Action of ear acupuncture in people with chronic pain in the spinal column: a randomized clinical trial

ABSTRACT Objectives: to assess the action of ear acupuncture on disability and tissue temperature in people with chronic pain in the spinal column. Method: a clinical trial with a sample of 110 people, randomized into three groups: Treatment, Placebo and Control. The assessment instruments were the Rolland Morris Disability Questionnaire (RMDQ) and a thermographic camera, administered before the first treatment session, one week after and 15 days after (follow-up) the fifth session of ear acupuncture. In the analysis of the data, the Kruskal Wallis, Student-Newman Keuls and Wilcoxon tests were applied. Results: there was a significant reduction in disability in the Treatment and Placebo groups between the initial and final assessments (p<0.05) and between the initial assessments and follow-up (p<0.05). In the final assessment, the Treatment group presented improvement of disability when compared with the Placebo and Control groups (p<0.05). There was an increase in mean tissue temperature of the dorsal region between the initial and follow-up assessments in Treatment and Control groups (p<0.05), and between the final assessments and follow-up in the Treatment and Placebo groups (p<0.05). Conclusion: ear acupuncture was efficacious in reducing disability and increasing tissue temperature in people with chronic pain in the spinal column. Brazilian Register of Clinical Trials (RBR-5X69X2).

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Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial

Journal of Neurosurgery Spine ◽

10.3171/2014.6.spine13996 ◽

2014 ◽

Vol 21 (4) ◽

pp. 516-528 ◽

Cited By ~ 128

Author(s):

J. Kenneth Burkus ◽

Vincent C. Traynelis ◽

Regis W. Haid ◽

Praveen V. Mummaneni

Keyword(s):

Clinical Trial ◽

Surgical Procedures ◽

Neck Disability Index ◽

Cervical Disc ◽

Control Group ◽

Control Groups ◽

Neck Disability ◽

And Control ◽

The Prestige

Object The authors assess the long-term safety and efficacy of cervical disc replacement with the Prestige Cervical Disc in a prospective, randomized, multicenter trial at 7 years of follow-up. Methods At 31 investigational sites, 541 patients with single-level cervical disc disease with radiculopathy were randomized to 1 of 2 treatment groups: 276 investigational group patients underwent anterior cervical discectomy and arthroplasty with the Prestige disc, and 265 control group patients underwent anterior cervical discectomy and fusion. Clinical outcomes included Neck Disability Index, the 36-Item Short-Form Health Survey, and neck and arm pain scores. Radiographs were assessed for angle of motion and fusion. Clinical and radiographic outcomes were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, 60, and 84 months. Results Of the 541 patients treated, 395 patients (73%; 212 investigational and 183 control patients) completed 7 years of clinical follow-up. Significant improvements achieved by 1.5 months in both groups were sustained at 7 years. In the investigational group, mean Neck Disability Index improvements from preoperative scores were 38.2 and 37.5 at 60 and 84 months, respectively. In the control group, the corresponding means were 33.8 and 31.9. The differences between the investigational and control groups at the 60-month and 84-month periods were significant (p = 0.014 and 0.002, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were significantly higher: 92.2% and 88.2% at 60 months and 84 months, respectively, compared with 85.7% and 79.7% in the control group (p = 0.017 and 0.011, respectively). At 84 months, the percentage of working patients in the investigational group was 73.9%, and in the control group, 73.1%. Postoperatively, the implant effectively maintained average angular motion of 6.67° at 60 months and 6.75° at 84 months. Cumulative rates for surgery at the index level were lower (p < 0.001) in the investigational group (11 [4.8%] of 276) when compared with the control group (29 [13.7%] of 265) (based on life-table method), and there were statistical differences between the investigational and control groups with specific regard to the rate of subsequent revision and supplemental fixation surgical procedures. Rates for additional surgical procedures that involved adjacent levels were lower in the investigational group than in the control group (11 [4.6%] of 276 vs 24 [11.9%] of 265, respectively). Conclusions Cervical disc arthroplasty has the potential for preserving motion at the operated level while providing biomechanical stability and global neck mobility and may result in a reduction in adjacent-segment degeneration. The Prestige Cervical Disc maintains improved clinical outcomes and segmental motion after implantation at 7-year follow-up. Clinical trial registration no. NCT00642876 (ClinicalTrials.gov).

