• Title/Summary/Keyword: Randomized clinical trial

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Case Report of the Pityriasis Rosea Patient with Pruritus Treated by Korean Medicine Treatment alone (소양감이 동반된 장미색 비강진 환자의 한방단독치료 보고)

  • Lee, Kyoungeun;Kim, Jungpil;Jeong, Seonhyung;Ahn, Joon;Jeong, Hyein;Kim, Kyounghan;Jang, Insoo;Choi, Yoomin;Oh, Yongtaek
    • Herbal Formula Science
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    • v.30 no.1
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    • pp.27-36
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    • 2022
  • Objective : The purpose of this study is to present a case report with the adult patient who needed active treatment of pityriasis rosea with severe pruritus, and did not respond to steroid treatment in the preceding month. Methods : The subject is an adult patient with pityriasis rosea over the age of 40 without any other diseases. We administered Korean medicine treatment with Bangpungtongseong-san (防⾵通聖散) and acupuncture. The effects of the treatment were evaluated via scales including Pruritus score, Pityriasis Rosea Severity Score (PRSS), and picture. Results : After the treatment Pruritus score/PRSS index of the case changed from 8/20 to 0/0. No other severe adverse reactions were reported. No more recurrence or pruritus was confirmed in follow-up. Conclusions : Korean medicine treatment with Bangpungtongseong-san showed marked improvement in pruritus and skin symptoms of pityriasis rosea in need of active care. With the lack of existing clinical reports of pityriasis rosea, we found that Korean medicine treatment could be an effective way, and it is expected that Bangpungtongseong-san could be administered to pityriasis rosea patients. Randomized-controlled trial for further evaluation will be needed in the future.

Anesthetic efficacy of supplemental buccal infiltration versus intraligamentary injection in mandibular first and second molars with irreversible pulpitis: a prospective randomized clinical trial

  • Zargar, Nazanin;Shojaeian, Shiva;Vatankhah, Mohammadreza;Heidaryan, Shirin;Ashraf, Hengameh;Baghban, Alireza Akbarzadeh;Dianat, Omid
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.5
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    • pp.339-348
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    • 2022
  • Background: To compare the anesthetic efficacy of supplemental buccal infiltration (BI) (1.7 ml) versus intraligamentary (IL) injection containing 0.4 ml of 4% articaine with 1:100.000 epinephrine after an inferior alveolar nerve block (IANB) with 1.7 ml 2% lidocaine in the first and second mandibular molars diagnosed with irreversible pulpitis (IP). Methods: One hundred subjects diagnosed with IP of either the mandibular first (n = 50) or second molars (n = 50) and failed profound anesthesia following an IANB were selected. They randomly received either the IL or BI techniques of anesthesia. Pain scores on a 170 mm Heft-Parker visual analog scale were recorded initially, before, and during supplemental injections. Furthermore, pulse rate was measured before and after each supplemental injection. During the access cavity preparation and initial filing, no or mild pain was assumed to indicate anesthetic success. The chi-square test, Mann-Whitney U test, and independent samples t-test were used for the analyses. Results: The overall success rates were 80% in the IL group and 74% in the BI group, with no significant difference (P = 0.63). In the first molars, there was no significant difference between the two techniques (P = 0.088). In the second molars, IL injection resulted in a significantly higher success rate (P = 0.017) than BI. IL injection was statistically more successful (P = 0.034) in the second molars (92%) than in the first molars (68%). However, BI was significantly more successful (P = 0.047) in the first molars (88%) than in the second molars (64%). The mean pulse rate increase was significantly higher in the IL group than in the BI group (P < 0.001). Conclusions: Both the IL and BI techniques were advantageous when used as supplemental injections. However, more favorable outcomes were observed when the second molars received IL injection and the first molars received BI.

