scholarly journals Tennis Elbow, study protocol for a 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. 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.


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


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):  
Diana VRABIE ◽  
Beatrice-Aurelia ABALAȘEI ◽  
George-Sebastian IACOB

Although there are multiple published reviews about the effects of the most common techniques, such as stretching or the use of foam roller on the range of motion (Behm et al., 2016; Wilke et al., 2020) or performance parameters (Behm & Wilke, 2019; Konrad et al., 2021), there is no analysis on the effects of medical flossing. To date, two reviews have been publishedabout effectiveness of using ankle flossing to improve dorsiflexion amplitude or jump performance (Pisz et al., 2020; Kielur & Powden, 2020). This study aimed to investigate the effectiveness of medical flossing added to routine treatment in patients with epicondylitis, compared to conventional physiotherapy treatment. The study included 6 subjects who showed localized pain in the area of the lateral epicondyle exacerbated with the Cozen test. The other criteria for selecting patients were the duration of the symptoms, less than 3 months from the onset of the disease and pain intensity more than 5 on the Visual Analog scale.To monitor the evolution of the subjects involved, we used a visual analog pain scale to assess the intensity of pain at different times during the application of therapy, before and after the end of the treatment. Another tool used to measure the degree of pain and dysfunction was the PRTEE Questionnaire (Patient-Rated Tennis Elbow Evaluation). The rehabilitation program took place between August and September 2021, for 30 days, with afrequency of 3 times per week. 6 patients with lateral epicondylitis were included and medical flossing was used only in the case of 3 patients at each therapy session. The differences between groups at the time of the initial assessment, in terms of pain intensity were statistically insignificant (p=0.288, p>0.05). The results obtained in terms of decreasing pain were in favor of the use of medical flossing as an adjuvant method in specific pain existing in lateral epicondylitis. Although in both groups there was a decrease in pain after 4 weeks of treatment, the intervention group recorded significant reduced values compared to the control group (p=0.024; p<0.05). Regarding PRTEE Functional Score, at the final assesment there was a decrease in both groups, which means the functional condition of the patients has improved.


2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
LE Estrada Martinez ◽  
JA Lara Vargas ◽  
JA Pineda Juarez ◽  
JD Morales Portano ◽  
JB Gomez Alvarez ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Introduction  Due to the increase in global prevalence of degenerative valve disease, aortic stenosis (AS) has played a preponderant role in the cardiovascular scenario, especially in patients undergoing transcatheter aortic valve replacement (TAVR). An alternative management for this patients are the cardiac rehabilitation programs (CRP); however, their effect has not been completely understood, both in exercise capacity and quality of life, but neither in the improvement of cardiopulmonary performance and other cardiovascular outcomes.  Purpose: To evaluate the effect of the CRP on exercise tolerance and cardiopulmonary performance in patients with AS undergoing TAVR.  Methods: A cohort study was conducted including 26 patients with AS undergoing TAVR and divided into an intervention group who performed a 4-week supervised training program in the Cardiac Rehabilitation Service and a control group to whom instructions and recommendations to performed unsupervised exercise at home were given. Demographic and clinical data (VO2Max, METS12, oxygen pulse, heart rate, double product, left ventricular ejection fraction, body mass index) were collected at baseline and after a 4-week follow-up. Results: 15 patients were included in the intervention group and 11 patients in the control group. There were no baseline significant differences between groups. After the intervention, significant differences were observed in the METS 12 final gain variable between the control and intervention group (4.55 vs 3.1 p = 0.01). Intergroup analysis showed significant differences (percentage changes) in the intervention group with an increase of METS12 (67.4%, p = 0.001), oxygen pulse (18.21%, p = 0.01), final METS (39.47% p = 0.001) and a decrease in VO2 recovery time (-12.5%, p = 0.05), in the ergometric performance index by heart rate (-38.17%, p = 0.001) and by double product (-38.1%, p = 0.001). Conclusions  A 4-week cardiac rehabilitation program is effective to improve exercise tolerance and cardiopulmonary response in patients with AS undergoing TAVR; improvement was statistically significant in METS12, oxygen pulse, VO2 recovery time, METS-load and ergometric performance index for heart rate and double product. METS12 final gain was statistically significant in intervention group in comparison with the control group. Abstract Figure. Control vs Intervention Group (METS12)


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...


2021 ◽  
Author(s):  
Ahmed Negm ◽  
Milad Yavarai ◽  
Gian Jhangri ◽  
Robert Haennel ◽  
Allyson Jones

Abstract BackgroundThe increase rate seen in Total Hip Arthroplasty (THA) for younger patients has implications for future rehabilitation demands for primary and revision THA surgery. This study aims to determine the impact of a 6-week post-operative rehabilitation program designed for THA patients ≤ 60 years on physical activity (PA) and function compared to age- and a sex-matched control group received usual postoperative care at 12-week post-THA. MethodsIn this quasi-experimental study, a cohort of THA candidates was recruited during their 6-week postoperative visit to their surgeons. The out-patient rehabilitation program consisted of 12 structured exercise classes (2 hrs/class) over 6 weeks. Physical activity was assessed using Sense Wear Pro ArmbandTM [SWA]. Participants completed the Hip Osteoarthritis Outcome Score (HOOS), and THA satisfaction questionnaire before and immediately after the intervention. ResultsThe intervention group took significantly more steps/day at the follow-up compared to baseline. The intervention group had a higher mean change in the number of weekly PA bouts than the control group. Within the intervention groups, all HOOS subscales were significantly higher at the follow-up compared to baseline. ConclusionThe augmented rehabilitation program may have immediate effects on pain relief and symptom reduction for patients (≤60 years) following THA.


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


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