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A randomized trial of levamisole versus placebo as adjuvant therapy in malignant melanoma.

Journal of Clinical Oncology ◽

10.1200/jco.1991.9.5.736 ◽

1991 ◽

Vol 9 (5) ◽

pp. 736-740 ◽

Cited By ~ 59

Author(s):

L E Spitler

Keyword(s):

Malignant Melanoma ◽

Adjuvant Therapy ◽

Randomized Trial ◽

Control Groups ◽

Disease Free Interval ◽

Significant Difference ◽

Long Term Follow Up ◽

And Control

We conducted a long-term follow-up (median, 10.5 years) of patients included in a randomized trial of levamisole versus placebo as surgical adjuvant therapy in 203 patients with malignant melanoma. Of the patients randomized, 104 received levamisole, and 99 received placebo. The results show that there is no difference between the treatment and control groups with regard to any of the three end points analyzed. These included disease-free interval, time to appearance of visceral metastasis, and survival. Moreover, there was no significant difference between the treatment and control groups after adjusting for age, sex, or stage of disease.

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Striatal glutamate and the conversion to psychosis: a prospective 1H-MRS imaging study

The International Journal of Neuropsychopharmacology ◽

10.1017/s1461145712000314 ◽

2012 ◽

Vol 16 (2) ◽

pp. 471-475 ◽

Cited By ~ 60

Author(s):

Camilo de la Fuente-Sandoval ◽

Pablo León-Ortiz ◽

Mariana Azcárraga ◽

Rafael Favila ◽

Sylvana Stephano ◽

...

Keyword(s):

Proton Magnetic Resonance ◽

Proton Magnetic Resonance Spectroscopy ◽

Imaging Study ◽

Psychotic Symptoms ◽

Resonance Spectroscopy ◽

Control Groups ◽

1H Mrs ◽

Ultra High Risk ◽

And Control

Abstract Increased glutamate levels in the associative-striatum have been described in subjects at ultra-high risk for psychosis (UHR); nevertheless, it is unclear whether this abnormality predicts the conversion to psychosis. Nineteen subjects at UHR and 26 controls were studied using proton magnetic resonance spectroscopy. Subjects at UHR were clinically followed for 2 yr. Seven UHR subjects (37%) transitioned to a psychotic disorder and the remaining 12 did not exhibit psychotic symptoms at the most recent follow-up. The psychosis transition group had higher glutamate levels compared to both non-transition and control groups (p = 0.02 and p < 0.01, respectively; effect size 1.39). These pilot findings suggest that the conversion to psychosis is associated with increased glutamate levels in the associative-striatum.

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Personality traits of the chronic pain population comparatively to neurotic and control groups

Pain ◽

10.1016/0304-3959(81)90286-4 ◽

1981 ◽

Vol 11 ◽

pp. S69

Author(s):

J. Barg ◽

A. Perez ◽

C. Main ◽

M. R. Bond

Keyword(s):

Chronic Pain ◽

Personality Traits ◽

Control Groups ◽

And Control

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An Improved Model for Evaluating Change in Randomized Pretest, Posttest, Follow-Up Designs

Methodology ◽

10.1027/1614-2241/a000041 ◽

2012 ◽

Vol 8 (3) ◽

pp. 97-103 ◽

Cited By ~ 4

Author(s):

Constance A. Mara ◽

Robert A. Cribbie ◽

David B. Flora ◽

Cathy LaBrish ◽

Laura Mills ◽

...