Programmed-release intraosseus anesthesia as an alternative to lower alveolar nerve block in lower third molar extraction: a randomized clinical trial

  • Pol, Renato;Ruggiero, Tiziana;Bezzi, Marta;Camisassa, Davide;Carossa, Stefano
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.3
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    • pp.217-226
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    • 2022
  • Background: Intraosseous anesthesia is the process by which an anesthetic solution, after penetration of the cortical bone, is directly injected into the spongiosa of the alveolar bone supporting the tooth. This study aimed to compare the effectiveness of the traditional inferior alveolar nerve block (IANB) and computerized intraosseous anesthesia in the surgical extraction of impacted lower third molars, compare their side effects systemically by monitoring heart rate, and assess patients' a posteriori preference of one technique over the other. Methods: Thirty-nine patients with bilaterally impacted third molars participated in this study. Each patient in the sample was both a case and control, where the conventional technique was randomly assigned to one side (group 1) and the alternative method to the contralateral side (group 2). Results: The traditional technique was faster in execution than anesthesia delivered via electronic syringe, which took 3 min to be administered. However, it was necessary to wait for an average of 6 ± 4 min from the execution to achieve the onset of IANB, while the latency of intraosseous anesthesia was zero. Vincent's sign and lingual nerve anesthesia occurred in 100% of cases in group 1. In group 2, Vincent's sign was recorded in 13% of cases and lingual anesthesia in four cases. The average duration of the perceived anesthetic effect was 192 ± 68 min in group 1 and 127 ± 75 min in group 2 (P < 0.001). The difference between the heart rate of group 1 and group 2 was statistically significant. During infiltration in group 1, heartbeat frequency increased by 5 ± 13 beats per minute, while in group 2, it increased by 22 ± 10 beats per minute (P < 0.001). No postoperative complications were reported for either technique. Patients showed a preference of 67% for the alternative technique and 20% for the traditional, and 13% of patients were indifferent. Conclusion: The results identified intraosseous anesthesia as a valid alternative to conventional anesthesia in impacted lower third molar extraction.

Improved postoperative recovery profile in pediatric oral rehabilitation with low-dose dexmedetomidine as an opioid substitute for general anesthesia: a randomized double-blind clinical trial

  • Naveen, Naik B;Jaiswal, Manoj Kumar;Ganesh, Venkata;Singh, Ajay;Meena, Shyam Charan;Amburu, Vamsidhar;Soni, Shiv Lal
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.5
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    • pp.357-367
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    • 2022
  • Background: Low-dose dexmedetomidine may be a suitable alternative to opioids for pediatric ambulatory procedures under general anesthesia (GA). However, the recovery profile remains unclear. Herein, we aimed to evaluate the effects of low-dose dexmedetomidine on the recovery profile of children. Methods: Seventy-two children undergoing ambulatory oral rehabilitation under GA were randomly and equally distributed into two groups (D and F). Group D received an infusion of dexmedetomidine 0.25 ㎍/kg for 4 min for induction, followed by maintenance of 0.4 ㎍/kg/h. Group F received an infusion of fentanyl 1 ㎍/kg over 4 min for induction, followed by maintenance at 1 ㎍/kg/h. The primary outcome was the extubation time. The secondary outcomes were awakening time, end-tidal sevoflurane (ET-Sevo) requirement, change in hemodynamic parameters, Richmond Agitation-Sedation Scale (RASS), Children's Hospital of Eastern Ontario pain scale (CHEOPS) score, length of PACU stay, and incidence of adverse events. Results: Statistically significant differences were observed in the recovery profile between the groups: the median time for extubation was 3.65 (3.44-6.2) vs. 6.25 (4.21-7) minutes in groups D vs. F (P=0.001), respectively, while the corresponding awakening times were 19 (18.75-21) and 22.5 (22-24) minutes, respectively (P < 0.001). The mean ET-Sevo was low in group D (1.1 vs. 1.2; P < 0.001). The heart rate was significantly low across all time points in group D, without resulting in bradycardia. The median RASS and CHEOPS scores were also significantly lower in group D. No significant differences were observed in the mean arterial pressure, incidence of adverse events, or length of PACU stay. Conclusion: Low-dose dexmedetomidine was more effective than fentanyl as an opioid substitute at providing a better recovery profile in pediatric ambulatory oral rehabilitation under GA. Dexmedetomidine also significantly reduced sevoflurane consumption without causing adverse events or prolonging hospital stay.

