EVALUATION OF A TREATMENT ALGORITHM FOR PATIENTS WITH PATELLOFEMORAL PAIN SYNDROME: A PILOT STUDY

Background:

Treatment of patellofemoral pain syndrome (PFPS) has been extensively studied in physical therapy literature. Patients with PFPS demonstrate quadriceps and hip musculature weakness, altered lower extremity (LE) kinematics, and decreased LE flexibility. Psychosocial factors have also been identified as an important factor in patients with PFPS. The authors hypothesize that an ordered approach addressing each of these impairments sequentially will result in greater improvement in PFPS symptoms. The purpose of this pilot study was to assess the feasibility of performing a randomized trial and to determine the sample size necessary to examine the validity of this hypothesis.

Methods:

Patients received a sequential treatment approach using a PFPS treatment algorithm (PFPS Algorithm) designed by the authors. Patients were evaluated assessing psychosocial factors, flexibility, LE kinematics, and LE strength. Impairments that were found in the evaluation were addressed sequentially over the episode of care. Patients were prescribed therapy two times per week for six weeks. Pain, Anterior Knee Pain Scale (AKPS), and Global Rating of Change (GROC) were measured at evaluation and discharge.

Results:

Thirty consecutive patients with PFPS who were referred to physical therapy were enrolled in the pilot study. All phases of the feasibility study including recruitment, treatment protocols and data collection were effectively carried out. One hundred percent of patients treated with the PFPS algorithm who completed the prescribed treatment had a clinically significant improvement in the AKPS and GROC. A floor effect was noted with NPRS with 38% of patients unable to achieve clinically significant improvement.

Conclusions:

With minor changes to the protocol and outcome measures used, a full randomized trial is feasible and merited. Steps must be taken to reduce the high drop‐out rate among both groups.

Level of Evidence:

1b     

Manual physical therapy and perturbation exercises in knee osteoarthritis

Objectives:

Knee osteoarthritis (OA) causes disability among the elderly and is often associated with impaired balance and proprioception. Perturbation exercises may help improve these impairments. Although manual physical therapy is generally a well-tolerated treatment for knee OA, perturbation exercises have not been evaluated when used with a manual physical therapy approach. The purpose of this study was to observe tolerance to perturbation exercises and the effect of a manual physical therapy approach with perturbation exercises on patients with knee OA.

Methods:

This was a prospective observational cohort study of 15 patients with knee OA. The Western Ontario and McMaster Universities Arthritis Index (WOMAC), global rating of change (GROC), and 72-hour post-treatment tolerance were primary outcome measures. Patients received perturbation balance exercises along with a manual physical therapy approach, twice weekly for 4 weeks. Follow-up evaluation was done at 1, 3, and 6 months after beginning the program.

Results:

Mean total WOMAC score significantly improved (P = 0.001) after the 4-week program (total WOMAC: initial, 105; 4 weeks, 56; 3 months, 54; 6 months, 57). Mean improvements were similar to previously published trials of manual physical therapy without perturbation exercises. The GROC score showed a minimal clinically important difference (MCID)≥+3 in 13 patients (87%) at 4 weeks, 12 patients (80%) at 3 months, and 9 patients (60%) at 6 months. No patients reported exacerbation of symptoms within 72 hours following each treatment session.

Discussion:

A manual physical therapy approach that also included perturbation exercises was well tolerated and resulted in improved outcome scores in patients with knee OA.     

Lumbopelvic manipulation in patients with patellofemoral pain syndrome

Objectives:

A recent clinical prediction rule (CPR) identified characteristics that may predict an immediate reduction in pain following lumbopelvic manipulation in patients with patellofemoral pain syndrome. The purpose of this single-arm cohort study was to replicate the proposed CPR in a different population and investigate changes in self-reported pain, hip range of motion, strength, and function immediately following lumbopelvic manipulation.

Methods:

Forty-four subjects (63·6% female; mean age 27·4 years) met inclusion criteria. Hip internal rotation range of motion, lower extremity strength using a handheld dynamometer, and single/triple hop tests were assessed prior to and immediately following a spinal manipulation. A global rating of change questionnaire was administered after testing and telephonically at 1 week. Paired t-tests compared pre- and post-manipulation range of motion, strength, and hop test limb symmetry indices (α = 0·05).

