scholarly journals Tennis Elbow, Study Protocol for Randomized Clinical Trial: Needling With and Without Platelet-Rich Plasma After Failure of Up-to-Date Rehabilitation

2020 ◽  
Author(s):  
Adrien J-P Schwitzguebel ◽  
Mitko Bogoev ◽  
Viktor Nikolov ◽  
Freddy Ichane ◽  
Alexandre Laedermann

Abstract Background: The conservative management of lateral epicondylitis is known to be a difficult-to-treat annoying condition. A treatment with platelet-rich plasma (PRP) is often performed, but its efficacy remains controversial.Methods: This study is a single-center, randomized double-blind controlled trial, preceded by a case series.This monocentric study including 232 patients will occur in two steps. During the first step, all patients will undergo an up-to-date rehabilitation, including epicondylar stretching and strengthening, periscapular tonification, epicondylar brace or taping, and focused extracorporeal shock waves therapy. Unsatisfied patients after the first step will be allocated for the 1:1 randomized trial of second step. Stratification is planned on age and lesion pattern. The masking will be quadruple (Participant, Care Provider, Investigator & Outcome Assessor). The patients will undergo ultrasound (US)-guided needling combined with either PRP (intervention group) or saline (Control group). Outcome data will be collected at -3, 0, 3, 6, and 12 months of the intervention.The primary endpoint is the pain improvement between months 0 and 3 on a 0-10 visual analog scale (VAS) during a maximal strength isometric contraction of the extensor carpialis brevis muscle. The secondary endpoints include the proportion of patients for which the tendon needling is not necessary after rehabilitation protocol, pain changes on VAS at rest and during maximal strength isometric contraction, changes of Single Assessment Numeric Evaluation (SANE) score, changes of Patient-Rated Tennis Elbow Evaluation (PRTEE) score, changes of maximal grip strength on Jamar test, and changes of the US of the epicondylar tendons (i.e. Volume of the lesion in mm3; Doppler reaction classified at the proportion of the tendon marked with the Doppler signal; Solution of continuity in mm3; Tendon thickness in mm; Concomitant superficial lesion & volume in mm3; Pain on a 0-10 VAS scale during sonopalpation).Discussion: The study results will provide insight into the effect of PRP as adjuvant therapy to tendon fenestration, and may contribute to identify the best preceding and concomitant rehabilitation protocol.Trial registration: ClinicalTrials.gov: NCT03987256, registered 20 August 2019

2020 ◽  
Author(s):  
ADRIEN J-P SCHWITZGUEBEL ◽  
Mitko Bogoev ◽  
Viktor Nikolov ◽  
Freddy Ichane ◽  
Alexandre Laedermann

Abstract Background: The conservative management of lateral epicondylitis is known to be a difficult-to-treat annoying condition. A treatment with platelet-rich plasma (PRP) is often performed, but its efficacy remains controversial. Methods: This study is a single-center, randomized double-blind controlled trial, preceded by a case series. All the 232 planned patients of the case series will undergo an up-to-date comprehensive rehabilitation program, including focused extracorporeal shock waves therapy. This rehabilitation program is expected to have a maximum success rate 75%. It is therefore aimed to allocate a minimum of 58 patients with rehabilitation failure into the 1:1 randomized trial. Stratification is planned on age and lesion pattern. The masking will be quadruple (Participant, Care Provider, Investigator & Outcome Assessor). The patients will undergo an ultrasound (US)-guided needling combined with either PRP (intervention group) or saline (Control group). The primary endpoint will be the pain improvement from baseline (month 0) at 3 months on a 0-10 visual analog scale (VAS) during a maximal strength isometric contraction of the extensor carpialis brevis muscle. The main secondary endpoints will include the rehabilitation success rate and improvements from baseline at 3, 6 and 12 months of the following outcomes: (i) Single Assessment Numeric Evaluation (SANE) score, (ii) Patient-Rated Tennis Elbow Evaluation (PRTEE) score, (iii) maximal grip strength on Jamar test, and (iv) the ultrasonographic evaluation of the US of the epicondylar tendons.Discussion: The study results will provide insight into the effect of PRP as adjuvant therapy to tendon fenestration, and may contribute to identify the best preceding and concomitant rehabilitation protocol. Trial registration: ClinicalTrials.gov: NCT03987256, registered 20 August 2019


2020 ◽  
Vol 15 (1) ◽  
Author(s):  
A. J. Schwitzguebel ◽  
M. Bogoev ◽  
V. Nikolov ◽  
F. Ichane ◽  
A. Lädermann

