scholarly journals A Sham-Controlled Study of Neurofeedback for Pain Management

2021 ◽  
Vol 15 ◽  
Author(s):  
Charlotte Ide-Walters ◽  
Trevor Thompson
Keyword(s):  
Pain Management ◽  
Rating Scale ◽  
Controlled Trial ◽  
Experimental Pain ◽  
Controlled Study ◽  
Control Group ◽  
Management Technique ◽  
Therapeutic Effects ◽  
Electrophysiological Activity ◽  
Healthy Participants

BackgroundNeurofeedback (NFB) attempts to alter the brain’s electrophysiological activity and has shown potential as a pain management technique. Existing studies, however, often lack appropriate control groups or fail to assess whether electrophysiological activity has been successfully regulated. The current study is a randomized controlled trial comparing changes in brain activity and pain during NFB with those of a sham-control group.MethodsAn experimental pain paradigm in healthy participants was used to provide optimal control of pain sensation. Twenty four healthy participants were blind randomized to receive either 10 × NFB (with real EEG feedback) or 10 × sham (with false EEG feedback) sessions during noxious cold stimulation. Prior to actual NFB training, training protocols were individually determined for each participant based on a comparison of an initial 32-channel qEEG assessment administered at both baseline and during an experimental pain task. Each individual protocol was based on the electrode site and frequency band that showed the greatest change in amplitude during pain, with alpha or theta up-regulation at various electrode sites (especially Pz) the most common protocols chosen. During the NFB sessions themselves, pain was assessed at multiple times during each session on a 0–10 rating scale, and ANOVA was used to examine changes in pain ratings and EEG amplitude both across and during sessions for both NFB and sham groups.ResultsFor pain, ANOVA trend analysis found a significant general linear decrease in pain across the 10 sessions (p = 0.015). However, no significant main or interaction effects of group were observed suggesting decreases in pain occurred independently of NFB. For EEG, there was a significant During Session X Group interaction (p = 0.004), which indicated that EEG amplitude at the training site was significantly closer to the target amplitude for the NFB compared to the sham group during painful stimulation, but this was only the case at the beginning of the cold task.ConclusionWhile these results must be interpreted within the context of an experimental pain model, they underline the importance of including an appropriate comparison group to avoid attributing naturally occurring changes to therapeutic effects.

Do we need a confederate in full-scale medical simulation? A randomized controlled trial.

2021 ◽  
Author(s):  
Jeremie Traoré ◽  
Frédéric Balen ◽  
Thomas Geeraerts ◽  
Sandrine Charpentier ◽  
Xavier Dubucs ◽  
...  
Keyword(s):  
Emergency Medicine ◽  
Rating Scale ◽  
Controlled Trial ◽  
Full Scale ◽  
Global Rating Scale ◽  
Controlled Study ◽  
Control Group ◽  
Global Rating ◽  
Performance Score ◽  
Overall Performance

Abstract Background: During simulation training, the confederate is a member of the pedagogical team. Its role is to facilitate the interaction between participants and the environment, and is thought to increase realism and immersion. Its influence on participants' performance in full-scale simulation remains however unknown. The purpose of this study was to explore the effect of the presence of a confederate on the participants’ performance during full-scale simulation of crisis medical situations. Methods: This was a prospective, randomized study comparing 2 parallel groups. Participants were emergency medicine residents engaging in a simulation session, with or without confederates. Participants were then evaluated on their Crisis Resource Management performance (CRM). The overall performance score on the Ottawa Global Rating Scale was assessed as primary outcome and the 5 non-technical CRM skills as secondary outcomes.Results: A total of 63 simulation sessions, including 63 residents, were included for statistical analysis (n= 32 for Control group and 31 for Confederate group). The mean Overall Performance score was 3.9± 0.8 in the Control group and 4.0± 1.1 in the Confederate group, 95% confidence interval of the difference [-0.6; 0.4], p=0.60. No significant differences between the two groups were observed on each CRM items (leadership, situational awareness, communication, problem solving, resource utilization)Conclusion: In this randomized and controlled study, the presence of confederates during full-scale simulated practice of crisis medical situations does not seem to improve the CRM skills performance of Emergency medicine residents. Trial registration: this study does not need to be registered on Clintrial as it doesn’t report a health care intervention on human participants.

scholarly journals Ultrasound-guided superficial cervical plexus block for analgesia in patients undergoing craniotomy via suboccipital retrosigmoid approach: study protocol of a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034003
Author(s):  
Kun Peng ◽  
Min Zeng ◽  
Jia Dong ◽  
Xiang Yan ◽  
Dexiang Wang ◽  
...  
Keyword(s):  
Nerve Block ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
Cervical Plexus ◽  
Ethics Review ◽  
Superficial Cervical Plexus Block ◽  
Cervical Plexus Block ◽  
Plexus Block

