• Title/Summary/Keyword: Clinical Trial Design

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Reliability and validity of the patellofemoral disability index as a measure of functional performance and subjective pain in subjects with patellofemoral pain syndrome

  • Alshaharani, Mastour Saeed;Lohman, Everett Bernell;Bahjri, Khaled;Harp, Travis;Alameri, Mansoor;Daher, Noha S.
    • Physical Therapy Rehabilitation Science
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    • v.7 no.2
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    • pp.61-66
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    • 2018
  • Objective: Patellofemoral pain syndrome (PFPS) is a condition that is characterized by patellar discomfort or pain that is aggravated during certain activities such as ascending/descending stairs. The Patellofemoral Disability Index (PDI) was developed to assess the effect of pain on functional activities in individuals with PFPS. The objectives of the current study were to determine the internal consistency, test-retest reliability, and validity of this index. Design: Cross-sectional study. Methods: Forty-one subjects who had PFPS with a mean age of $28.8{\pm}5.0years$ and a mean body mass index of $25.6{\pm}4.7kg/m^2$ participated in the study. All subjects were concurrently enrolled in a clinical trial for which they were instructed to complete hamstring-resistance exercises for 4 weeks. Over the course of the intervention, they completed both the PDI and the Oswestry Disability Index (ODI) at baseline after two weeks, and after four weeks. Pearson correlation coefficient was used to assess the criterion validity. Cronbach's ${\alpha}$ was used to examine the internal consistency. Intraclass correlation coefficients with 95% confidence interval were computed to examine test-retest reliability. Results: Subjects' responses within both the PDI and the ODI yielded Pearson correlation coefficient values that were positive and highly significant (range, 0.73-0.97; p<0.001). There was a high level of internal consistency (Cronbach's ${\alpha}{\geq}0.8$), with the exception of stair climbing (Cronbach's ${\alpha}=0.65$). Intraclass correlation ranged from 0.87 to 0.92, indicating high levels of test-retest reliability. Conclusions: The PDI is a valid, reliable, and feasible method of assessing pain and functional ability in patients with PFPS.

Quantity and Quality Assessment of Randomized Controlled Trials in the Atopic Dermatitis (아토피 피부염 무작위배정 임상연구 논문 질 평가)

  • Park, Hye-Joo;Kwon, Ji-Hye;Yoo, Jong-Hyang
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.27 no.4
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    • pp.45-57
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    • 2014
  • Objective : This study aims to provide fundamental data for new directions(the improvement directions) from searching research papers of randomized controlled trials among thesis of Atopic Dermatitis related to oriental medicine in Korea from 2004 to 2014 and identifying the problem and level of a clinical study through an assessment of the quality, CONSORT statement. Methods : Data was collected through the Koreanstudies Information Service System(KISS). Two experts in Oriental Medicine reviewed the title and abstract in thesis, the results of searching the title, "Atopic dermatitis" and topic, "oriental medicine" at KISS, and then they handsearched Randomized Controlled Trials related to oriental medicine in Korea. According to guidelines defined by CONSORT statement, they assessed whether 37 items were followed by guidelines at yes or no answers in order to evaluate the quality as well. They assessed the definition of each item independently. After comparing, they made a decision on the item of different outcomes through an agreement with a third party. Results : Total number of randomized controlled trials in Atopic Dermatitis related to oriental medicine is eleven. A randomized controlled trial was first published in 2007. One or two papers associated it were released every year except 2013. 9 papers of them were approved by Institutional Review Board and were received written consent. The study included between 20 to 40 subjects for 2-arm parallel study design. The effect of treatment was observed for 4 to 8 weeks. On average, the number followed guidelines was 18.64 among those of 37 CONSORT statement and 50.38% of them was followed overall. Conclusion : As an interest about randomized controlled trials was increased, it was needed to care the standard providing information of CONSORT statement on randomized controlled trials related to oriental medicine in Korea. It is suggested to provide more clear information about it, so that it can be a motive for improving quality of the journal in oriental medicine.