Keyword(s):

Monte Carlo Simulation ◽

Monte Carlo ◽

Group Differences ◽

Primary Research ◽

Control Groups ◽

Proposed Model ◽

Research Questions ◽

Improved Model ◽

And Control

Randomized pretest, posttest, follow-up (RPPF) designs are often used for evaluating the effectiveness of an intervention. These designs typically address two primary research questions: (1) Do the treatment and control groups differ in the amount of change from pretest to posttest? and (2) Do the treatment and control groups differ in the amount of change from posttest to follow-up? This study presents a model for answering these questions and compares it to recently proposed models for analyzing RPPF designs due to Mun, von Eye, and White (2009) using Monte Carlo simulation. The proposed model provides increased power over previous models for evaluating group differences in RPPF designs.

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Effectiveness of a Need-Based Program in Relieving Psychological Distress of Family Caregivers of Leukemia Patients: A Randomized Clinical Trial

10.21203/rs.3.rs-219088/v1 ◽

2021 ◽

Author(s):

Mehrdad Abdullahzadeh ◽

Narjes Khosravi

Keyword(s):

Clinical Trial ◽

Psychological Distress ◽

Family Caregivers ◽

Psychological Needs ◽

Anxiety And Depression ◽

Study Group ◽

Control Groups ◽

Significant Difference ◽

The Mean ◽

And Control

Abstract PurposeThe family of leukemia patients, due to their caring role, often feel psychological distress. This paper describes the efficacy of a designed family-need-based program on relieving depression, anxiety, and stress of family caregivers of leukemia patients by meeting the specific psychological needs of caregivers.MethodsIn this clinical trial, 64 family caregivers of leukemia patients referring to a medical center in Iran were recruited by convenience sampling and divided into study and control groups randomly. The study group attended a designed need-based program. The control group did not receive the intervention. Stress, anxiety, and depression before, right after, and one month after the intervention in family caregivers were compared using DASS-42. Data were analyzed using descriptive and inferential statistics; the significance level adopted was 5%.ResultsBefore the intervention, the mean score of depression, anxiety, and stress scale in both study and control groups showed no considerable difference (P > 0.05). After the intervention, the mean score of DASS-42 revealed a significant difference between the two groups and the study group did better on outcomes (P < 0.001).ConclusionThis family-need-based program can decrease the level of stress, anxiety, and depression of the family caregivers of leukemia patients and may potentially alleviate the psychological distress of family caregivers over their caring role.Trial registration number: IRCT2013093011895N2. Date of registration: 2014-05-06

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Olfactory Dysfunction in β Thalassemia Major Patients Treated With Iron-Chelating Agents

Ear Nose & Throat Journal ◽

10.1177/0145561319840079 ◽

2019 ◽

Vol 98 (8) ◽

pp. NP125-NP130

Author(s):

Serhan Derin ◽

Selvet Erdogan ◽

Murat Sahan ◽

Mehmet Fatih Azik ◽

Hatice Derin ◽

...

Keyword(s):

Chelating Agents ◽

Thalassemia Major ◽

Olfactory Dysfunction ◽

Facial Trauma ◽

Control Group ◽

Control Groups ◽

History Of ◽

And Control ◽

Iron Chelating Agents

Ocular and ophthalmological adverse effects may be seen in β-thalassemia major (BTM) patients treated with regular blood transfusions and iron-chelating agents. We hypothesized that olfactory dysfunction may be present in this population. In this study, we aimed to investigate olfactory dysfunction in patients with BTM and determine the etiological factors. A total of 43 patients with BTM were included in the study. Forty-three patients without any nasal complaints, history of facial trauma, or nasal surgery were included as the controls. All participants had nasal endoscopy. The iron-chelating agents used, their duration of use, as well as hemoglobin and ferritin levels of the BTM patients were recorded. Sniffin’ Sticks test (SST) was used to assess olfactory functions, and BTM and control groups were compared for the results. The correlations of SST scores with the other study parameters were analyzed. Eight (18.6%) of 43 patients in the BTM group had hyposmia while none of the patients in the control group had hyposmia ( P < .001). Older age, low-hemoglobin level, and longer use of deferoxamine were found to be correlated with olfactory dysfunction. Olfactory dysfunction may be seen in BTM patients treated with iron-chelating agents. The results of this study suggest that screening for olfactory function may be needed in routine follow-up of BTM patients.