Abstract Background The conservative management of lateral epicondylitis is known to be a difficult-to-treat annoying condition. A treatment with platelet-rich plasma (PRP) is often performed, but its efficacy remains controversial. Methods This study is a single-center, randomized double-blind controlled trial, preceded by a case series. All the 232 planned patients of the case series will undergo an up-to-date comprehensive rehabilitation program, including focused extracorporeal shock waves therapy. This rehabilitation program is expected to have a maximum success rate 75%. It is therefore aimed to allocate a minimum of 58 patients with rehabilitation failure into the 1:1 randomized trial. Stratification is planned on age and lesion pattern. The masking will be quadruple (Participant, Care Provider, Investigator & Outcome Assessor). The patients will undergo an ultrasound (US)-guided needling combined with either PRP (intervention group) or saline (control group). The primary endpoint will be the pain improvement from baseline (month 0) at 3 months on a 0–10 visual analog scale (VAS) during a maximal strength isometric contraction of the extensor carpialis brevis muscle. The main secondary endpoints will include the rehabilitation success rate and improvements from baseline at 3, 6, and 12 months of the following outcomes: (i) Single Assessment Numeric Evaluation (SANE) score, (ii) Patient-Rated Tennis Elbow Evaluation (PRTEE) score, (iii) maximal grip strength on Jamar test, and (iv) the ultrasonographic evaluation of the US of the epicondylar tendons. Discussion The study results will provide insight into the effect of PRP as adjuvant therapy to tendon fenestration, and may contribute to identify the best preceding and concomitant rehabilitation protocol. Trial registration ClinicalTrials.gov NCT03987256. Registered on 20 August 2019.


2021 ◽  
Vol 71 (9) ◽  
Author(s):  
Zohra Jabeen ◽  
Nighat Shah ◽  
Zaeema Ahmer ◽  
Sulhera Khan ◽  
Amir Hussain Khan ◽  
...  

Abstract Objective: The objective of this study was to compare the effectiveness of health education as an intervention to promote BSE among intervention and non-intervention group presenting in a low resource setting at North Karachi Methodology: This Quasi-experimental study was conducted from January-August 2018 in a charitable hospital in Karachi after taking ethical approval by the Institutional Review Board of Jinnah Sindh Medical University and relevant approvals from the hospital authorities. This study recruited 172 eligible women by dividing them into intervention (n=86) and control (n=86) groups from a low resource setting in Karachi. Demographic variables were collected through pretested questionnaire by interview. Intervention group then received health education regarding carcinoma of breast, importance of BSE and monthly motivation to perform BSE through cell phone. The questionnaire was again filled after 6 months of intervention. Control group was also given health education sessions upon completion of study. Results: Results revealed that both groups were similar initially. After 6 months females in intervention group showed significant (p=<0.001) improvement in knowledge and performance of BSE from 44.2% to 88.4% but there was no change in control group. Being in intervention group (RR=2.714, 95% CI= 1.760 - 4.186, p=0.001) and education (RR=0.573, 95% CI= 0.361 - 0.910, p=0.018) showed positive association with BSE performance. Upon adjusting with age, marital status, family history and education, intervention group (RR=2.570, 95% CI= 1.654 - 3.992, p= 0.001) remained significant while education (RR=1.466, 95% CI =0.910 - 2.363, p=0.116) became insignificant. Continuous...


