Acupuncture for Relief of Gag Reflex in Patients Undergoing Transoesophageal Echocardiography—A Protocol for a Randomized Placebo-Controlled Trial

Background: Gagging during transesophageal echocardiography examination (TEE) can be distressing and even dangerous for patients. The needling of acupuncture point CV24 was described to be effective in reducing the gag reflex during TEE in patients with ischemic stroke or transient ischemic attack. Methods: We describe a proposal for a prospective, randomized, patient, practitioner and assessor-blinded, single-center trial with two arms/groups; real acupuncture will be compared to placebo acupuncture. A total of 60 (30 per group) patients scheduled for elective TEE in order to exclude a cardiac embolic source, endocarditis or for valve failure evaluation will be recruited according to patients’ selection criteria and receive either indwelling fixed intradermal needles at acupoints CV24 and bilateral PC6 or placebo needles at the same areas. Patients, the practitioners who will perform the TEE procedure, and the assessor of the outcome measures will be unaware of the group’s (real or placebo) allocation. Results: The primary outcome is the intensity of gagging, measured using verbal rating scale (VRS-11) from 0 = no gagging to 10 = intolerable gagging. Secondary outcomes include the incidence of gagging, the use of rescue medication, patients’ satisfaction with relief of unwanted side effects during TEE procedure, success of patients’ blinding (patients’ opinion to group allocation), heart rate and oxygen saturation measured by pulse oxymetry. Conclusions: To study the effects of acupuncture against gagging during TEE, we test the needling of acupoints CV24 and PC6 bilaterally. A placebo acupuncture is used for the control group. Trial registration number: NCT NCT0382142.

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Acupuncture for relief of gag reflex in patients undergoing transesophageal echocardiography – a protocol for a randomized sham-controlled trial

10.21203/rs.2.14231/v1 ◽

2019 ◽

Author(s):

Taras Usichenko ◽

Irina Mueller-Kozarez ◽

Stephan Knigge ◽

Klaus Hahnenkamp ◽

Raila Busch ◽

...

Keyword(s):

Transesophageal Echocardiography ◽

Rating Scale ◽

Controlled Trial ◽

Acupuncture Point ◽

Sham Acupuncture ◽

Control Group ◽

Placebo Acupuncture ◽

Real Acupuncture ◽

Gag Reflex ◽

Failure Evaluation

Abstract Background Gagging during transesophageal echocardiography examination (TEE) can be both distressing and even dangerous for patients. Needling of acupuncture point CV24 was described to be effective in reducing of gag reflex during TEE in patients with ischemic stroke or transient ischemic attack.Methods/Design We describe a proposal for a prospective randomized, patient, practitioner and assessor-blinded, single-center trial with two arms/groups: real acupuncture will be compared to placebo acupuncture. A total of 60 (30 per group) patients scheduled for elective TEE in order to exclude a cardiac embolic source, endocarditis or for valve failure evaluation will be recruited according to patients’ selection criteria and receive either indwelling fixed intradermal needles at acupoints CV24 and bilateral PC6 or sham acupuncture at the same sites. Patients undergoing TEE, practitioners performing TEE, and the outcome assessors will be unaware of group (real or placebo) allocation. The primary outcome is the intensity of gagging, measured using verbal rating scale (VRS-11) from 0 = no gagging to 10 = intolerable gagging. Secondary outcomes include the incidence of gagging, the use of rescue medication, patients’ satisfaction with relief of unwanted side effects during the TEE procedure, success of patients’ blinding (patients’ opinion to group allocation), heart rate and oxygen saturation measured by pulse oxymetry.Discussion To study the effects of acupuncture to reduce gagging during TEE we test needling of the acupoints CV24 and PC6 bilaterally. Placebo acupuncture is used for the control group.