IntroductionScalp nerve block has been proven to be an alternative choice to opioids in multimodal analgesia. However, for the infratentorial space-occupying craniotomy, especially the suboccipital retrosigmoid craniotomy, scalp nerve block is insufficient.Methods and analysisThe study is a prospective, single-centre, randomised, paralleled-group controlled trial. Patients scheduled to receive elective suboccipital retrosigmoid craniotomy will be randomly assigned to the superficial cervical plexus block group or the control group. After anaesthesia induction, superficial cervical plexus nerve block will be performed under the guidance of ultrasound. The primary outcome is the cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump within 24 hours after surgery. Secondary outcomes include the cumulative consumption of sufentanil at other four time points and numerical rating scale pain severity score.Ethics and disseminationThe protocol (version number: 2.0, 10 April 2019) has been approved by the Ethics Review Committee of China Registered Clinical Trials (Ethics Review No. ChiECRCT-20190047). The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberNCT04036812

scholarly journals Efficacy of axial TheraTogs on gait pattern in children with dyskinetic cerebral palsy: a randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Shamekh Mohamed El-Shamy ◽  
Ehab Mohamed Abd El Kafy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Muscle Tone ◽  
Controlled Trial ◽  
Gait Pattern ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

scholarly journals Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial

ISRN Nursing ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Paul Ratanasiripong ◽  
Nop Ratanasiripong ◽  
Duangrat Kathalae
Keyword(s):  
Nursing Students ◽  
Stress Level ◽  
Clinical Training ◽  
Intervention Program ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Moderate Increase ◽  
Randomized Controlled ◽  
The Impact

Purpose. It has been well documented that nursing students across the world experience stress and anxiety throughout their education and training. The purpose of this randomized controlled study is to investigate the impact of biofeedback intervention program on nursing students' levels of stress and anxiety during their first clinical training. Methods. Participants consisted of 60 second-year baccalaureate nursing students. The 30 participants in the biofeedback group received training on how to use the biofeedback device to assist in stress and anxiety management for 5 weeks while the 30 in the control group did not receive any training. Findings. Results indicated that the biofeedback group was able to maintain the stress level while the control group had a significant increase in the stress level over the 5-week period of clinical training. Additionally, the biofeedback group had a significant reduction in anxiety, while the control group had a moderate increase in anxiety. Conclusions. The better the nursing students can manage their stress and anxiety, the more successful they can be in their clinical training. Ultimately, the more psychologically healthy the nursing students are, the more likely they will flourish and graduate to become productive and contributing members of the nursing profession.

scholarly journals Foam Rolling Elicits Neuronal Relaxation Patterns Distinct from Manual Massage: A Randomized Controlled Trial

2021 ◽  
Vol 11 (6) ◽  
pp. 818
Author(s):  
Yann Kerautret ◽  
Aymeric Guillot ◽  
Sébastien Daligault ◽  
Franck Di Rienzo
Keyword(s):  
Skin Conductance ◽  
Muscle Pain ◽  
Controlled Trial ◽  
Muscle Relaxation ◽  
Well Being ◽  
Self Report ◽  
Controlled Study ◽  
Control Group ◽  
Foam Rolling ◽  
Randomized Controlled

The present double-blinded, randomized controlled study sought to compare the effects of a full-body manual massage (MM) and a foam rolling (FR) intervention on subjective and objective indexes of performance and well-being. A total of 65 healthy individuals were randomly allocated to an FR, MM, or a control group who received a cognitively oriented relaxation routine. Self-report ratings of perceived anxiety, muscle relaxation, and muscle pain were used to index changes in affect and physical sensations. The sit-and-reach and toe-touch tests, as well as a mental calculation task, were used to index motor and cognitive performances, respectively. We also conducted resting-state electroencephalography and continuous skin conductance recordings before and after the experimental intervention. Both FR and MM groups exhibited neural synchronization of alpha and beta oscillations during the posttest. Skin conductance increased from the pretest to the posttest in the relaxation group, but decreased in the FR group. All interventions improved range of motion, although only the MM group outperformed the relaxation group for the toe-touch performance. MM was associated with reduced muscle pain and increased muscle relaxation. Reduced perceived anxiety after the intervention was observed in the FR group only. Overall, MM and FR both improved objective and subjective indexes of performance and well-being. Differences between the two massage interventions are discussed in relation to the effects of pressure stimulation on autonomic regulations and the proactive vs. retroactive nature of FR, compared to MM.