Results:

Fifty-seven percent of subjects had a successful outcome measured by the numerical pain rating scale immediately following manipulation. Twenty-five of subjects experienced a successful outcome as measured by the global rating of change questionnaire at 1 week. No single individual or combination of predictor variables predicted a positive outcome immediately following the lumbopelvic manipulation (+likelihood ratio 0·7 with three of five predictor variables present). Statistically significant differences (P<0·05) were found in hip extension and abduction strength and hip internal rotation symmetry post-manipulation, but do not appear to be clinically meaningful.

Discussion:

The previously identified CPR was not able to be replicated and no clinically meaningful changes in range of motion, strength, or function were apparent. Future research should focus on a comprehensive impairment-based treatment approach in patients with patellofemoral pain syndrome.     

The effectiveness of strain counterstrain in the treatment of patients with chronic ankle instability: A randomized clinical trial

Study Design:

Randomized clinical trial.

Objective:

To determine the effect of strain counterstrain (SCS) on dynamic balance and subjective sense of instability in individuals with chronic ankle instability (CAI).Although many studies have been published on CAI, the cause for this common clinical dysfunction remains inconclusive. No studies have assessed the effectiveness of SCS on CAI.

Methods:

At baseline all participants completed a demographic questionnaire, the star excursion balance test (SEBT), and the foot and ankle ability measure (FAAM). Following the baseline evaluation, participants were randomized into the SCS experimental group (EG) (n = 13) or the sham SCS group (SG) (n = 14). All participants received the assigned treatment once a week for 4 weeks and participated in a prescribed exercise program. At week 4, all participants repeated the outcome measures and completed a global rating of change (GROC) form. The primary aim was examined with a two-way analysis of variance (ANOVA).

Results:

A significant group-by-time interaction was found for seven directions in the SEBT (P<0.031). For subjective measures, no significant group-by-time interaction was found for the FAAM (P>0.548), but the GROC revealed a significant difference (P = 0.014) in the mean score for the EG (3.92±1.66) when compared to the SG (2.43±1.66).

Discussion:

Although SCS may not have an effect on subjective ankle function in individuals with CAI, preliminary evidence suggests that SCS may lead to an improvement in dynamic ankle stability and the subjective sense of ankle instability.

Level of Evidence:

Therapy, Level 1b.     

PATELLOFEMORAL PAIN SUBJECTS EXHIBIT DECREASED PASSIVE HIP RANGE OF MOTION COMPARED TO CONTROLS

Background:

Patellofemoral pain is a common condition without a clear mechanism for its presentation. Recently significant focus has been placed on the hip and its potential role in patellofemoral pain (PFP). The majority of the research has examined hip strength and neuromuscular control. Less attention has been given to hip mobility and its potential role in subjects with PFP.

Purpose/Aim:

The purpose of this study was to compare passive hip range of motion (ROM) of hip extension and hip internal and external rotation in subjects with PFP and healthy control subjects. The hypothesis was that subjects with PFP would present with less total hip ROM and greater asymmetry than controls.

Design:

Two groups, case controlled.

Setting:

Clinical research laboratory

Participants:

30 healthy subjects without pain, radicular symptoms or history of surgery in the low back or lower extremity joints and 30 subjects with a diagnosis of PFP.

Main Outcome Measures:

Passive hip extension, hip internal rotation (IR) and hip external rotation (ER). A digital inclinometer was used for measurements.

Results:

There was a statistically significant difference (p<0.001) in hip passive extension between the control group and the PFP group bilaterally. Mean hip extension for the control group was 6.8° bilaterally. For the PFP group, the mean hip extension was −4.0° on the left and −4.3° on the right. This corresponds to a difference of means between groups of 10.8° on the left and 11.1° on the right with a standard error of 2.1°. There was no statistically significant difference (p>0.05) in either hip IR or ER ROM or total rotation between or within groups.

Conclusions:

The results of this study indicate that a significant difference in hip extension exists in subjects with PFP compared to controls. These findings suggest that passive hip extension is a variable that should be included within the clinical examination of people with PFP. It may be valuable to consider hip mobility restrictions and their potential impact on assessment of strength and planned intervention in subjects with PFP.

Level of Evidence:

2b     

THE MINIMUM CLINICALLY IMPORTANT DIFFERENCE ON THE VISA‐A AND LEFS FOR PATIENTS WITH INSERTIONAL ACHILLES TENDINOPATHY

Study Design

Cohort study of subjects with insertional Achilles tendinopathy (IAT).