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Effects of transcutaneous electrical acupuncture point stimulation on peripheral capillary oxygen saturation in elderly patients undergoing colonoscopy with sedation: a prospective randomized controlled trial

Acupuncture in Medicine ◽

10.1177/0964528420960479 ◽

2020 ◽

pp. 096452842096047

Author(s):

Yongming Chen ◽

Yin Gong ◽

Xiaorong Huai ◽

Xiyao Gu ◽

Diansan Su ◽

...

Keyword(s):

Treatment Group ◽

Elderly Patients ◽

Oxygen Saturation ◽

Controlled Trial ◽

Acupuncture Point ◽

Control Group ◽

Prospective Randomized Controlled Trial ◽

Electrical Acupuncture ◽

Registration Number ◽

Blood Pressures

Introduction: This study investigated whether transcutaneous electrical acupuncture point stimulation (TEAS) at PC6 can reduce the proportion of elderly patients experiencing a drop of ⩾4% in peripheral capillary oxygen saturation (SpO2) while undergoing colonoscopy under sedation. Methods: A total of 32 elderly patients (aged ⩾ 65 years) scheduled for colonoscopy were randomly assigned in a 1:1 ratio to receive either real or sham TEAS (treatment or control groups, respectively). Each patient received oxygen (2 L/min) delivered routinely via nasal cannula. The treatment group was given TEAS at PC6 for 20 min at 2 Hz frequency and 6 mA intensity; the control group underwent the same procedures but with zero frequency/intensity. SpO2 and other physiological parameters were measured prior to sedation and colonoscopy (baseline) and at seven other timepoints through departure from recovery. Depth of anesthesia was measured using a Narcotrend monitor. Results: Significantly fewer patients in the treatment group experienced a ⩾4% decrease from baseline SpO2 (2/16) than patients in the control group (10/16; p = 0.004). The two groups were comparable with regard to respiratory rate, systolic and diastolic blood pressures, mean arterial pressure, and heart rate. Conclusion: TEAS applied at PC6 with 2 Hz frequency was feasible and may be helpful in reducing the rate of hypoxia in elderly patients during colonoscopy. Trial registration number: NCT03775122 (ClinicalTrials.gov).

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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 ◽

10.1136/bmjopen-2019-034003 ◽

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

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Efficacy of pediatric integrative manual therapy in positional plagiocephaly: a randomized controlled trial

Italian Journal of Pediatrics ◽

10.1186/s13052-021-01079-4 ◽

2021 ◽

Vol 47 (1) ◽

Author(s):

Iñaki Pastor-Pons ◽

María Orosia Lucha-López ◽

Marta Barrau-Lalmolda ◽

Iñaki Rodes-Pastor ◽

Ángel Luis Rodríguez-Fernández ◽

...

Keyword(s):

Manual Therapy ◽

Education Program ◽

Controlled Trial ◽

Asymmetry Index ◽

Trial Registration ◽

Control Group ◽

Parental Perception ◽

Positional Plagiocephaly ◽

Caregiver Education ◽

Registration Number

Abstract Background Positional plagiocephaly frequently affects healthy babies. It is hypothesized that manual therapy tailored to pediatrics is more effective in improving plagiocephalic cranial asymmetry than just repositioning and sensory and motor stimulation. Methods Thirty-four neurologically healthy subjects aged less than 28 weeks old with a difference of at least 5 mm between cranial diagonal diameters were randomly distributed into 2 groups. For 10 weeks, the pediatric integrative manual therapy (PIMT) group received manual therapy plus a caregiver education program, while the controls received the same education program exclusively. Cranial shape was evaluated using anthropometry; cranial index (CI) and cranial vault asymmetry index (CVAI) were calculated. Parental perception of change was assessed using a visual analogue scale (− 10 cm to + 10 cm). Results CVAI presented a greater decrease in PIMT group: 3.72 ± 1.40% compared with 0.34 ± 1.72% in the control group (p = 0.000). CI did not present significant differences between groups. Manual therapy led to a more positive parental perception of cranial changes (manual therapy: 6.66 ± 2.07 cm; control: 4.25 ± 2.31 cm; p = 0.004). Conclusion Manual therapy plus a caregiver education program improved CVAI and led to parental satisfaction more effectively than solely a caregiver education program. Trial registration Trial registration number: NCT03659032; registration date: September 1, 2018. Retrospectively registered.

