scholarly journals The Effects of Mycophenolate on the Formation of Granulation Tissue Post-operatively in Canine Tracheal Stent Patients (2014–2020)

2021 ◽  
Vol 8 ◽  
Author(s):  
Kevin F. Barber ◽  
Catherine A. Loughin ◽  
Dominic J. Marino ◽  
Martin Lesser
Keyword(s):  
Mycophenolate Mofetil ◽  
Granulation Tissue ◽  
Control Group ◽  
Tracheal Lumen ◽  
Loss To Follow Up ◽  
Treatment Groups ◽  
Tracheal Stent ◽  
Significant Difference ◽  
Tracheal Collapse

Objectives: To determine if mycophenolate mofetil reduces the incidence and severity of granulation tissue in-growth in canine tracheal stent patients.Study design: Randomized clinical trial.Animals: 111 dogs from the hospital population.Methods: Client-owned dogs that received an endoluminal self-expanding tracheal stent for canine tracheal collapse between 2014 and 2020 were randomly assigned into one of two treatment groups. Control group medication protocol consisted of prednisone 0.5 mg/kg PO BID/SID/EOD × 30 days, hydrocodone 0.25 mg/kg PO TID × 30 days, and cefovecin 8 mg/kg SQ post-placement. Mycophenolate group medication protocol was identical to the control group medication protocol with the addition of mycophenolate mofetil 10 mg/kg PO BID × 30 days, SID for life. Recheck tracheoscopy was performed at 1, 3, and 6 months post-stent placement. Presence and severity of granulation tissue were determined by tracheoscopy and were recorded as a percentage of tracheal lumen obstruction by blinded evaluators (none present, <25%, >25–50%, and >50%).Results: At none of the three time points was there a statistically significant difference in grade between controls and those receiving mycophenolate (p = 0.467, p = 0.330, and p = 0.410).Conclusions and Clinical Significance: Our results suggest that mycophenolate can be safely given to these patients but do not support that its administration will reduce the incidence and severity of granulation tissue. Although a difference was observed in the severity of granulation tissue between the two groups, loss to follow-up may have influenced conclusions. A larger study would be warranted to further evaluate the effect of mycophenolate on the development of granulation tissue.

Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

2021 ◽  
pp. 112070002110057
Author(s):  
Niels H Bech ◽  
Inger N Sierevelt ◽  
Sheryl de Waard ◽  
Boudijn S H Joling ◽  
Gino M M J Kerkhoffs ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Treatment Groups ◽  
Significant Difference ◽  
Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p  > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

scholarly journals Quantifying Withdrawal of Consent, Loss to Follow-Up, Early Drug Discontinuation, and Censoring in Oncology Trials

2021 ◽  
pp. 1-8
Author(s):  
Brooke E. Wilson ◽  
Michelle B. Nadler ◽  
Alexandra Desnoyers ◽  
Eitan Amir
Keyword(s):  
Censored Data ◽  
Control Group ◽  
Drug Discontinuation ◽  
Open Label ◽  
Loss To Follow Up ◽  
Significant Difference ◽  
And Control ◽  
Experimental Group ◽  
Early Drug

Background: Censoring due to early drug discontinuation (EDD) or withdrawal of consent or loss to follow-up (WCLFU) can result in postrandomization bias. In oncology, censoring rules vary with no defined standards. In this study, we sought to describe the planned handling and transparency of censoring data in oncology trials supporting FDA approval and to compare EDD and WCLFU in experimental and control arms. Methods: We searched FDA archives to identify solid tumor drug approvals and their associated trials between 2015 and 2019, and extracted the planned handling and reporting of censored data. We compared the proportion of WCLFU and EDD between the experimental and control arms by using generalized estimating equations, and performed logistic regression to identify trial characteristics associated with WCLFU occurring more frequently in the control group. Results: Censoring rules were defined adequately in 48 (59%) of 81 included studies. Only 14 (17%) reported proportions of censored participants clearly. The proportion of WCLFU was higher in the control group than in the experimental group (mean, 3.9% vs 2.5%; β-coefficient, −2.2; 95% CI, −3.1 to −1.3; P<.001). EDD was numerically higher in the experimental arm in 61% of studies, but there was no statistically significant difference in the proportion of EDD between the experimental and control groups (mean, 21.6% vs 19.9%, respectively; β-coefficient, 0.27; 95% CI, −0.32 to 0.87; P=.37). The proportion of EDD due to adverse effects (AEs) was higher in the experimental group (mean, 13.2% vs 8.5%; β-coefficient, 1.5; 95% CI, 0.57–2.45; P=.002). WCLFU was higher in the control group in studies with an active control group (odds ratio [OR], 10.1; P<.001) and in open label studies (OR, 3.00; P=.08). Conclusions: There are significant differences in WCLFU and EDD for AEs between the experimental and control arms in oncology trials. This may introduce postrandomization bias. Trials should improve the reporting and handling of censored data so that clinicians and patients are fully informed regarding the expected benefits of a treatment.