Objectives

The purpose of this study was to establish the minimum clinically important difference (MCID) on the Victorian Institute of Sport Assessment ‐ Achilles Questionnaire (VISA‐A) and the Lower Extremity Functional Scale (LEFS) for patients with IAT.

Background

The VISA‐A and LEFS are two measures commonly utilized for patients with IAT. Previous authors have estimated the MCID for the VISA‐A, but a MCID has not been formally established. The MCID for the LEFS has been established for patients with lower extremity conditions in general, but it is not clear if this MCID is applicable to patients with IAT.

Methods

Fifteen subjects participating in a randomized controlled trial studying the effectiveness of intervention for IAT over a 12‐week period were included in this study. Subjects completed the VISA‐A and LEFS forms at baseline and 12 weeks after the initiation of treatment. All subjects also completed a 15‐point global rating of change (GROC) questionnaire at 12 weeks after the initiation of treatment. Subjects were classified as improved or stable based on their GROC scores.

Results

The area under the curve (AUC) for the VISA‐A was 0.97 and a MCID of 6.5 points was identified. The AUC for the LEFS was 0.97 and a MCID of 12 points was identified.

Conclusion

The VISA‐A and LEFS are both useful outcome measures to assess response in patients with IAT.

Level of Evidence

3     

REHABILITATION AFTER HIP ARTHROSCOPY AND LABRAL REPAIR IN A HIGH SCHOOL FOOTBALL ATHLETE

Study Design:

Case Report

Background:

Femoral acetabular impingement (FAI) has been implicated in the etiology of acetabular labral tears. The rehabilitation of younger athletes following arthroscopic surgery for FAI and labral tears is often complex and multifactorial. A paucity of evidence exists to describe the rehabilitation of younger athletes who have undergone arthroscopic hip surgery.

Case Presentation:

This case report describes a four-phase rehabilitation program for a high school football player who underwent hip arthroscopy with a labral repair and chondroplasty.

Outcomes:

The player returned to training for football 16 weeks later and at the 4 month follow-up was pain free with no signs of FAI.

Discussion:

There is little evidence regarding the rehabilitation of younger athletes who undergo arthroscopic hip surgery. This case study described a four phase rehabilitation program for a high school football player who underwent hip arthroscopy and labral repair. The patient achieved positive outcomes with a full return to athletic activity and football. The overall success of these patients depends on the appropriate surgical procedure and rehabilitation program.

Key Words:

Femoral acetabular impingement (FAI), hip, hip impingement

Level of evidence:

4-Case report     

Hip Symptoms,Physical Performance,and Health Status in Older Adults With Chronic Low Back Pain: A Preliminary Investigation

Objectives

To determine (1) whether there are differences in the prevalence of clinical hip symptoms between older adults with and without chronic low back pain (CLBP); and (2) whether coexisting hip symptoms are associated with worse physical performance and poorer health-related quality of life (HRQOL).

Effectiveness of hip muscle strengthening in patellofemoral pain syndrome patients: a systematic review

Introduction:

Patellofemoral pain syndrome (PFPS) is characterized by anterior knee pain, which may limit the performance of functional activities. The influence of hip joint motion on the development of this syndrome has already been documented in the literature. In this regard, studies have investigated the effectiveness of hip muscle strengthening in patients with PFPS.

Objectives:

The aims of this systematic review were (1) to summarize the literature related to the effects of hip muscle strengthening on pain intensity, muscle strength, and function in individuals with PFPS and (2) to evaluate the methodological quality of the selected studies.

Method:

A search for randomized controlled clinical trials was conducted using the following databases: Google Scholar, MEDLINE, PEDro, LILACS, and SciELO. The selected studies had to distinguish the effects of hip muscle strengthening in a group of patients with PFPS, as compared to non-intervention or other kinds of intervention, and had to investigate the following outcomes: pain, muscle strength, and function. The methodological quality of the selected studies was analyzed by means of the PEDro scale.

Results:

Seven studies were selected. These studies demonstrated that hip muscle strengthening was effective in reducing pain. However, the studies disagreed regarding the treatments'' ability to improve muscle strength. Improvement in functional capabilities after hip muscle strengthening was found in five studies.