Comparison of ultrasound-guided subacromial corticosteroid and ozone (O2-O3) injections in the treatment of chronic rotator cuff tendinopathy: a randomized clinical trial

  • Merve Orucu Atar;Nurdan Korkmaz;Sefa Gumruk Aslan;Ozge Tezen;Sinem Uyar Koylu;Yasin Demir;Serdar Kesikburun
    • The Korean Journal of Pain
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    • v.36 no.1
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    • pp.128-136
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    • 2023
  • Background: The authors aimed to compare the effects of a one-time ultrasound (US)-guided subacromial corticosteroid injection and three-time ozone (O2-O3) injection in patients with chronic supraspinatus tendinopathy. Methods: Participants were randomly assigned to the corticosteroid group (n = 22) or ozone group (n = 22). Injections in both groups were administered into subacromial bursa with an US-guided in-plane posterolateral approach. Primary outcome measure was the change in the Western Ontario Rotator Cuff Index (WORC) score between baseline and 12-weeks post-injection. Secondary outcome measures included visual analog scale and Shoulder Pain and Disability Index scores. Assessments were recorded at baseline, and 4-weeks and 12-weeks post-injection. Results: Forty participants completed this study. Based on repeated measurement analysis of variance, a significant effect of time was found for all outcome measures in both groups. Both the groups showed clinically significant improvements in shoulder pain, quality of life, and function. Baseline, 4-week post-injection, and 12-week post-injection WORC scores (mean ± standard deviation) were 57.91 ± 18.97, 39.10 ± 20.50 and 37.22 ± 27.31 in the corticosteroid group, respectively and 69.03 ± 15.89, 39.11 ± 24.36, and 32.26 ± 24.58 in the ozone group, respectively. However, no significant group × time interaction was identified regarding all outcome measures. Conclusions: Three-time ozone injection was not superior to a one-time corticosteroid injection in patients with chronic supraspinatus tendinopathy. It might be as effective as corticosteroid injection at 4-weeks and 12-weeks post-injection in terms of relieving pain and improving quality of life and function.

Incidence of postoperative pain after using single continuous, single reciprocating, and full sequence continuous rotary file system: a prospective randomized clinical trial

  • Umesh Kumar;Pragnesh Parmar;Ruchi Vashisht;Namita Tandon;Charan Kamal Kaur
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.23 no.2
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    • pp.91-99
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    • 2023
  • Background: Extrusion of debris is a major factor that results in postoperative pain during root canal treatment with various instruments and instrumentation techniques. Therefore, instrumentation techniques that extrude minimal debris into the periapical area while reducing pain are desirable. This study aimed to compare the incidence of postoperative pain and intake of analgesic medication (frequency and quantity) after endodontic treatment of mandibular posterior teeth using two single files and full-sequence continuous rotary systems with different kinematic motions. Methods: Thirty-five of 105 patients were assigned equally to three groups according to the instrumentation system used: ProTaper Next (PN) X2, 25/06 (Dentsply, Maillefer, Ballaigues, Switzerland), One Shape (OS), #0.25/06 (Micro Mega, Besancon, France), and Wave One Gold (WG), Red - #0.25, 0.07 (Dentsply, Maillefer, Ballaigues, Switzerland). Five specialists were included in this study design; each professional prepared 21 teeth, and randomly selected 7 per instrument system. The VAS sheet ranging from 0 to 10 was used to record the initial and postoperative pains at 24, 48, and 72 h, and 7th day after single visit endodontic treatment in mandibular premolars and molars with a diagnosis of asymptomatic irreversible pulpitis with or without apical periodontitis. Postoperatively, an analgesic, ibuprofen 400 mg was administered for intolerable pain at a dose of 1 tablet for 6 h. The patients were asked over the telephone regarding postoperative pain at intervals of 24, 48, and 72 h, and 7th day using a visual analogue scale. Result: There were no statistically significant differences among the PN, OS, and WG systems (P > 0.05) with regard to the incidence of postoperative pain at any of the four time points assessed. Conclusion: The intensity of postoperative pain, frequency, and analgesic intake were similar across all three types of instrument systems; however, the reciprocating single file (WG) was associated with less postoperative pain than the full sequence continuous rotary file.