2009 ◽  
Vol 4 (2) ◽  
pp. 161 ◽  
Author(s):  
Shandra Protzko

A Review of: Del Fiol, Guilherme, Peter J. Haug, James J. Cimino, Scott P. Narus, Chuck Norlin, and Joyce A. Mitchell. ‚Effectiveness of Topic-specific Infobuttons: A Randomized Controlled Trial.‛ Journal of the American Medical Information Association 15.6 (2008): 752-9. Objective – To assess whether infobutton links that direct users to specific content topics (‚topic links‛) are more effective in answering clinical questions than links that direct users to general overview content (‚nonspecific links‛). Design – Randomized control trial. Setting – Intermountain Healthcare, an integrated system of 21 hospitals and over 120 outpatient clinics located in Utah and southeastern Idaho. Subjects – Ninety clinicians and 3,729 infobutton sessions. Methods – To ensure comparable group composition, subjects were paired and randomly allocated to the study groups. Clinicians in the intervention group had access to topic links, while those in the control group had access to nonspecific links. All subjects at Intermountain Healthcare use a Web-based electronic medical record system (EMR) called HELP2 Clinical Desktop with integrated infobutton links. An Infobutton Manager application defines the content topics and resources; in this case, Micromedex® (Thomson Healthcare, Englewood, CO) provided access to the topic links. The medication order entry module, the most popular of the outpatient modules, was selected to test the two configurations of infobuttons. A focus group of seven HELP2 users aided the researchers in determining the most salient topics to be displayed as a part of the intervention group's user-interface. The study measured infobutton session duration, or time spent seeking information, the number of infobutton sessions conducted, and the outcome and impact of the information seeking. A post-session questionnaire displayed randomly in 30% of sessions measured outcome and impact. The study was conducted between May and November, 2007. This project was funded in part by the National Library of Medicine. Main Results – Subjects in the intervention group spent 17.4% less time seeking information than those in the control group (35.5 seconds vs. 43 seconds, p = 0.008). The intervention group used infobuttons 20.5% more often (22 sessions vs. 17.5 sessions, p = 0.21) than those in the control group, a difference that was not statistically significant. Twenty-five subjects answered the post-session survey at least once for a total of 115 (9.9%) responses out of 1,161 possible sessions. The information seeking success rate was equally high in both groups (87.2% intervention vs. 89.4% control, p = .099). Subjects reported high positive clinical impact (i.e., decision enhancement or learning) in 62% of successful sessions. Subjects conveyed a moderate or high level of frustration in 80% of responses associated with unsuccessful sessions. Conclusion – Topic links provide a slight advantage in the clinical decision-making process by reducing the amount of time spent searching. But while the session length difference between the control and intervention groups is statistically significant, it is less clear whether the difference is clinically meaningful. As previous studies have indicated, infobuttons are able to answer clinical medication questions with a high success rate. It is unclear whether topic links have a clinically significant impact, or rather, whether they are more effective than nonspecific links. The authors believe that the study results ‚should generalize to high-frequency, medication-related infobutton users in other institutions‛ (758).


2021 ◽  
Author(s):  
Kyoko Tanaka ◽  
Maoko Hayakawa ◽  
Chihiro Noda ◽  
Moemi Nakamura ◽  
Akio Nakamura ◽  
...  

Abstract Procedures and actions such as injections and immobilization cause pain and distress to children. In the pediatric field, there is a need for interventions and support to alleviate the pain and distress caused by such medical procedures. In recent years, the introduction of robots as a means of distraction has begun to be attempted. In this study, we conducted a non-randomized controlled trial to examine the effect of intervention using ‘aibo’, a dog-like robot which has artificial intelligence (AI), to promote distraction in children after vaccination. As a result, 57 children (32 in the intervention group) participated in the study. Results of a t-test with the control group showed that the intervention group using aibo had significantly less pain following the post-vaccination intervention than the control group using stuffed dog (Face Scale, t(55) = 2.582, p = .0125; Behavioral Observation Scale, t(55) = 2.772, p = .00759). The results support the hypothesis that the aibo intervention group will be less distressed and able to calm down more quickly after vaccination than the control group. Conclusion : AI-powered aibo interventions that allow for interactive interaction can be an effective distraction method during painful procedures such as vaccinations.


2020 ◽  
Vol 4 (1) ◽  
pp. 77-82
Author(s):  
Widyo Subagyo ◽  
Dyah Wahyuningsih ◽  
Mukhadiono Mukhadiono

This study aimed to determine the effect of the development of horticultural therapy to improve the social skills of mental disorders patients in the community. This research's method is quantitative research with a pre-posttest queasy experimental research design with a control group. The study results the social skills score before and after treatment in the intervention group given horticultural therapy was marked with a p-value of 0.01 (<0.05). In conclusion, there is a significant difference in the mean difference in social skills scores between the intervention and control groups.   Keywords: Mental Disorders, Social Skills, Horticultural Therapy


2020 ◽  
Vol 4 (1) ◽  
pp. 20-30
Author(s):  
Candra Saputra ◽  
Yulastri Arif ◽  
Fitra Yeni

This study aimed to determine the effectiveness of ANNISA development on nurses' knowledge of nursing documentation. This method uses quantitative research with a quasi-experimental design and a time series approach non-equivocal control group design. The study results were there were differences in the measurement of nurses' knowledge about nursing documentation in the intervention group before the intervention by measuring posttest-1 with p-value = 0.000. There were differences in nurses' experience about nursing documentation between the intervention group and the control group in the posttest-1 and posttest-2 measurements after the intervention using ANNISA with p-value = 0,000. There was an increase in differences in nurses' knowledge about nursing documentation from the pretest, posttest-1, and posttest-2 measurements after using ANNISA in the intervention group and the control group with p-value = 0.000. In conclusion, ANNISA development affects increasing the knowledge of nurses about nursing documentation   Keywords: ANNISA, Nursing Documentation, Knowledge