scholarly journals Effectiveness of Text Messaging as an Incentive to Maintain Physical Activity after Cardiac Rehabilitation: A Randomized Controlled Pilot Study

2021 ◽  
Vol 18 (12) ◽  
pp. 6645
Author(s):  
Giulia Foccardi ◽  
Marco Vecchiato ◽  
Daniel Neunhaeuserer ◽  
Michele Mezzaro ◽  
Giulia Quinto ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cardiac Rehabilitation ◽  
Exercise Testing ◽  
Text Messages ◽  
Control Group ◽  
Stand Test ◽  
Randomized Controlled ◽  
Sit To Stand ◽  
Significant Difference

Although the efficacy of cardiac rehabilitation (CR) is proven, the need to improve patients’ adherence has emerged. There are only a few studies that have investigated the effect of sending text messages after a CR period to stimulate subjects’ ongoing engagement in regular physical activity (PA). A randomized controlled pilot trial was conducted after CR, sending a daily PA text message reminder to an intervention group (IG), which was compared with a usual care control group (CG) during three months of follow-up. Thirty-two subjects were assessed pre- and post-study intervention with GPAQ, submaximal iso-watt exercise testing, a 30 s sit-to-stand test, a bilateral arm curl test, and a final survey on a seven-point Likert scale. A statistically significant difference in the increase of moderate PA time (Δ 244.7 (95% CI 189.1, 300.4) minutes, p < 0.001) and in the reduction of sedentary behavior time (Δ −77.5 (95% CI 104.9, −50.1) minutes, p = 0.004) was shown when the IG was compared with the CG. This was associated with an improvement in heart rate, blood pressure, and patients’ Borg rating on the category ratio scale 10 (CR10) in iso-watt exercise testing (all p < 0.05). Furthermore, only the IG did not show a worsening of the strength parameters in the follow-up leading to a change of the 30 s sit-to-stand test with a difference of +2.2 (95% CI 1.23, 3.17) repetitions compared to CG (p = 0.03). The telemedical intervention has been appreciated by the IG, whose willingness to continue with regular PA emerged to be superior compared to the CG. Text messages are an effective and inexpensive adjuvant after phase 2 CR that improves adherence to regular PA. Further studies are needed to confirm these results in a larger patient population and in the long term.

scholarly journals Association of biological antirheumatic therapy with risk for type 2 diabetes: a retrospective cohort study in incident rheumatoid arthritis

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e042246
Author(s):  
Sanjoy K Paul ◽  
Olga Montvida ◽  
Jennie H Best ◽  
Sara Gale ◽  
Attila Pethö-Schramm ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Type 2 Diabetes ◽  
T Cell ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Therapy ◽  
Treatment Groups ◽  
Significant Difference ◽  
Necrosis Factor