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Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽

10.1177/0333102421989232 ◽

2021 ◽

Vol 41 (3) ◽

pp. 294-304 ◽

Cited By ~ 2

Author(s):

Messoud Ashina ◽

Uwe Reuter ◽

Timothy Smith ◽

Judith Krikke-Workel ◽

Suzanne R Klise ◽

...

Keyword(s):

Controlled Trial ◽

Study Drug ◽

Statistical Testing ◽

Control Group ◽

Double Blind ◽

Treatment Groups ◽

Primary Endpoints ◽

Registration Number ◽

Secondary Endpoints ◽

Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

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

Journal of EMDR Practice and Research ◽

10.1891/emdr-d-20-00036 ◽

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.

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

Journal of Clinical Medicine ◽

10.3390/jcm9072079 ◽

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.

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Analgesic effects of intravenous flunixin and intrafunicular lidocaine or their combination for castration of lambs

Veterinary Record Open ◽

10.1136/vetreco-2017-000266 ◽

2018 ◽

Vol 5 (1) ◽

pp. e000266 ◽

Cited By ~ 2

Author(s):

Paola Straticò ◽

Vincenzo Varasano ◽

Riccardo Suriano ◽

Massimo Mariscoli ◽

Domenico Robbe ◽

...

Keyword(s):

General Anaesthesia ◽

Controlled Trial ◽

Serum Cortisol ◽

Cortisol Concentration ◽

University Teaching ◽

Control Group ◽

Lidocaine Group ◽

Analgesic Effects ◽

Registration Number ◽

Randomised Controlled

ObjectiveTo analyse the effectiveness of intrafunicular lidocaine and intravenous flunixin for reducing pain and signs of stress in lambs undergoing surgical castration.DesignRandomised controlled trial.SettingOne university teaching hospital in Italy.Participants30 healthy male lambs, 9–12 weeks old.InterventionAllocation to five groups: a control group (C), undergoing general anaesthesia but not castration; a surgery group (S), undergoing orchiectomy without analgesic treatment; a surgery-lidocaine group (SL), undergoing orchiectomy and receiving intrafunicular 2 per cent lidocaine solution; a surgery-flunixin group (SF), undergoing orchiectomy and receiving intravenous flunixin; a surgery-flunixin-lidocaine group (SFL), undergoing orchiectomy and receiving both intrafunicular lidocaine and intravenous flunixin.Main outcome measuresNociception and stress were assessed through intraoperative indicators, serum cortisol concentration, glycaemia, behaviour, immune response and clinical evaluation of the heart rate (HR), respiratory rate and rectal temperature after surgery.ResultsGroups S and SL showed increased values of intraoperative HR, mean arterial pressure and postoperative cortisol concentration. In group SFL, cortisol values were similar to those of group C. No other difference could be detected.ConclusionsThe combination of intravenous flunixin and intrafunicular lidocaine reduced the pain and discomfort of lambs castrated under general anaesthesia. Intrafunicular lidocaine alone did not prevent pain or discomfort associated with castration.Trial registration number30/2012/CEISA/COM.

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Effect of Low-Dose (Single-Dose) Magnesium Sulfate on Postoperative Analgesia in Hysterectomy Patients Receiving Balanced General Anesthesia

Anesthesiology Research and Practice ◽

10.1155/2015/306145 ◽

2015 ◽

Vol 2015 ◽

pp. 1-6 ◽

Cited By ~ 4

Author(s):

Arman Taheri ◽

Katayoun Haryalchi ◽

Mandana Mansour Ghanaie ◽

Neda Habibi Arejan

Keyword(s):