Orthodontic pain control following arch wire placement; a comparison between pre-emptive tenoxicam and chewing gum: a randomized clinical trial

  • Basam, Lakshman Chowdary;Singaraju, Gowri Sankar;Obili, Sobitha;Keerthipati, Thejasree;Basam, Ram Chowdary;Prasad, Mandava
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.2
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    • pp.107-116
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    • 2022
  • Background: Pain during fixed orthodontic treatment can have a detrimental effect on patient treatment compliance. To overcome this, there is a definite need to establish the best pain-relieving methods suitable for orthodontic patients in terms of efficacy and use. The objective of this study was to compare the effect of chewing gum and pre-emptive tenoxicam on pain after initial archwire placement and to evaluate the pain perceptions of orthodontic patients in the two groups while performing various functions at specific time intervals. Methods: Forty-two patients were selected and randomly divided into two groups: group A (chewing gum) and group B (pre-emptive tenoxicam). Pain perception was documented by patients immediately; at 4 h; at bedtime on the day of archwire placement; the next morning; at 24 h; and at bedtime on the 2nd, 3rd, and 7th day after the initial archwire placement. Pain scores were noted during fitting of the posterior teeth, biting, and chewing using a visual analog scale. The data obtained were subjected to statistical analysis. Results: Group A showed a significant increase in pain until the next morning while fitting the posterior teeth, biting, and chewing [36.2, 52.0, 33.4, respectively]], followed by a gradual decrease by the 7th day. Group B showed a significant increase in pain at bedtime on biting, with a peak value of 47.5. Pain on chewing, fitting posterior teeth, peaked the morning of the next day (100.0, 45.0). The Freidman test showed a statistically significant difference with a p-value of < 0.01. Higher pain scores were observed while chewing and biting compared with that while fitting the posterior teeth in both groups. The overall comparison of pain control between the two groups was not statistically significant [P > 0.05] between the two groups. Conclusions: Chewing gum was not inferior to pre-emptive tenoxicam. Thus, chewing gum is a non-pharmacological alternative to analgesics for orthodontic pain control that eliminates the chance of adverse reactions and can be used in the absence of adult observation.

Efficacy and Safety of Combination Treatment of Traditional Korean Medicine after Gastric Cancer Surgery: A Systematic Review and Meta-analysis Protocol (위암 수술 후 항암치료를 병행한 한의치료의 유효성 및 안전성: 체계적 문헌고찰 및 메타분석 프로토콜)

  • Jong-hee Kim;Eunbin Kwag;So-jung Park;Donghyun Kim;Soodam Kim;Jihye Park;Hwa-seung Yoo
    • Herbal Formula Science
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    • v.31 no.4
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    • pp.361-371
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    • 2023
  • Objectives : Gastric cancer is a malignant tumor of the digestive tract that not only has a high mortality rate, but also affects quality of life. In Traditional Korean Medicine, acupuncture and herbal medicines can increase the survival rate for Gastric cancer and improve the quality of life. Traditional Korean Medicine treatment played an important role when used alone or in combination with chemotherapy. However, there is still insufficient evidence to support the efficacy and safety of Traditional Korean Medicine in patients undergoing chemotherapy after surgery. Therefore, the purpose of this study is to systematically evaluate the effect of oriental medicine treatment on patients as a complementary therapy for Gastric cancer. Methods : 2 researchers will search using EMBASE, Pubmed, CNKI, Cochrane Library, CiNii, KMBASE, KISS, OASIS, RISS, ScienceON. The search period of the database is from inception until June 2022. This study will include a randomized controlled trial of GC for acupuncture and herbal treatment. Primary outcomes include anti-cancer effects. Secondary outcomes evaluate survival rates and improvements in quality of life. The data uses Review Manager Software 5.4. Results : This study will provide a systematic evaluation by synthesizing the anti-cancer effect, survival rate and quality of life of Gastric cancer when Traditional Korean Medicine is combined with chemotherapy. Conclusion : The conclusion of this study will provide a basis for determining whether Traditional Korean Medicine treatment for Gastric cancer treatment is an effective and safe treatment method in clinical practice.