Effects of dynamic myofascial release on trunk mobility and standing balance in persons with chronic nonspecific low back pain

  • Lee, Dong-Woo;Shin, Hwa-Kyung;Kim, Kwang-Su
    • Physical Therapy Rehabilitation Science
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    • v.8 no.2
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    • pp.74-78
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    • 2019
  • Objective: Myofascial release (MFR) is used to restore tissue extensibility of the fascia tissue and is considered to be useful in a number of clinical settings, such as low back pain (LBP). Dynamic myofascial release (DMFR) is the manual therapy, which combined the conventional MFR with the joint mobilization. The purpose of this study was to investigate the effects of the DMFR on trunk mobility, and furthermore, whether the increase of trunk mobility can carry over the improvement of dynamic standing balance in persons with chronic nonspecific LBP. Design: Randomized controlled trial. Methods: Thirty persons with chronic non-specific LBP participated in the study and were randomly assigned to the DMFR group (n=15) or the control group (n=15). DMFR was performed for two sessions (15 minutes/session) per week for four weeks for the treatment group. Both the DMFR and control groups were allowed to perform low-intensity physical activities during the treatment period. The Modified-modified $Sch{\ddot{o}}ber$ test (MMST) for trunk mobility and the Functional Reach Test (FRT) for dynamic standing balance were measured before and after the treatment period in both the DMFR group and the control group. Results: The MMST value of DMFR group increased significantly in all trunk range of motion (flexion, extension, lateral flexion, and rotation) after treatment, compared with the control group (p<0.05). Additionally, the FRT value of the DMFR group improved significantly after treatment, compared with the control group (p<0.05). Conclusions: We suggest that DMFR have a positive effect on trunk mobility and standing balance in persons with chronic LBP.

Effect of Proprioceptive Neuromuscular Facilitation Chopping Pattern on Neglect, Balance, and Activity of Daily Living of Stroke Patients with Hemi-Spatial Neglect: A randomized clinical trial (고유수용성신경근촉진법 내려치기 패턴 훈련이 편측무시가 있는 뇌졸중 환자의 편측무시, 균형능력 및 일상생활수행능력에 미치는 영향: 무작위 임상 시험)

  • Kang, Tae-Woo;Kim, Beom-Ryong
    • Journal of the Korean Society of Physical Medicine
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    • v.14 no.2
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    • pp.107-115
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    • 2019
  • PURPOSE: This study examined the effects of the chopping pattern of proprioceptive neuromuscular facilitation (PNF) on the neglect, balance ability, and activities of daily living in stroke patients with hemi-spatial neglect. METHODS: Twenty stroke patients with neglect volunteered for this study. The subjects were assigned randomly to either the experimental group (EG, n=10) or control group (CG, n=10). The chopping pattern of PNF and exercise therapy were applied in the EG and CG, respectively, for four weeks. Neglect, balance, and activities of daily living were evaluated at the pre-and post-intervention. The assessment tools included a line-bisection test, balance test using Space balance 3D, and modified Barthel index. The pre-and post-intervention values were compared in each group using a paired t-test and the between-group differences were assessed using an independent t-test. Statistical significance was set to ${\alpha}=.05$ for all variables. RESULTS: Significant differences were observed between the EG and CG in terms of neglect, balance, and activities of daily living (p<.05). Both groups showed significant improvement in neglect, balance, and activities of daily living (p<.05). CONCLUSION: These results suggest that the chopping pattern of PNF is effective in improving the hemi-spatial neglect, balance, and activities of daily living in stroke patients with neglect.

Effects of mechanical intervention on cutaneous sensory change and pressure pain threshold in the same spinal segment of myofascial pain

  • Kim, Do Hyung;Lee, Su-Hyun;Lee, Byoung Hee
    • Physical Therapy Rehabilitation Science
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    • v.8 no.1
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    • pp.15-21
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    • 2019
  • Objective: The purpose of this study was to identify whether cutaneous sensory (CS) changes induced by mechanical intervention (MI) increases the trigger point threshold of the same spinal segment as well as to investigate the relationship between the amounts of change in CS pressure pain thresholds (PPT). Design: Randomized controlled trial. Methods: Thirty-nine persons with myofacial pain (MFP) were recruited in this experiment. The subjects consisted of 20 men and 19 women (age 20-39). MI was applied on the subjects using the Graston technique for 5 minutes to induce CS changes. The CS changes were measured with sensory tests by using the Von Frey Filament, and PPT changes were estimated by using the pressure threshold meter. For the observation of sensory and PPT changes with time, the test was conducted for 15 minutes including a pre, post, and after intervention session. Results: CS threshold increased significantly when MI was applied (p<0.001). On the same spinal segment, changes in the right infraspinatus PPT was observed (p<0.001) but the PPT changes in other muscles were not significantly different. Furthermore, the control group CS and PPT were not significantly different. In addition, regression analysis showed that the CS changes have a larger impact on PPT in the same spinal segment (p<0.001). Conclusions: CS changes induced by MI make to change PPT on the same spinal segment. In other words, it is possible to identify PPT changes following CS changes except for the muscle which belongs to a different spinal segment. Therefore, application of MI is necessary for the CS changes in the same spinal segment. Furthermore, it can be useful in the clinical fields as a method of providing pain control and increasing the PPT.