Single Dose ◽

Postoperative Pain ◽

General Anesthesia ◽

Magnesium Sulfate ◽

Pain Score ◽

Normal Saline ◽

Low Dose ◽

Rating Scale ◽

Controlled Trial ◽

Control Group

Background and Aim. Aparallel, randomized, double blinded, placebo-controlled trial study was designed to assess the efficacy of single low dose of intravenous magnesium sulfate on post-total abdominal hysterectomy (TAH) pain relief under balanced general anesthesia.Subject and Methods. Forty women undergoing TAH surgery were assigned to two magnesium sulfate (N=20) and normal saline (N=20) groups randomly. The magnesium group received magnesium sulfate 50 mg·kg−1in 100 mL of normal saline solution i.v as single-dose, just 15 minutes before induction of anesthesia whereas patients in control group received 100 mL of 0.9% sodium chloride solution at the same time. The same balanced general anesthesia was induced for two groups. Pethidine consumption was recorded over 24 hours precisely as postoperative analgesic. Pain score was evaluated with Numeric Rating Scale (NRS) at 0, 6, 12, and 24 hours after the surgeries.Results. Postoperative pain score was lower in magnesium group at 6, 12, and 24 hours after the operations significantly (P<0.05).Pethidinerequirement was significantly lower in magnesium group throughout 24 hours after the surgeries (P=0.0001).Conclusion. Single dose of magnesium sulfate during balanced general anesthesia could be considered as effective and safe method to reduce postoperative pain and opioid consumption after TAH.

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“Short- and mid-term effects of adding upper cervical manual therapy to a conventional physical therapy program in patients with chronic mechanical neck pain. Randomized controlled clinical trial.”

Clinical Rehabilitation ◽

10.1177/0269215520965054 ◽

2020 ◽

pp. 026921552096505

Author(s):

Vanessa González-Rueda ◽

Carlos López-de-Celis ◽

Elena Bueno-Gracia ◽

Jacobo Rodríguez-Sanz ◽

Albert Pérez-Bellmunt ◽

...

Keyword(s):

Neck Pain ◽

Rating Scale ◽

Controlled Trial ◽

Neck Disability Index ◽

Chronic Neck Pain ◽

Control Group ◽

Controlled Clinical Trial ◽

Primary Care Center ◽

Randomized Controlled ◽

Upper Cervical

Objective: To evaluate the effect of adding an Upper Cervical Translatoric Mobilization (UCTM) or an Inhibitory Suboccipital Technique (IST) to a physiotherapy treatment in the symptomatology and function of mechanical chronic neck pain patients. Design: Randomized controlled trial. Setting: Primary Care Center in Cornellà, Spain. Subjects: 78 patients (64 women), with mean age (SD) of 59.96 (13.30) years with mechanical chronic neck pain were divided in three groups: control, IST and UCTM groups. Interventions: All groups received 15 physiotherapy sessions for three weeks. The UCTM and IST groups added 5 minutes of the assigned technique during six sessions. Main measures: Neck disability index (NDI) and numeric pain rating scale (NPRS) for neck pain were measured baseline, three-weeks and 15-weeks follow-up. Results: NDI (SD) at baseline, three-weeks and 15-weeks were 11.62 (7.08), 9.65 (6.25), 7.58 (5.64) for the control group, 14.38 (6.92), 8.50 (6.11), 7.12 (4.98) for the IST group and 13.19(7.23), 5.35(6.10), 4.35(2.76) for the UCTM group. NPRS (SD) at baseline, three-weeks and 15-weeks were 58.69 (19.46), 45.19 (23.43), 44.58 (24.08) for the control group; 64.08 (19.26), 42.19 (19.69), 34 (21.14) for the IST group; and 67.65 (20.65), 36.23 (20.10), 39.85 (25.44) for the UCTM group. Conclusions: Compared with no treatment, both forms of mobilization were associated with reduced disability at three weeks, and UCTM remained better than control at 15 weeks; there were no significant differences between the two mobilization groups. Trial registration: This study was registered in Clinicaltrials.gov (NCT02832232).

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