ObjectiveTo explore possible associations of treatment with biological disease-modifying antirheumatic drugs (bDMARDs), including T-cell-based and interleukin-6 inhibition (IL-6i)-based therapies, and the risk for type 2 diabetes mellitus (T2DM) in patients with rheumatoid arthritis (RA).Study design, setting and participantsFive treatment groups were selected from a United States Electronic Medical Records database of 283 756 patients with RA (mean follow-up, 5 years): never received bDMARD (No bDMARD, n=125 337), tumour necrosis factor inhibitors (TNFi, n=34 873), IL-6i (n=1884), T-cell inhibitors (n=5935) and IL-6i+T cell inhibitor abatacept (n=1213). Probability and risk for T2DM were estimated with adjustment for relevant confounders.ResultsIn the cohort of 169 242 patients with a mean 4.5 years of follow-up and a mean 641 200 person years of follow-up, the adjusted probability of developing T2DM was significantly lower in the IL-6i (probability, 1%; 95% CI 0.6 to 2.0), T-cell inhibitor (probability, 3%; 95% CI 2.3 to 3.3) and IL-6i+T cell inhibitor (probability, 2%; 95% CI 0.1 to 2.9) groups than in the No bDMARD (probability, 5%; 95% CI 4.6 to 4.9) and TNFi (probability, 4%; 95% CI 3.7 to 4.7) groups. Compared with No bDMARD, the IL-6i and IL-6i+T cell inhibitor groups had 37% (95% CI of HR 0.42 to 0.96) and 34% (95% CI of HR 0.46 to 0.93) significantly lower risk for T2DM, respectively; there was no significant difference in risk in the TNFi (HR 0.99; 95% CI 0.93 to 1.06) and T-cell inhibitor (HR 0.96; 95% CI 0.82 to 1.12) groups.ConclusionsTreatment with IL-6i, with or without T-cell inhibitors, was associated with reduced risk for T2DM compared with TNFi or No bDMARDs; a less pronounced association was observed for the T-cell inhibitor abatacept.

scholarly journals Impact of failed ab-interno trabeculectomy (trabectome) on subsequent XEN45 gel stent implantation in pseudophakic eyes

2021 ◽  
Author(s):  
D. Kiessling ◽  
C. Rennings ◽  
M. Hild ◽  
A. Lappas ◽  
T. S. Dietlein ◽  
...  
Keyword(s):  
Stent Implantation ◽  
Open Angle Glaucoma ◽  
Control Group ◽  
Repeat Surgery ◽  
Medication Score ◽  
Significant Difference ◽  
Ab Interno Trabeculectomy ◽  
The Impact ◽  
Ab Interno

Abstract Purpose To determine the impact of failed ab-interno trabeculectomy on the postoperative outcome of subsequent XEN45 gel stent (Allergan, CA, USA) implantation in pseudophakic eyes. Methods In this retrospective single-center study, we included 60 pseudophakic eyes from 60 participants who underwent XEN45 gel stent implantation. Thirty eyes each underwent primary stent implantation (control group) or had previously undergone a failed ab-interno trabeculectomy (trabectome group). The groups were matched at a 1:1 ratio based on the following criteria: preoperative and maximum Intraocular pressure (IOP), preoperative medication score, cup/disk-ratio, follow-up time, best-corrected visual acuity at baseline, age, and the proportion of patients classified as primary open angle glaucoma or exfoliation glaucoma. We defined a successful surgery by the following three scores: an IOP reduction > 20% and IOP at the longest follow-up < 21 mmHg (Score A) or < 18 mmHg (Score B) or IOP ≤ 15 mmHg and an IOP reduction ≥ 40% (Score C). One open conjunctival revision was allowed in all scores, and a repeat surgery was considered a failure. Results Following an average follow-up period of 22 ± 12 months, we observed a mean IOP reduction of 38%, from 23.5 ± 5.2–14.5 ± 5.0 mmHg. Comparative analyses between the groups did not reveal a significant difference in the postoperative IOP, postoperative medication score, side effects, revision rate, repeat surgery rate, or success rate. Conclusions Trabectome is a viable first-line procedure for medically uncontrolled glaucoma before filtering ab-interno microstent surgery is considered.

scholarly journals SUBCHRONIC TOXICITY TEST OF COMBINATION ETHANOL EXTRACT OF DETAM 1 SOYBEAN (GLYCINE MAX L. MERR) AND JATI BELANDA (GUAZUMA ULMIFOLIA LAMK) TOWARD FUNCTION, WEIGHT, AND HISTOPATHOLOGICAL OF WISTAR RAT LIVER