Efficacy of EMDR Therapy on the Pain Intensity and Subjective Distress of Cancer Patients

2021 ◽  
Vol 15 (1) ◽  
pp. 18-28
Author(s):  
Naeem Abdi ◽  
Mohammad Malekzadeh ◽  
Zhila Fereidouni ◽  
Mohammad Behnammoghadam ◽  
Parisa Zaj ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Rating Scale ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Sampling Technique ◽  
Control Group ◽  
Subjective Distress ◽  
Patients With Cancer ◽  
Before And After ◽  
Emdr Therapy

The present study was carried out to investigate the efficacy of eye movement desensitization and reprocessing (EMDR) therapy in treating pain and subjective distress of patients with cancer. A randomized controlled trial was performed on patients with cancer suffering from moderate to severe cancer pain in Yasuj, Iran, in 2019 and 2020. Sixty patients aged 30–60 years who fulfilled the inclusion criteria were selected using a consensus sampling technique. Patients were randomly assigned to EMDR therapy or control groups based on random block allocation. EMDR therapy was administered in six to eight daily 1-hour sessions. The control group received the standard treatment provided by the hospital. A Numeric Pain-Rating Scale (NRS) and the Subjective Units of Disturbance Scale (SUDS) were used to assess pain and subjective distress before and after the intervention in each session. The collected data were analyzed by descriptive statistics, chi-square test, and independent t test using Statistical Package for the Social Sciences (SPSS) version 24. The mean pain intensity and subjective distress score in the experimental group before and after the EMDR intervention were significantly reduced (p < .001). In the control group, no decreases in NRS and SUDS scores occurred at any time (p > .05). Differences in pain scores between the groups were statistically significant (p < .001). EMDR can effectively and sustainably reduce the pain and subjective distress experienced by patients with cancer. Thus, EMDR is a recommended therapeutic option to mitigate pain and subjective distress among patients with cancer.

scholarly journals Intensive Motion Style Acupuncture Treatment (MSAT) Is Effective for Patients with Acute Whiplash Injury: A Randomized Controlled Trial

2020 ◽  
Vol 9 (7) ◽  
pp. 2079
Author(s):  
Doori Kim ◽  
Kyoung-Sun Park ◽  
Jin-Ho Lee ◽  
Won-Hyung Ryu ◽  
Heeyoung Moon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Whiplash Injury ◽  
Rating Scale ◽  
Acupuncture Treatment ◽  
Controlled Trial ◽  
Rank Test ◽  
Control Group ◽  
Korean Medicine ◽  
Randomized Controlled ◽  
Motion Style

In this single-center, parallel, randomized controlled trial, we aim to examine the effects and safety of motion style acupuncture treatment (MSAT; a combination of acupuncture and Doin therapy) on pain reduction and functional improvement in patients with whiplash-associated disorders (WADs). Ninety-seven patients with cervical pain admitted to the Bucheon Jaseng Hospital of Korean Medicine, South Korea, due to acute whiplash injury were treated with integrative Korean medicine (IKM) with (MSAT group, 48 patients) or without (control group, 49 patients) an additional 3-day MSAT during hospitalization (5–14 days) and followed-up for 90 days. The mean numeric rating scale (NRS) scores of the MSAT and control groups at baseline were 5.67 (95% confidence interval (CI), 5.33, 6.01) and 5.44 (95% CI, 5.06, 5.82), respectively, and on day 5, 3.55 (95% CI, 3.04, 4.06) and 4.59 (95% CI, 4.10–5.07), respectively. The NRS change difference between the groups was −1.07 (95% CI, −1.76, −0.37). The rate of recovery of neck pain (NRS score change ≥ 2 points) was significantly faster in the MSAT than in the control group (log-rank test p = 0.0055). IKM treatment combined with MSAT may be effective in reducing the pain and improving the range of motion in patients with WADs.

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.

Acupuncture for Low Back Pain in Pregnancy – a Prospective, Quasi- Randomised, Controlled Study

2004 ◽  
Vol 22 (2) ◽  
pp. 60-67 ◽  
Author(s):  
João Bosco Guerreiro da Silva ◽  
Mary Uchiyama Nakamura ◽  
José Antonio Cordeiro ◽  
Luiz Kulay
Keyword(s):  
Pelvic Pain ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Real Life ◽  
Acupuncture Group ◽  
Controlled Study ◽  
Control Group ◽  
Study Group ◽  
Low Back ◽  
Average Pain

This study was undertaken to investigate the effects of acupuncture in low back and pelvic pain during pregnancy under real life conditions, as compared with patients undergoing conventional treatment alone. A total of 61 conventionally treated pregnant women were allocated randomly into two groups to be treated or not by acupuncture. Twenty-seven patients formed the study group and 34 the control group. They reported the severity of pain using a Numerical Rating Scale from 0 to 10, and their capacity to perform general activities, to work, and to walk. We also assessed the use of analgesic drugs. Women were followed up for eight weeks and interviewed five times, at two-week intervals. All women completed the study. In the study group the average pain during the study period showed a larger reduction (4.8 points) than the control group (−0.3 points) (P<0.0001). Average pain scores decreased by at least 50% over time in 21 (78%) patients in the acupuncture group and in five (15%) patients in the control group (P<0.0001). Maximum pain and pain at the moment of interview were also less in the acupuncture group compared with the control group. The capacity to perform general activities, to work and to walk was improved significantly more in the study group than in the control group (P<0.05). The use of paracetamol was lower in the acupuncture group (P<0.01). These results indicate that acupuncture seems to alleviate low back and pelvic pain during pregnancy, as well as to increase the capacity for some physical activities and to diminish the need for drugs, which is a great advantage during this period.

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).

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