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Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2017-0085 ◽

2018 ◽

Vol 15 (3) ◽

Author(s):

Mansoor Keshavarz ◽

Maryam Kashanian ◽

Soodabeh Bioos ◽

Yasaman Vazani

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Active Phase ◽

Obstetric Outcomes ◽

Control Group ◽

Control Groups ◽

Persian Medicine ◽

Traditional Persian Medicine ◽

And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

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Time taken to resume driving following hip arthroscopy

BMC Musculoskeletal Disorders ◽

10.1186/s12891-020-03662-y ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Suenghwan Jo ◽

Sang Hong Lee ◽

Se Woong Jang ◽

Hyun Bai Choi ◽

Ba Rom Kim ◽

...

Keyword(s):

Hip Arthroscopy ◽

Driving Simulator ◽

Driving Performance ◽

Control Group ◽

Control Groups ◽

Test Protocol ◽

Surgery Group ◽

Time Required ◽

And Control

Abstract Background Resuming driving is a common concern among patients undergoing hip arthroscopy. The present study aimed to assess whether patients who had undergone right hip arthroscopy presented with poorer driving performance than patients with normal hips and to analyze the time required to regain preoperative driving performance. Methods Forty-seven patients who had undergone right hip arthroscopy and consented to our test protocol were included in this study. Using an immersive driving simulator, the patients were tested for their brake reaction time (BRT), total brake time (TBT), and brake pedal depression (BPD) preoperatively and postoperatively. The first postoperative assessments were conducted when the patients could comfortably sit on the driving seat, and the follow-up assessments were conducted for 6 consecutive weeks at weekly intervals. The patients were divided into the following two groups based on the type of surgery that they underwent: the femoroacetabular impingement (FAI) surgery group and the simple hip arthroscopy (SA) group. Twenty healthy volunteers underwent driving assessments thrice at weekly intervals and constituted the control group. The braking parameters were compared between preoperative and postoperative measurements and among the FAI surgery, SA, and control groups. Results The preoperative braking parameters of the patients who underwent arthroscopy did not differ significantly from those of the controls (p = 0.373, 0.763, and 0.447 for the BRT, TBT, and BPD, respectively). All braking parameters returned to normal in 2 weeks in the FAI surgery group and in 1 week in the SA group. Conclusions Our study suggests that the driving performance of patients who underwent right hip arthroscopy is comparable to that of individuals with normal hips and that the braking parameters may normalize to the preoperative state at 1 week after SA and 2 weeks after FAI surgery.

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Piano-accompanied solfège reading experiences of preservice music teachers

Research Studies in Music Education ◽

10.1177/1321103x19871078 ◽

2020 ◽

pp. 1321103X1987107

Author(s):

Elif Guven

Keyword(s):

Music Teachers ◽

Control Group ◽

Reading Practices ◽

Control Groups ◽

Plot Analysis ◽

Experimental Implementation ◽

Significant Difference ◽

And Control ◽

Experimental Group

This study examines how piano-accompanied solfège reading practices of preservice music teachers ( N = 28) affect their performance on their musical hearing, reading, and writing (MHRW) classes. A pretest–posttest design with control groups was employed. The data were analyzed by 2 × 2 split-plot analysis of variance (ANOVA) and one-way ANOVA. Consequently, a significant difference was not found between the MHRW performance scores of the experimental and control groups. An analysis of mean performance scores revealed that the scores received by the control group were higher than those of the experimental group after the practice. Follow-up interviews that were held with 14 students after the experimental implementation revealed that students believed piano-accompanied courses were more useful, and they felt more comfortable with piano accompaniment. Although MHRW performance scores indicated that piano-accompanied solfège reading practices did not have a significant effect on preservice music teachers’ MHRW performances, it helped them participate in courses more enthusiastically.

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