Conclusion:

Hip muscle strengthening is effective in reducing the intensity of pain and improving functional capabilities in patients with PFPS, despite the lack of evidence for its ability to increase muscle strength.     

PASSIVE HIP RANGE OF MOTION IS REDUCED IN ACTIVE SUBJECTS WITH CHRONIC LOW BACK PAIN COMPARED TO CONTROLS

Background

Non‐specific low back pain is a common condition often without a clear mechanism for its presentation. Recently more attention has been placed on the hip and its potential contributions to non‐specific chronic low back pain (NSCLBP). Emphasis in research has mainly been placed on motor control, strength and endurance factors in relation to NSCLBP. Limited focus has been placed on hip mobility and its potential contribution in subjects with NSCLBP.

Purpose/Aim

The aim of this study was to compare passive ROM in hip extension, hip internal rotation, hip external rotation and total hip rotation in active subjects with NSCLBP to healthy control subjects. The hypothesis was that active subjects with NSCLBP would present with decreased total hip ROM and greater asymmetry when compared to controls.

Design

Two group case controlled

Setting

Clinical research laboratory

Participants

30 healthy subjects without NSCLBP and 30 active subjects with NSCLBP. Subjects categorized as NSCLBP were experiencing pain in the low back area with or without radicular symptoms of greater than three months duration.

Main Outcome Measure

Passive hip extension (EXT), hip internal rotation (IR), hip external rotation (ER) and total hip rotation ROM. A digital inclinometer was used for measurements.

Results

There was a statistically significant difference (p<0.001) in hip passive extension ROM between the control group and the NSCLBP group bilaterally. Mean hip extension for the control group was 6.88 bilaterally. For the NSCLBP group, the mean hip extension was ‐4.28 bilaterally. This corresponds to a difference of means between groups of 10.88. There was no statistically significant differences (p>0.05) in hip IR, ER, or total rotation ROM between groups.

Conclusions

The results of this study indicate that a significant difference in hip extension exists in active subjects with NSCLBP compared to controls. It may be important to consider hip mobility restrictions and their potential impact on assessment of strength in NSLBP subjects. Future studies may be needed to investigate the relationship between measurements and intervention strategies.

Level of Evidence

2b     

Argatroban versus Lepirudin in critically ill patients (ALicia): a randomized controlled trial

Introduction

Critically ill patients often require renal replacement therapy accompanied by thrombocytopenia. Thrombocytopenia during heparin anticoagulation may be due to heparin-induced thrombocytopenia with need for alternative anticoagulation. Therefore, we compared argatroban and lepirudin in critically ill surgical patients.

Methods

Following institutional review board approval and written informed consent, critically ill surgical patients more than or equal to 18 years with suspected heparin-induced thrombocytopenia, were randomly assigned to receive double-blind argatroban or lepirudin anticoagulation targeting an activated Partial Thromboplastin Time (aPTT) of 1.5 to 2 times baseline. In patients requiring continuous renal replacement therapy we compared the life-time of hemodialysis filters. We evaluated in all patients the incidence of bleeding and thrombembolic events.

Results

We identified 66 patients with suspected heparin-induced thrombocytopenia, including 28 requiring renal replacement therapy. Mean filter lifetimes did not differ between groups (argatroban 32 ± 25 hours (n = 12) versus lepirudin 27 ± 21 hours (n = 16), mean difference 5 hours, 95% CI −13 to 23, P = 0.227). Among all 66 patients, relevant bleeding occurred in four argatroban- versus eleven lepirudin-patients (OR 3.9, 95% CI 1.1 to 14.0, P = 0.040). In the argatroban-group, three thromboembolic events occurred compared to two in the lepirudin group (OR 0.7, 95% CI 0.1 to 4.4, P = 0.639). The incidence of confirmed heparin-induced thrombocytopenia was 23% (n = 15) in our study population.

Conclusions

This first randomized controlled double-blind trial comparing two direct thrombin inhibitors showed comparable effectiveness for renal replacement therapy, but suggests fewer bleeds in surgical patients with argatroban anticoagulation.

Trial registration

Clinical Trials.gov {"type":"clinical-trial","attrs":{"text":"NCT00798525","term_id":"NCT00798525"}}NCT00798525. Registered 25 November 2008

Electronic supplementary material

The online version of this article (doi:10.1186/s13054-014-0588-8) contains supplementary material, which is available to authorized users.     

