Effect of tunneled and nontunneled peripherally inserted central catheter placement: A randomized controlled trial

Purpose: To compare the effect of tunneled and nontunneled peripherally inserted central catheter placement under B-mode ultrasound. Methods: A single center, randomized, controlled, nonblinded, prospective trial was conducted in Guangzhou, China, between July 2018 and May 2019. A total of 174 participants were randomized to the experimental group (tunneled peripherally inserted central catheter) or the control group (nontunneled peripherally inserted central catheter) and were followed until extubation. Basic characteristics, peripherally inserted central catheter characteristics, the incidence of complications, and the costs of peripherally inserted central catheter placement and maintenance were collected. Data were analyzed by intention-to-treat. Results: A total of 168 of the participants had successful peripherally inserted central catheter placements (85/87, 97.7% in the experimental group and 83/87, 95.4% in the control group, P = 0.682). Compared to the control group, the experimental group had a lower incidence of complications during the placement (18.4% vs 32.2%, P = 0.036), a lower incidence of wound oozing (27.6% vs 57.5%, P < 0.001), a lower incidence of medical adhesive–related skin injury (9.2% vs 25.3%, P = 0.005), a lower incidence of venous thrombosis (1.1% vs 9.2%, P = 0.034), a lower incidence of catheter dislodgement (1.1% vs 9.2%, P = 0.034), and lower costs of peripherally inserted central catheter maintenance at 1, 2, and 3 months ( P < 0.05). Conclusion: Tunneled peripherally inserted central catheter may be recommended for good effectiveness.

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

Bulletin of Faculty of Physical Therapy ◽

10.1186/s43161-021-00030-2 ◽

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).

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The effects of transcutaneous electrical nerve stimulation during the first stage of labor: a randomized controlled trial

BMC Pregnancy and Childbirth ◽

10.1186/s12884-021-03625-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Anne Njogu ◽

Si Qin ◽

Yujie Chen ◽

Lizhen Hu ◽

Yang Luo

Keyword(s):

Transcutaneous Electrical Nerve Stimulation ◽

Controlled Trial ◽

Labor Pain ◽

Control Group ◽

Electrical Nerve Stimulation ◽

Randomized Controlled ◽

Active Labor ◽

Vas Scores ◽

Experimental Group ◽

First Stage Of Labor

Abstract Background Labor pain during childbirth can have devastating effects on the progress of labor, mother, and fetus. Consequently, the management of labor pain is crucial for the well-being of the mother and fetus. Transcutaneous electrical nerve stimulation (TENS) is a non -pharmacological analgesic technique. It uses a low-voltage electrical current to activate descending inhibitory systems in the central nervous system to relieve pain. This study aimed to determine the effects of TENS therapy in the first stage of labor. Methods In this single-blind randomized controlled trial, we screened low-risk pregnant women who anticipated spontaneous vaginal delivery. Women were assigned (1:1) to either the experimental group (received TENS therapy in the first stage of labor) or the control group (received routine obstetric care). The women, midwives, and researchers working in the gynecology and obstetric department were aware of the treatment group, but statisticians analysis the data were blinded. The primary outcome was labor pain intensity, assessed by visual analog scale (VAS) immediately after the randomization, at 30, 60, and 120 min after TENS therapy, and 2–24 h post-delivery. We used SPSS 21.0 software in data analysis. An independent sample t-test compared the mean VAS scores and labor duration between groups. A Chi-square test was employed to compare categorical variables between the groups. A significant level of ≤0.05 was statistically significant. Results A total of 326 pregnant women were eligible: experimental group (n = 161) and control group (n = 165). The experimental group had statistically significantly lower mean VAS scores at a different time (30, 60, and 120 min post-intervention and 2–24 h post-delivery) than the control group (p < 0.001). The experimental group demonstrated a statistically significant shorter duration of the active labor phase than the control group (p < 0.001). Conclusion This study indicates that TENS can be used as a non-pharmacological therapy to reduce pain and shorten the active labor phase. Trial registration ISRCTN registry, ISRCTN23857995. Registered on 11/12/2020, ‘retrospectively registered.

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Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-pelvic Stability and Adductor Strength in Women Soccer Players. A Randomized Controlled Study.