2016 ◽  
Vol 9 (5) ◽  
pp. 197
Author(s):  
Meilinah Hidayat ◽  
Sijani Prahastuti ◽  
Estherolita Dewi ◽  
Dewi Safitri ◽  
Siti Farah Rahmawati ◽  
...  
Keyword(s):  
Liver Function ◽  
Toxicity Test ◽  
Low Dose ◽  
Ethanol Extract ◽  
Good Effect ◽  
Control Group ◽  
High Dose ◽  
Subchronic Toxicity ◽  
Treatment Groups ◽  
Significant Difference

ABSTRACTObjective: As an antiobesity therapy, combination extracts of Detam 1 soybean and Jati Belanda will be consumed for a long time; therefore, theirtoxicities to the liver need to be investigated. To determine the effect of subchronic toxicity test of combination of ethanol extract of Detam 1 soybean(EEDS) and ethanol extract of Jati Belanda (EEJB) on liver function with parameters: Alanine transaminase (ALT), macroscopic, and histopathologicalof liver.Methods: This study was conducted on 120 Wistar rats (60 males and 60 females), 90 days (treatment group) and 120 days (satellite group). Ratswere divided into six treatment groups (3 test materials, 1 control, and 2 satellites); each group included 10 males and 10 females.Results: ALT levels of treatment groups (low dose, medium, and high), both males and females were lower than the control group (p<0.05). Thetreatment groups demonstrated a good effects effect on liver function. Liver weight of all groups showed no significant difference compared with thecontrol group (p>0.05). Results of histopathological score interpretation of male and female liver rats of low dose groups were not disturbed; middledose groups were slightly disturbed and high dose groups were damaged. Satellite high doses of male groups were disrupted, while female groupswere not.Conclusion: The combination of EEDS and EEJB has a good effect on liver function, did not lead to change organ weight and at low doses did not causerenal histopathology damage in rats after 90 days administration.Keywords: Combination of soybean Jati Belanda, Toxicity subchronic test, Function, Weight, Histopathology, Liver.

scholarly journals Treatment of thoracolumbar trauma by short-segment percutaneous transpedicular screw instrumentation: prospective comparative study with a minimum 2-year follow-up

2014 ◽  
Vol 20 (2) ◽  
pp. 150-156 ◽  
Author(s):  
Petr Vanek ◽  
Ondrej Bradac ◽  
Renata Konopkova ◽  
Patricia de Lacy ◽  
Jiri Lacman ◽  
...  
Keyword(s):  
Blood Loss ◽  
Minimally Invasive ◽  
Cobb Angle ◽  
Control Group ◽  
Working Ability ◽  
Short Segment ◽  
Transpedicular Screw ◽  
Significant Difference ◽  
Screw Group

Object The main aim of this study was to compare clinical and radiological outcomes after stabilization by a percutaneous transpedicular system and stabilization from the standard open approach for thoracolumbar spine injury. Methods Thirty-seven consecutive patients were enrolled in the study over a period of 16 months. Patients were included in the study if they experienced 1 thoracolumbar fracture (A3.1–A3.3, according to the AO/Magerl classification), had an absence of neurological deficits, had no other significant injuries, and were willing to participate. Eighteen patients were treated by short-segment, minimally invasive, percutaneous pedicle screw instrumentation. The control group was composed of 19 patients who were stabilized using a short-segment transpedicular construct, which was performed through a standard midline incision. The pain profile was assessed by a visual analog scale (VAS), and overall satisfaction by a simple 4-stage scale relating to performance of daily activities. Working ability and return to original occupation were also monitored. Radiographic follow-up was defined by the vertebral body index (VBI), vertebral body angle (VBA), and bisegmental Cobb angle. The accuracy of screw placement was examined using CT. Results The mean surgical duration in the percutaneous screw group was 53 ± 10 minutes, compared with 60 ± 9 minutes in the control group (p = 0.032). The percutaneous screw group had a significantly lower perioperative blood loss of 56 ± 17 ml, compared with 331 ± 149 ml in the control group (p < 0.001). Scores on the VAS in patients in the percutaneous screw group during the first 7 postoperative days were significantly lower than those in the control group (p < 0.001). There was no significant difference between groups in VBI, VBA, and Cobb angle values during follow-up. There was no significant difference in screw placement accuracy between the groups and no patients required surgical revision. There was no significant difference between groups in overall satisfaction at the 2-year follow-up (p = 0.402). Working ability was insignificantly better in the percutaneous screw group; previous working position was achieved in 17 patients in this group and in 12 cases in the control group (p = 0.088). Conclusions This study confirms that the percutaneous transpedicular screw technique represents a viable option in the treatment of preselected thoracolumbar fractures. A significant reduction in blood loss, postoperative pain, and surgical time were the main advantages associated with this minimally invasive technique. Clinical, functional, and radiological results were at least the same as those achieved using the open technique after a 2-year follow-up. The short-term benefits of the percutaneous transpedicular screw technique are apparent, and long-term results have to be studied in other well-designed studies evaluating the theoretical benefit of the percutaneous technique and assessing whether the results of the latter are as durable as the ones achieved by open surgery.