Characteristics of chronic pain patients in a rural teaching practice

Objective

To describe the characteristics of chronic noncancer pain (CNCP) patients taking oxycodone or its derivatives in a rural teaching practice.

Design

Characteristics of CNCP patients taking oxycodone over a 5-year period (September 2003 to September 2008) were compared with those of patients not taking opioid medications using a retrospective chart audit.

Setting

A rural teaching practice in southwestern Ontario.

Participants

A total of 103 patients taking chronic oxycodone therapy for CNCP and a random sample of 104 patients not taking opioid medication.

Main outcome measures

Number of visits, health problems, sex, and previous history of addiction and mental illness.

Results

Patients with CNCP taking oxycodone had significantly more health problems (P < .001), including drug and tobacco addictions. They had more than 3 times as many clinic visits during the same period of time as patients not taking opioid medication (mean of 39.0 vs 12.8 visits, P < .001).

Conclusion

Patients with CNCP in this rural teaching practice had significantly more health issues (P < .001) and were more likely to have a history of addiction than other patients were. They created more work with significantly more visits over the same period compared with the comparison group.     

Evaluation of focussed assessment with sonography in trauma (FAST) by UK emergency physicians

Objectives

To evaluate the introduction of a focussed assessment with sonography in trauma (FAST) scan into the early assessment of trauma patients in the UK.

Methods

The setting was an inner city teaching hospital emergency department (annual attendance 100 000). All patients aged 16 or over admitted to the resuscitation room after blunt trauma were included in a prospective observational study. Patients had a FAST scan performed at the end of the primary survey. Results were compared to results of other investigations, laparotomy, postmortem examination, or observation.

Results

153 patients were entered into the study. The sensitivity of the FAST scan was 78% and specificity was 99%.

Conclusion

FAST is a highly specific “rule in” technique and is useful in the initial assessment of trauma patients. Emergency physicians can perform FAST after a brief training period.     

Potential health promotion benefits of lipid testing for all patients presenting with chest pain to an emergency department

Objectives

To establish the prevalence of previously undiagnosed dyslipidaemia in patients presenting to the emergency department (ED) with non‐traumatic chest pain and, more particularly, the prevalence in the subgroup which was discharged home from the ED, the group that traditionally would not have received a lipid test.

Methods

Prospective, observational study of adult patients presenting to an ED with non‐traumatic chest pain as the presenting complaint.

Results

A total of 185 eligible patients underwent lipid testing during their presentation: 96 in the ED and 89 in the wards. Overall 61% (n = 112) of patients had at least one abnormal lipid level. Of patients discharged from the ED, 62% had at least one abnormal lipid level.

Conclusions

A moderate, but useful, increase in detection rates of dyslipidaemia is possible if lipid testing is offered to all patients presenting with chest pain, and not just to those who are admitted to wards for further investigation and management of suspected acute coronary syndromes. Testing of this group should be considered as a health promotion initiative in the ED, with appropriate follow up in the community.     

CLINICAL APPLICATION OF THE RIGHT SIDELYING RESPIRATORY LEFT ADDUCTOR PULL BACK EXERCISE

Problem:

Lumbopelvic‐femoral conditions are common and may be associated with asymmetrical musculoskeletal and respiratory impairments and postural mal‐alignment called a Left Anterior Interior Chain (AIC) pattern. An inherent pattern of asymmetry involves the trunk/ribs/spine/pelvis/hip joints and includes the tendency to stand on the right leg and shift the center of gravity to the right which may result for example, in a tight left posterior hip capsule, poorly approximated left hip, long/weak left adductors, internal obliques (IO) and transverse abdominus (TA), short/strong/over active paraspinals and muscles on the right anterior outlet (adductors, levator ani and obturator internus), a left rib flare and a decreased respiratory diaphragm zone of apposition (ZOA).

The Solution:

A therapeutic exercise technique that can address impairments associated with postural asymmetry may be beneficial in improving function, reducing and/or eliminating pain causation, and improving breathing. The Right Sidelying Left Respiratory Adductor Pull Back is an exercise designed to affect alignment of the lumbopelvic‐femoral region by influencing the left posterior ischiofemoral ligament, ZOA and right anterior outlet and left anterior inlet (rectus femoris, sartorius), activating/shortening the left adductors, left IO/TA''s and inhibiting/lengthening the paraspinals, bilaterally.