10.21203/rs.3.rs-108504/v1 ◽

2020 ◽

Author(s):

Héctor Guerrero-Tapia ◽

Rodrigo Martín-Baeza ◽

Rubén Cuesta-Barriuso

Keyword(s):

Repeated Measures ◽

Controlled Trial ◽

Gluteus Medius ◽

Soccer Players ◽

Controlled Study ◽

Control Group ◽

Extrinsic Factors ◽

Randomized Controlled ◽

Limb Injuries ◽

Experimental Group

Abstract Background: Abdominal and lumbo-pelvic stability alterations may origin lower limb injuries, such as for example adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: This randomized controlled trial conducted over an 8-week period included 25 female footballers randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). The exercise protocol in common for both groups included three exercises: Plank, Lateral plank and Bird dog. Specific exercises for the gluteus medius were: Pelvic drop and Stabilization of the gluteus medius in knee valgus. Outcome measures were lumbo-pelvic stability and adductor strength.Results. Lumbo-pelvic stability after surgery was higher in the control group (MD: 4.84 vs MD: 9.58; p < .01) with differences in the analysis of repeated measures (p<.001), but not in group interaction (p =.26). Changes were found in adductor strength in the experimental group (MD: -2.48; p<.001 in the left adductor; MD: -1.48; p<.01 in right adductor) and control group (MD: -1.68; p<.001 in the left adductor; MD: -2.05; p<.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p<.001) and right (p<.001) adductor strength.Conclusions. An abdominal and gluteal training protocol shows no advantage over a protocol of abdominal training alone for lumbo-pelvic stability and adductor strength and flexibility, while improvements are maintained at four weeks follow-up. Trial Registration Number: NCT03617887.

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Cluster Symptoms Reduction via Telephone-Based Intervention in Thai Breast Cancer Patients Undergoing 4-Cycle Adjuvant Chemotherapy: A Randomized-Controlled Trial

Journal of the Medical Association of Thailand ◽

10.35755/jmedassocthai.2021.06.12341 ◽

2021 ◽

Vol 104 (6) ◽

pp. 887-894

Keyword(s):

Breast Cancer ◽

Randomized Controlled Trial ◽

Adjuvant Chemotherapy ◽

Energy Conservation ◽

Cancer Patients ◽

Controlled Trial ◽

Control Group ◽

Breast Cancer Patients ◽

Randomized Controlled ◽

Experimental Group

Background: Cluster symptoms are a common occurrence in breast cancer patients undergoing chemotherapy. The telephone is a well-recognized, convenient device for reaching out to patients for monitoring and managing their symptoms in an efficient, prompt, and appropriate manner. Objective: To investigate the efficacy of telephone-based intervention to achieve energy conservation among breast cancer patients with the aim of alleviating fatigue, pain, sleep disturbance, and depression. Materials and Methods: The present study was a two-armed, randomized control trial conducted in the university hospital between March and September 2019. Seventy-four breast cancer patients, receiving four courses of adjuvant chemotherapy, were randomly recruited and assigned into the experimental group and the control group. One face-to-face intervention interview for energy conservation was conducted, followed by 20-minutes telephone brief counselling and assessment sessions, scheduled on day 1, 2, 7, and 14. Results: The scores for symptoms of median fatigue and pain in the experimental group were shown to be significantly reduced at the end of the study as compared to those scores within the control group (p<0.05). Similarly, scores for median sleep time and depression were greater at the end of cycle 1 and highest in cycle 2 (p<0.05, 0.001, respectively). Physical activity levels were also higher in the experimental group than in the control group in every cycle, with a statistical significance (p<0.001). Conclusion: The present study intervention demonstrated an effectiveness for the reduction of cluster symptoms. Further studies would be needed in a larger population scale in the customary, randomized controlled trial manner. Keywords: Cancer; Energy conservation; Fatigue; Pain; Sleep; Telephone

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Testing the Effectiveness of a Strengths-Based Intervention Targeting All 24 Strengths: Results From a Randomized Controlled Trial

Psychological Reports ◽

10.1177/0033294120937441 ◽

2020 ◽

pp. 003329412093744

Author(s):

Lobna Chérif ◽

Valerie M. Wood ◽

Christian Watier

Keyword(s):