Effect of push-up plus exercise on shoulder stabilization muscle thickness in healthy adults in their twenties on various support surfaces (다양한 지지면에서 푸쉬업 플러스 운동이 20대 건강한 성인의 어깨 안정화 근육 두께에 미치는 영향)

  • Jeong, Jin Gyu;Park, Jae Cheol
    • Journal of Korean Physical Therapy Science
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    • v.29 no.3
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    • pp.48-55
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    • 2022
  • Background: The purpose of this study is to examine the effect of push-up plus exercise on the changes in the thickness of the trapezius trapezius, serratus anterior and pectoralis major muscles involved in shoulder stability in various support surfaces. Design: Randomized controlled trial. Methods: The thickness change of the shoulder stabilizing muscle was measured using an ultrasound device. Corresponding t-test was performed to confirm the change within the group before the experiment and after 5 weeks. And one-way ANOVA was used to confirm the change between groups after 5 weeks. As a post hoc test, the least significant difference test was performed, and the significance level was set to a=0.05. Results: Changes in the thickness of the trapezius muscle within the group were significantly different between UPEG and SPEG after 5 weeks (p<0.05), and there was a significant difference between groups after 5 weeks (p<0.05). Changes in the thickness of the serratus anterior and pectoralis major muscle within the group were significantly different after 5 weeks in PEG, UPEG and SPEG (p<0.05), and the changes between the groups were significantly different in the serratus anterior muscle after 5 weeks (p<0.05). Conclusion: From the results of this study, it was found that the push-up exercise on an unstable support surface was effective for strengthening the trapezius upper and serratus anterior. This study intends to suggest the possibility of application as basic data for a push-up plus exercise program in clinical practice.

Effects of a Complex Exercise Program using Dynamic Taping on Patients with Tension-Type Headache and Chronic Neck Pain with Forward Head Posture (다이나믹 테이핑을 적용한 복합 운동프로그램이 긴장성 두통과 전방머리자세를 동반한 만성 목 통증 환자에게 미치는 효과)

  • Park, Sam-Ho;Jung, Seung-Hwa
    • Journal of The Korean Society of Integrative Medicine
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    • v.10 no.4
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    • pp.23-34
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    • 2022
  • Purpose : This study examined the effects of pain, neck dysfunction, psychosocial level, headache impact test (HIT), postural alignment, and trapezius muscle tone of the complex exercise program using dynamic taping in patients with tension headache and chronic neck pain with forward head posture. Methods : The design of this is a randomized controlled trial (RCT). Thirty-four patients with chronic neck pain were screened using a randomized assignment program and assigned to experimental group (n=17) and control group (n=17). Both groups underwent a complex exercise program. In addition, the experimental group dynamic taping was applied to the upper trapezius muscle. All interventions were applied three times per week for four weeks. The visual analogue scale (VAS), the neck disability index (NDI), short form-12 health survey questionnaire (SF-12), Headache impact test-6 (HIT-6), Craniovertebral angle (CVA), Cranial rotation angle (CRA), upper trapezius muscle tone were compared to evaluate the effect on intervention. Results : Both groups showed significant differences before and after the intervention in VAS, NDI, SF-12, HIT-6, and CVA, CRA (p<.05). In addition, significant differences in NDI and upper trapezius muscle tone were observed between the experimental group and control group (p<.05). Conclusion : A complex exercise program using dynamic taping for patients with tension headache and chronic neck pain with forward head posture are effective method with clinical significance in improving the function and reducing upper trapezius muscle tone.

Effects of Upper Trapezius Inhibition Dynamic Taping on Pain, Function, Range of Motion, Psychosocial Status, and Posture of the Neck in Patients With Chronic Neck Pain (위등세모근 억제 다이나믹 테이핑이 만성 목 통증 환자들의 목 통증, 기능장애 수준, 관절가동범위, 심리사회적 수준, 목 자세정렬에 미치는 영향)