Outcomes of Inside-out Meniscal Repair in the Setting of Multiligament Reconstruction in the Knee

2017 ◽  
Vol 45 (9) ◽  
pp. 2098-2104 ◽  
Author(s):  
Jorge Chahla ◽  
Chase S. Dean ◽  
Lauren M. Matheny ◽  
Justin J. Mitchell ◽  
Mark E. Cinque ◽  
...  
Keyword(s):  
Failure Rate ◽  
Meniscal Repair ◽  
Postoperative Outcome ◽  
Control Group ◽  
Failure Rates ◽  
Significant Difference ◽  
Outcome Scores ◽  
Inside Out ◽  
Repair Group

Background: Limited evidence exists for meniscal repair outcomes in a multiligament reconstruction setting. Purpose/Hypothesis: The purpose of this study was to assess outcomes and failure rates of meniscal repair in patients who underwent multiligament reconstruction compared with patients who underwent multiligament reconstruction but lacked meniscal tears. The authors hypothesized that the outcomes of meniscal repair associated with concomitant multiligament reconstruction would significantly improve from preoperatively to postoperatively at a minimum of 2 years after the index surgery. Secondarily, they hypothesized that this cohort would demonstrate similar outcomes and failure rates compared with the cohort that did not have meniscal lesions at the time of multiligament reconstruction. Study Design: Cohort study; Level of evidence, 3. Methods: Inclusion criteria for the study included radiographically confirmed skeletally mature patients of at least 16 years of age who underwent multiligamentous reconstruction of the knee without previous ipsilateral osteotomy, intra-articular infections, or intra-articular fractures. Patients were included in the experimental group if they underwent inside-out meniscal suture repair with concurrent multiligament reconstruction. Those included in the control group (multiligament reconstruction without a meniscal tear) underwent multiligament reconstruction but did not undergo any type of meniscal surgery. Lysholm, Western Ontario and McMaster Universities Osteoarthritis Index, Short Form–12 physical component summary and mental component summary, Tegner activity scale, and patient satisfaction scores were recorded preoperatively and postoperatively. The failure of meniscal repair was defined as a retear of the meniscus that was confirmed arthroscopically. Results: There were 43 patients (16 female, 27 male) in the meniscal repair group and 62 patients (25 female, 37 male) in the control group. Follow-up was obtained in 93% of patients with a mean of 3.0 years (range, 2.0-4.7 years). There was a significant improvement between all preoperative and postoperative outcome scores ( P < .05) for both groups. The meniscal repair group had significantly lower preoperative Lysholm and Tegner scores ( P = .009 and P = .02, respectively). There were no significant differences between any other outcome scores preoperatively. The failure rate of the meniscal repair group was 2.7%, consisting of 1 symptomatic meniscal retear. There was no significant difference in any postoperative outcome score at a minimum 2-year follow-up between the 2 groups. Conclusion: Good to excellent patient-reported outcomes were reported for both groups with no significant differences in outcomes between the cohorts. Additionally, the failure rate for inside-out meniscal repair with concomitant multiligament reconstruction was low, regardless of meniscus laterality and tear characteristics. The use of multiple vertical mattress sutures and the biological augmentation resulting from intra-articular cruciate ligament reconstruction tunnel reaming may be partially responsible for the stability of the meniscal repair construct and thereby contribute to the overall improved outcomes and the low failure rate of meniscal repair, despite lower preoperative Lysholm and Tegner scores in the meniscal repair group.