Discussion:

The exercise technique is often used by Physical Therapists, Physical Therapist assistants and Athletic Trainers as an initial exercise to positively affect position/alignment of the lumbopelvic‐femoral region, referred to as “repositioning,” by clinicians who use it. Four published case studies have used similar exercises to address the above impairments associated with a Left AIC pattern and in each 100% improvement in function and pain intensity was described. This particular exercise technique is relatively new and warrants future research.     

Increased Left Ventricular Torsion in Uncomplicated Type 1 Diabetic Patients: The role of coronary microvascular function

OBJECTIVE

We used speckle tracking echocardiography to study the early changes in left ventricular (LV) torsion in young patients with uncomplicated type 1 diabetes and stress magnetic resonance imaging (MRI) to assess its interrelationships with coronary microangiopathy.

RESEARCH DESIGN AND METHODS

We recruited 33 asymptomatic subjects with type 1 diabetes and 32 age-matched healthy control subjects. All subjects underwent echocardiograms. Stress MRIs were performed in 30 subjects (8 healthy control subjects) to compute myocardial perfusion reserve index (MPRI).

RESULTS

A significant increase in LV torsion (2 ± 0.7 vs. 1.4 ± 0.7°/cm, P < 0.05) was identified in longer-term and retinopathy-positive type 1 diabetic subjects (1.9 ± 0.7 vs. 1.4 ± 0.7°/cm, P < 0.05) as compared with the healthy control subjects. The MPRI was independently associated with increased LV torsion.

CONCLUSIONS

We demonstrate that LV torsion is increased in young patients with uncomplicated type 1 diabetes and that coronary microvascular disease may play a key pathophysiological role in the development of increased LV torsion.There is increasing evidence for the presence of diabetic cardiomyopathy as a separate entity. However, detection of early changes in the myocardium is challenging in patients with diabetes. Speckle tracking echocardiography is a novel method of measuring left ventricular (LV) strain and rotation (1,2). Previous studies with tagged magnetic resonance imaging (MRI) have shown increased torsion in both patients with type 1 and type 2 diabetes (3,4). The main aim of this study was to confirm and extend these findings by exploring the potential pathophysiological mechanisms involved. We utilized speckle tracking to measure LV torsion and stress MRI to compute myocardial perfusion reserve index (MPRI), which is a measure of coronary microvascular function.     

Extracorporeal cell therapy of septic shock patients with donor granulocytes: a pilot study

Introduction

Neutrophil granulocytes are the first defense line in bacterial infections. However, granulocytes are also responsible for severe local tissue impairment. In order to use donor granulocytes, but at the same time to avoid local side effects, we developed an extracorporeal immune support system. This first-in-man study investigated whether an extracorporeal plasma treatment with a granulocyte bioreactor is tolerable in patients with septic shock. A further intention was to find suitable efficacy end-points for subsequent controlled trials.

Methods

The trial was conducted as a prospective uncontrolled clinical phase I/II study with 28-day follow-up at three university hospital intensive care units. Ten consecutive patients (five men, five women, mean age 60.3 ± 13.9 standard deviation (SD) years) with septic shock with mean ICU entrance scores of Acute Physiology and Chronic Health Evaluation (APACHE) II of 29.9 ± 7.2 and of Simplified Acute Physiology Score (SAPS) II of 66.2 ± 19.5 were treated twice within 72 hours for a mean of 342 ± 64 minutes/treatment with an extracorporeal bioreactor containing 1.41 ± 0.43 × 10E10 granulocytes from healthy donors. On average, 9.8 ± 2.3 liters separated plasma were treated by the therapeutic donor cells. Patients were followed up for 28 days.

Results

Tolerance and technical safety during treatment, single organ functions pre/post treatment, and hospital survival were monitored. The extracorporeal treatments were well tolerated. During the treatments, the bacterial endotoxin concentration showed significant reduction. Furthermore, noradrenaline dosage could be significantly reduced while mean arterial pressure was stable. Also, C-reactive protein, procalcitonin, and human leukocyte antigen DR (HLA-DR) showed significant improvement. Four patients died in the hospital on days 6, 9, 18 and 40. Six patients could be discharged.

Conclusions

The extracorporeal treatment with donor granulocytes appeared to be well tolerated and showed promising efficacy results, encouraging further studies.

Trial registration

ClinicalTrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT00818597","term_id":"NCT00818597"}}NCT00818597