Randomized Controlled Trial ◽

Character Strengths ◽

Controlled Trial ◽

Control Group ◽

Strength Development ◽

Character Strength ◽

Significant Group ◽

Randomized Controlled ◽

Time Interaction ◽

Experimental Group

This study assessed the effectiveness of a strengths-based randomized controlled trial focused on fostering all 24 character strengths in a group of 75 participants from a University in Tunisia. Participants randomly assigned to the challenge condition (n = 40) received an email each day for 24 days, that highlighted a particular strength of the day including why the strength is valuable, how to implement the strength behaviourally, and a motto related to that strength. Those in the control condition (n = 35) simply received emails containing the motto for each strength daily for 24 days. We assessed all participants’ levels of happiness before the experiment (T0), the day following the experiment (T1), and one-month following the experiment (T2). Results from a 2 (group) X 3 (time) split plot ANOVA revealed a significant group-by-time interaction, such that at T2 the experimental group had greater happiness scores than the control group. These findings provide some evidence that even “minimalist” interventions (involving the receipt of emails encouraging character-strength development), might be effective for promoting gains in happiness even one month after the intervention.

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Acceptance and commitment therapy for the treatment of depression in persons with physical disability: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215520923135 ◽

2020 ◽

Vol 34 (7) ◽

pp. 938-947 ◽

Cited By ~ 1

Author(s):

Mehdi Zemestani ◽

Sharmin Mozaffari

Keyword(s):

Emotion Regulation ◽

Depressive Symptoms ◽

Controlled Trial ◽

Psychological Flexibility ◽

Well Being ◽

Control Group ◽

Psychological Well Being ◽

Randomized Controlled ◽

Acceptance And Commitment ◽

Experimental Group

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group ( n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group ( n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants’ depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.

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Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17072465 ◽

2020 ◽

Vol 17 (7) ◽

pp. 2465

Author(s):

Alfonso Javier Ibáñez-Vera ◽

Jerónimo Carmelo García-Romero ◽

José Ramón Alvero-Cruz ◽

Rafael Lomas-Vega

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Sham Group ◽

Controlled Trial ◽

Depression Scale ◽

Physical Factor ◽

Control Group ◽

Local Pain ◽

Randomized Controlled ◽

Experimental Group

Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study’s goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 ± 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy (n = 22); or a control group (n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R2 = 0.46), total ICAF (R2 = 0.42) and ICAF physical factor scores (R2 = 0.38). Significant mean differences were found for the local pain (p = 0.025) and ICAF physical factor (p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.

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A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial

Trials ◽

10.1186/s13063-020-04699-z ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Nicole C. Gavin ◽

Tricia M. Kleidon ◽

Emily Larsen ◽

Catherine O’Brien ◽

Amanda Ullman ◽

...

Keyword(s):

Standard Care ◽

Dwell Time ◽

Controlled Trial ◽

Intervention Group ◽

Trial Registration ◽

Care Group ◽

Control Group ◽

Peripherally Inserted Central Catheter ◽

Central Catheter ◽

Efficacy Trial

Abstract Background To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC. Methods This pilot randomised controlled trial (RCT) was conducted between May 2017 and February 2018. Adult participants (n = 111) were assigned to hydrophobic polyurethane PICC with proximal valve (intervention) or a polyurethane PICC with external clamp (standard care). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were central line-associated bloodstream infection, local infection, occlusion, thrombosis, fracture and dislodgement, phlebitis, local or systemic allergic reaction, and PICC dwell time. Results All feasibility outcomes were achieved, apart from eligibility criteria. In total, 338 patients were screened, 138 were eligible (41%), and of these 111 were randomised (80%). Patients received the allocated PICC in 106 (95%) insertions. No patients withdrew from the study and there was no missing data. PICC failure was 24% (13/55) in the intervention group and 22% (12/55) in the standard care group (p = 0.820). PICC failure per 1000 PICC days was 16.3 in the intervention group and 18.4 in the control group (p = 0.755). The average dwell time was 12 days in the intervention and 8 days in the control group. Conclusions This study demonstrates the feasibility of an efficacy trial of PICC materials in an adult population, once adjustments were made to include not only in-patients, but also patients being discharged to the Hospital in the Home service. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12616001578493. Prospectively registered on 16 November 2016. The trial protocol was published a priori (Kleidon et al., Vasc Access 3:15–21, 2017).