A prospective randomized study to assess the efficacy of post-operative nasal medication after endonasal surgery

1995 ◽  
Vol 109 (7) ◽  
pp. 618-621 ◽  
Author(s):  
Paul D. R. Spraggs ◽  
Marcelle Macnamara ◽  
Theo Joseph
Keyword(s):  
Randomized Study ◽  
Correlation Coefficients ◽  
Control Group ◽  
Time Intervals ◽  
Treatment Groups ◽  
Ephedrine Hydrochloride ◽  
Patent Airway ◽  
Significant Difference ◽  
Blood Clots ◽  
Betamethasone Sodium Phosphate

AbstractPost-operative nasal medications are commonly used following routine septal or turbinate surgery but their efficacy in removing blood clots, improving the sensation of a patent airway and promoting healing are unknown. This prospective randomized trial of patients undergoing septal and/or turbinate surgery assessed the efficacy of three commonly used nasal medicines, 0.5 per cent ephedrine hydrochloride nasal drops, betamethasone sodium phosphate (Betnosol®) nose drops and alkaline nasal douches, in producing the sensation of a patent airway in the 14 days following surgery. Ninety-seven patients were randomized into the three treatment groups and a control group who received no nasal medication. Patients assessed their nasal patency by means of a visual analogue scale (VAS) and any complications of treatment were recorded. Statistical analysis of the 76 complete sets of results using the Mann-Whitney U-test showed that there was a significant difference in the distribution of all of the treatments for each of the time intervals (p<0.05). Glass rank biserial correlation coefficients were all small (rg<0.085) but the most significant differences were between ephedrine and the control group at two hours, two, seven and 10 days (0.02, 0.054, 0.057, 0.085 respectively), alkaline nasal douches being most significant at four and 14 days (0.06 and 0.0722 respectively).

Chronic Achilles Tendinopathy

2007 ◽  
Vol 35 (10) ◽  
pp. 1659-1667 ◽  
Author(s):  
Wolf Petersen ◽  
Robert Welp ◽  
Dieter Rosenbaum
Keyword(s):  
Synergistic Effect ◽  
Short Form ◽  
Achilles Tendinopathy ◽  
Eccentric Training ◽  
Treatment Groups ◽  
Alternative Treatment Option ◽  
Sf 36 ◽  
Significant Difference ◽  
Chronic Achilles Tendinopathy

Background Previous studies have shown that eccentric training has a positive effect on chronic Achilles tendinopathy. A new strategy for the treatment of chronic Achilles tendinopathy is the AirHeel brace. Hypothesis AirHeel brace treatment improves the clinical outcome of patients with chronic Achilles tendinopathy. The combination of the AirHeel brace and an eccentric training program has a synergistic effect. Study Design Randomized controlled clinical trial; Level of evidence, 1. Methods One hundred patients were randomly assigned to 1 of 3 treatment groups: (1) eccentric training, (2) AirHeel brace, and (3) combination of eccentric training and AirHeel brace. Patients were evaluated at 6, 12, and 54 weeks after the beginning of the treatment protocol with ultrasonography, visual analog scale (VAS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) ankle score, and Short Form-36 (SF-36). Results The VAS score for pain, AOFAS score, and SF-36 improved significantly in all 3 groups at all 3 follow-up examinations. At the 3 time points (6 weeks, 12 weeks, and 54 weeks) of follow-up, there was no significant difference between all 3 treatment groups. In all 3 groups, there was no significant difference in tendon thickness after treatment. Conclusions The AirHeel brace is as effective as eccentric training in the treatment of chronic Achilles tendinopathy. There is no synergistic effect when both treatment strategies are combined. Clinical Relevance The AirHeel brace is an alternative treatment option for chronic Achilles tendinopathy.

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