a full versus reduced version of the ‘Smoke Free’ mobile application for smoking cessation: a randomised controlled trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 1524 ◽  
Author(s):  
David Crane ◽  
Harveen Kaur Ubhi ◽  
Jamie Brown ◽  
Robert West
Keyword(s):  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Relative Effectiveness ◽  
Behaviour Change Techniques ◽  
Full Version ◽  
Intention To Treat ◽  
Support Programmes ◽  
Randomised Controlled

Background: Smartphone applications (apps) are popular aids for smoking cessation. Smoke Free is an app that delivers behaviour change techniques used in effective face-to-face behavioural support programmes. The aim of this study was to assess whether the full version of Smoke Free is more effective than the reduced version. Methods:  This was a two-arm randomised controlled trial. Smokers who downloaded Smoke Free were randomly offered the full or reduced version; 28,112 smokers aged 18+ years who set a quit date were included. The full version provided updates on benefits of abstinence, progress (days smoke free), virtual ‘badges’ and daily ‘missions’ with push notifications aimed at preventing and managing cravings. The reduced version did not include the missions. At baseline the app recorded users’: device type (iPhone or Android), age, sex, daily cigarette consumption, time to first cigarette of the day, and educational level. The primary outcome was self-reported complete abstinence from the quit date in a 3-month follow-up questionnaire delivered via the app. Analyses conducted included logistic regressions of outcome on to app version (full versus reduced) with adjustment for baseline variables using both intention-to-treat/missing-equals smoking (MES) and follow-up-only (FUO) analyses. Results: The 3-month follow-up rate was 8.5% (n=1,213) for the intervention and 6.5% (n=901) for the control. A total of 234 participants reported not smoking in the intervention versus 124 in the control, representing 1.6% versus 0.9% in the MES analysis and 19.3% versus 13.8% in the FUO analysis. Adjusted odds ratios were 1.90, 95%CI=1.53-2.37 (p<0.001) and 1.50, 95%CI=1.18-1.91 (p<0.001) in the MES and FUO analyses respectively. Conclusions: Despite very low follow-up rates using in-app follow up, both intention-to-treat/missing equals smoking and follow-up only analyses showed the full version of the Smoke Free app to result in higher self-reported 3-month continuous smoking abstinence rates than the reduced version.

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