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Effectiveness of Hydrogalvanic Bath on Improving Pain, Disability, and Quality of Life in Individuals with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/7974816 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Mastour Saeed Alshahrani ◽

Jaya Shanker Tedla ◽

Ravi Shankar Reddy ◽

Faisal Asiri

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Pain Disability ◽

Sf 36 ◽

Neck Disability ◽

Experimental Group

Background. Neck pain is one of the world’s leading factors in years lived with disability. Ambiguity in the effect of electrotherapy modalities for the treatment of chronic nonspecific neck pains (CNSNP) needs to be examined further. This study sought to elucidate the effectiveness of hydrogalvanic bath on improving pain, disability, and quality of life among individuals with CNSNP. Methods. Thirty-four individuals with a diagnosis of CNSNP were selected through convenient sampling and randomly divided into two groups by block randomization. The control group treatment underwent low Transcutaneous Electrical Nerve Stimulation (TENS) and exercise, and the experimental group was subjected to hydrogalvanic bath therapy (HGBT) and exercise. Individuals were evaluated for pain using a visual analog scale (VAS), disability with the Neck Disability Index (NDI), and quality of life with Short Form-36 (SF-36). These measures were applied at baseline and after 12 weeks of treatment. Results. The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups. We found that all the three variables showed significant differences between the two time points with p < 0.05 in both the groups but the experimental group improvements were more significant than the control group with p < 0.05 . Conclusion. Twelve weeks of low TENS or HGBT along with exercises can decrease pain and neck disability and increase the quality of life in individuals with CNSNP. However, HGBT along with exercise has superior effects relative to low TENS along with exercise. This randomized controlled trial was registered in the International Standard Randomized Controlled Trials Number-ISRCTN29695190 and registered on 05/02/2020. This study is a retrospective registration.

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Effects of an Interactive Computer Game Exercise Regimen on Balance Impairment in Frail Community-Dwelling Older Adults: A Randomized Controlled Trial

Physical Therapy ◽

10.2522/ptj.20090205 ◽

2011 ◽

Vol 91 (10) ◽

pp. 1449-1462 ◽

Cited By ~ 84

Author(s):

Tony Szturm ◽

Aimee L. Betker ◽

Zahra Moussavi ◽

Ankur Desai ◽

Valerie Goodman

Keyword(s):

Randomized Controlled Trial ◽

Video Game ◽

Dynamic Balance ◽

Controlled Trial ◽

Community Dwelling ◽

Control Group ◽

Day Hospital ◽

Randomized Controlled ◽

Balance Exercises ◽

Experimental Group

Background Due to the many problems associated with reduced balance and mobility, providing an effective and engaging rehabilitation regimen is essential to progress recovery from impairments and to help prevent further degradation of motor skills. Objectives The purpose of this study was to examine the feasibility and benefits of physical therapy based on a task-oriented approach delivered via an engaging, interactive video game paradigm. The intervention focused on performing targeted dynamic tasks, which included reactive balance controls and environmental interaction. Design This study was a randomized controlled trial. Setting The study was conducted in a geriatric day hospital. Participants Thirty community-dwelling and ambulatory older adults attending the day hospital for treatment of balance and mobility limitations participated in the study. Interventions Participants were randomly assigned to either a control group or an experimental group. The control group received the typical rehabilitation program consisting of strengthening and balance exercises provided at the day hospital. The experimental group received a program of dynamic balance exercises coupled with video game play, using a center-of-pressure position signal as the computer mouse. The tasks were performed while standing on a fixed floor surface, with progression to a compliant sponge pad. Each group received 16 sessions, scheduled 2 per week, with each session lasting 45 minutes. Measurements Data for the following measures were obtained before and after treatment: Berg Balance Scale, Timed “Up & Go” Test, Activities-specific Balance Confidence Scale, modified Clinical Test of Sensory Interaction and Balance, and spatiotemporal gait variables assessed in an instrumented carpet system test. Results Findings demonstrated significant improvements in posttreatment balance performance scores for both groups, and change scores were significantly greater in the experimental group compared with the control group. No significant treatment effect was observed in either group for the Timed “Up & Go” Test or spatiotemporal gait variables. Limitations The sample size was small, and there were group differences at baseline in some performance measures. Conclusion Dynamic balance exercises on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based exercise. This coupling, in turn, resulted in a greater improvement in dynamic standing balance control compared with the typical exercise program. However, there was no transfer of effect to gait function.

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