Neuroimaging Assessment of the Therapeutic Mechanism of Acupuncture and Bee Venom Acupuncture in Patients with Idiopathic Parkinson's Disease: A Double-blind Randomized Controlled Trial

  • Young-Eun Lee;Seung-Yeon Cho;Han-Gyul Lee;Seungwon Kwon;Woo-Sang Jung;Sang-Kwan Moon;Jung-Mi Park;Chang-Nam Ko;Seong-Uk Park
    • The Journal of Korean Medicine
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    • v.44 no.4
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    • pp.104-120
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    • 2023
  • Objectives: The purpose of this study was to explore the therapeutic mechanism of acupuncture and bee venom acupuncture (BVA) in patients with idiopathic Parkinson's disease (IPD) using positron emission tomography (PET) and arterial spin labeling (ASL). Methods: Patients with IPD who received a stable dose of anti-parkinsonian medication for at least 4 weeks were recruited and randomly divided into one of two groups: treatment and control. The treatment group (11 subjects) received acupuncture and BVA at acupoints, and the control group (9 subjects) received sham acupuncture and normal saline injections at non-acupoints, twice per week for 12 weeks. The patients were examined using PET and ASL at baseline and after the 12-week treatment. In addition, age- and sex-matched healthy subjects without neurological symptoms and history were recruited to compare ASL data of patients with IPD. Results: PET results revealed that striatal dopamine transporter binding increased in each group after 12 weeks. Although the change was larger in the treatment group, the difference was not statistically significant. In ASL results, the treatment group exhibited hyperperfusion in specific regions compared with the healthy control group. After 12 weeks' intervention, hyperperfusion regions were recovered only in the treatment group. In contrast, significant changes were not found in hyperperfusion regions in the control group after 12 weeks. Conclusions: Our findings suggest that the therapeutic mechanisms of acupuncture and BVA in IPD are different from placebo and operate by altering dopamine availability and recovering hyperactivity in cerebral blood flow.

Identification of an effective and safe bolus dose and lockout time for patient-controlled sedation (PCS) using dexmedetomidine in dental treatments: a randomized clinical trial

  • Seung-Hyun Rhee;Young-Seok Kweon;Dong-Ok Won;Seong-Whan Lee;Kwang-Suk Seo
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.24 no.1
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    • pp.19-35
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    • 2024
  • Background: This study investigated a safe and effective bolus dose and lockout time for patient-controlled sedation (PCS) with dexmedetomidine for dental treatments. The depth of sedation, vital signs, and patient satisfaction were investigated to demonstrate safety. Methods: Thirty patients requiring dental scaling were enrolled and randomly divided into three groups based on bolus doses and lockout times: group 1 (low dose group, bolus dose 0.05 ㎍/kg, 1-minute lockout time), group 2 (middle dose group, 0.1 ㎍/kg, 1-minute), and group 3 (high dose group, 0.2 ㎍/kg, 3-minute) (n = 10 each). ECG, pulse, oxygen saturation, blood pressure, end-tidal CO2, respiratory rate, and bispectral index scores (BIS) were measured and recorded. The study was conducted in two stages: the first involved sedation without dental treatment and the second included sedation with dental scaling. Patients were instructed to press the drug demand button every 10 s, and the process of falling asleep and waking up was repeated 1-5 times. In the second stage, during dental scaling, patients were instructed to press the drug demand button. Loss of responsiveness (LOR) was defined as failure to respond to auditory stimuli six times, determining sleep onset. Patient and dentist satisfaction were assessed before and after experimentation. Results: Thirty patients (22 males) participated in the study. Scaling was performed in 29 patients after excluding one who experienced dizziness during the first stage. The average number of drug administrations until first LOR was significantly lower in group 3 (2.8 times) than groups 1 and 2 (8.0 and 6.5 times, respectively). The time taken to reach the LOR showed no difference between groups. During the second stage, the average time required to reach the LOR during scaling was 583.4 seconds. The effect site concentrations (Ce) was significantly lower in group 1 than groups 2 and 3. In the participant survey on PCS, 8/10 in group 3 reported partial memory loss, whereas 17/20 in groups 1 and 2 recalled the procedure fully or partially. Conclusion: PCS with dexmedetomidine can provide a rapid onset of sedation, safe vital sign management, and minimal side effects, thus facilitating smooth dental sedation.