  • Yoon, Sang-woo;Kim, Suhn-yeop
    • Physical Therapy Korea
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    • v.29 no.1
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    • pp.1-10
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    • 2022
  • Background: Neck pain is a major health problem in developed countries and has a lifetime prevalence of 50%. Major problems include a reduced cervical range of motion, muscle stiffness, dysfunction, postural changes, and decrease in psychosocial level. Objects: This study aimed to investigate the effects of applying the upper trapezius inhibition dynamic taping to patients with chronic neck pain on their neck pain, functional level, cervical range of motion, psychosocial level, and neck posture. Methods: The study design was a randomized controlled trial. A total of 40 patients with neck pain participated in this study and were randomly assigned to a Dynamic Taping group (n = 20) or Sham Taping group (n = 20). In both groups, basic intervention cervical pain control therapy and shoulder stabilization exercise program were performed. In addition, dynamic taping and sham taping were applied to participants in the Dynamic Taping and Sham Taping groups to inhibit the trapezius muscle, respectively. All interventions were performed three times a week and a total of 12 times for 4 weeks, and the participants' neck pain, functional impairment level, cervical range of motion, psychosocial level, and neck posture were measured and compared before and after the intervention. Results: Both groups showed significant differences in neck pain, functional level, cervical range of motion, psychosocial level, and neck postural before and after the intervention (p < 0.05). Moreover, there were significant differences between the two groups regarding the functional level and neck posture (p < 0.05). Conclusion: Inhibition dynamic taping of the upper trapezius muscle suppression is an effective method with clinical significance in reducing pain in individuals with chronic neck pain and improving the functional level, cervical range of motion, psychosocial level, and neck posture.

Effects of High-Frequency Treatment using Radiofrequency on Autonomic Nervous System and Pain in Women with Dysmenorrhea

  • Sungeon Park;Seungwon Lee;Inok Kim
    • Physical Therapy Rehabilitation Science
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    • v.11 no.4
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    • pp.493-501
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    • 2022
  • Objective: The purpose of this study is to present basic data for appropriate therapeutic intervention by confirming changes in the autonomic nervous system and pain by applying high-frequency deep diathermy to the lower abdomen in patients with primary dysmenorrhea. Design: A randomized controlled clinical trial. Methods: Thirty-eight women aged 18-50 years who complained of regular menstrual cycles (24-32 days) and primary dysmenorrhea symptoms were randomly assigned to a high-frequency therapy group (5, 7, or 9 mins) and a superficial heat therapy group (20 min). High frequency treatment group: The subject was in a supine position, and radio frequency was applied to the lower abdomen below the umbilicus. The radio frequency therapy device used in this study uses a 300 kHz capacitive electrode and a 500 kHz resistive electric transfer to deliver deep heat. Superficial heat treatment Group: Subjects applied a hot pack to the lower abdomen for 20 minutes while lying on their back. Evaluations were made of Heart rate variability and Visual Analogue Scale. Results: In subjects with menstrual pain, there was a significant difference in pain between the high-frequency therapy group and the superficial heat therapy group (p=0.026). However, there was no significant difference between the autonomic nervous system and the stress resistance (p>0.05). Conclusions: As a result of this study, high-frequencytreatment using radiofrequency was effective in relieving pain because it can penetrate deeper tissues than conventional hot packs using superficial heat. In particular, it was found that the optimum effect was obtained when high frequency was applied forfive-seven minutes.

Comparative evaluation of intranasal midazolam-ketamine, dexmedetomidine-ketamine, midazolam-fentanyl, and dexmedetomidine-fentanyl combinations for procedural sedation and analgesia in pediatric dental patients: a randomized controlled trial

  • Abhilasha Agarwal;Afroz Alam Ansari;Rajendra Nath;Rakesh Kumar Chak;Rajeev Kumar Singh;Richa Khanna;Prem Raj Singh
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.23 no.2
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    • pp.69-81
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    • 2023
  • Background: In order to assess the effectiveness of various analgesio-sedative combinations for pain relief and sedation in pediatric dental patients, a thorough evaluation of clinical studies and patient outcomes is necessary. Methods: A total of 128 healthy, uncooperative pediatric dental patients were randomly allocated to receive one of the four combinations of drugs via the intranasal (IN) route: Group I received midazolam-ketamine (MK), Group II received dexmedetomidine-ketamine (DK), Group III received midazolam-fentanyl (MF), and Group IV received dexmedetomidine-fentanyl (DF) in a parallel-arm study design. The efficacy and safety of the combinations were evaluated using different parameters. Results: The onset of sedation was significantly faster in the DF group than in the DK, MF, and MK groups (P < 0.001). The depth of sedation was significantly higher in the DK and DF groups than in the MK and MF groups (P < 0.01). DK and DF produced significant intra- and postoperative analgesia when compared with combinations of MK and MF. No significant adverse events were observed for any of the combinations. Conclusions: The DK and DF groups showed potential as analgesio-sedatives in view of their anxiolytic and analgesic effects.