2021 ◽  
Vol 11 (7) ◽  
pp. 1372-1376
Author(s):  
Wei Wang ◽  
Weiwei Ma ◽  
Xu Li ◽  
Yihui Huang ◽  
Xinyu Cao

Our study aims to elucidate the role of platelet-rich plasma (PRP) in rats chondrocytes inflammation and mechanism. PRP was obtained from 8 weeks old rats. Then, the knee joint of bilateral hind limbs was dissected and articular chondrocytes were obtained in super-clean table after dislocation and identified at the second generation during culture and passage. Chondrocytes were divided into control group 1 (addition of saline), control group 2 (IWP-2, Wnt/β-catenin axis inhibitor) and experimental group (PRP) followed by analysis of mRNA levels of glycogen synthase kinase-3 (GSK-3β), low-density lipoprotein receptor-associated protein 5 (LRP5), Wnt1 and β-catenin by RT-PCR, IL-1 and TNF-α after 1 week by ELISA. The second generation articular chondrocytes presented polygonal or triangular cell morphology, positive for collagen II and toluidine blue staining. PRP addition significantly reduced GSK-3β and LRP5 mRNA level, and increased β-catenin and Wnt1 mRNA levels in chondrocytes. Meanwhile, it suppressed IL-1 and TNF-α secretion and Wnt protein production inhibitor 2. PRP might suppresses inflammatory factors production of rat articular chondrocytes through inhibiting Wnt/β-catenin axis.


2021 ◽  
Vol 4 (2) ◽  
pp. 47-53
Author(s):  
Sofia Tsatsou-Nikolouli ◽  
Stavroula Mavrogeni

Education is not only about the transferring of knowledge, but also about the cultivation of strong social and emotional skills, which are necessary for the strengthening of the social competence of students, their positive self-perception and their success in school. Empathy, which refers to the ability to recognize another person‟s emotional state is one of the basic skills of the 21st century, which helps all students grow up to become active and critically aware citizens. The research/intervention program "Creative Writing and Social Learning Skills", implemented by students of the 5th and 6th grade of elementary schools in Thessaloniki, Greece, explores the enhancement of empathy, through the use of creative writing as an educational tool. Activities used were based on literary texts from Balkan countries and countries of Eastern and Southeastern Europe. The research sample consisted of 573 students, who were divided into the Intervention Group, that implemented the program, and the Control Group, that attended its regular curriculum. The analysis of the level of skills in children, and especially the level of empathy, which is of concern to us in the present study, was carried out using a structured improvised questionnaire, the alpha Cronbach coefficients where of range at very high levels. Study results showed that the Intervention Group exhibited statistically greater improvement in the assessment of empathy compared to the Control Group.


Author(s):  
Mahmoud Ibrahim Kandil ◽  
Abdel-Salam Abdel-Aleem Ahmed ◽  
Rasha Shaker Eldesouky ◽  
Sherif Eltregy

Abstract Purpose The purpose of this study aimed to evaluate the efficacy of local injection of allogeneic platelet-derived growth factors in treatment of patients with tennis elbow. Patients and methods This study included 120 tennis elbow patients randomly divided into two groups. The patients were locally injected with allogeneic growth factors (treatment group) or with normal saline (control group). The outcomes were assessed using Patient-Related Tennis Elbow Evaluation (PRTEE) and quick Disabilities of the Arm, Shoulder and Hand (qDASH) scales. The clinical outcomes were accordingly classified as excellent, good and poor. The patient’s satisfaction and adverse effects were also recorded. Results There was no statistically significant difference between the two groups regarding the age, gender, dominant arm or the pre-injection scores. At three month follow-up, the reductions in the mean PRTEE and qDASH scores were 88.7% and 70.6% in the treatment group versus 21.8% and 14.9% in the control group, respectively. At the last follow-up, the outcomes in the treatment group were excellent in 85% of patients and good in 15%, versus 8% and 32% in the control group. Overall, 95% were satisfied in the treatment group compared to 25% in control group. Forty patients in the treatment group experienced mild transient post-injection pain. Conclusion This study strongly suggests that local injection of allogeneic platelet-derived growth factors could be a promising safe treatment option for tennis elbow with significant pain relief, functional improvement and patient’s satisfaction. Yet, additional larger studies are needed to assess the durability of these outcomes.


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