Stability and migration across femoral varus derotation osteotomies in children with neuromuscular disorders.

Background and purpose - Studies have indicated that one-third of children with cerebral palsy (CP) develop dislocation of the hip that needs surgical intervention. When hip dislocation occurs during childhood surgical treatment consists of tenotomies, femoral varus derotation osteotomy (VDRO), and acetabuloplasty. Relapse is observed in one-fifth of cases during adolescence. In this prospective cohort study, we performed a descriptive evaluation of translation and rotation across VDROs in children with neuromuscular disorders and syndromes by radiostereometric analysis (RSA). We assessed "RSA stability" and migration across the VDROs. Patients and methods - Children with a neuromuscular disorder were set up for skeletal corrective surgery of the hip. RSA follow-ups were performed postoperatively, at 5 weeks, and 3, 6, and 12 months after surgery. Results - 27 femoral VDROs were included; 2 patients were excluded during the study period. RSA data showed stability across the VDRO in the majority of cases within the first 5 weeks. At the 1-year follow-up, the mean translations (SD) of the femoral shaft distal to the VDRO were 0.51 (1.12) mm medial, 0.69 (1.61) mm superior, and 0.21 (1.28) mm posterior. The mean rotations were 0.39° (2.90) anterior tilt, 0.02° (3.07) internal rotation, and 2.17° (2.29) varus angulation. Interpretation - The migration stagnates within the first 5 weeks, indicating stability across the VDRO in most patients.

The central role of trunk control in the gross motor function of children with cerebral palsy: a retrospective cross-sectional study.

AIM: Improvement of gross motor function and mobility are primary goals of physical therapy in children with cerebral palsy (CP). The purpose of this study was to investigate the relationship between segmental control of the trunk and the corresponding gross motor function in children with CP. METHOD: This retrospective cross-sectional study was based on 92 consecutive referrals of children with CP in Gross Motor Function Classification System (GMFCS) levels I to V, 39 females, 53 males (median age 4y [range 1-14y]), and 77, 12, and 3 with spastic, dyskinetic, and ataxic CP respectively. The participants were tested using the Gross Motor Function Measure (GMFM), the Pediatric Evaluation of Disability Inventory (PEDI), and the Segmental Assessment of Trunk Control (SATCo). RESULTS: Linear regression analysis showed a positive relationship between the segmental level of trunk control and age, with both gross motor function and mobility. Segmental trunk control measured using the SATCo could explain between 38% and 40% of variation in GMFM and between 32% and 37% of variation in PEDI. INTERPRETATION: This study suggests a strong association between segmental trunk postural control and gross motor function and mobility with significant clinical implications for the treatment of children with CP.

Total knee arthroplasty in younger patients evaluated by alternative outcome measures.

In this prospective multicenter study we included subjects younger than 60 years of age and scheduled for primary total knee arthroplasty (TKA). The study assessed patients' overall satisfaction, fulfillment of preoperative expectations, the effect on socioeconomic parameters, and quality of sexual life. Questionnaires including Oxford Knee Score (OKS) and SF-36 were evaluated preoperatively and 3, 6, and 12 months postoperatively. OKS and SF-36 showed significant improvements. However, patient satisfaction and fulfillment of personal expectations did not reflect these scores. Overall, TKA did not affect the patients' socioeconomic status, and overall, patients did not experience impairment of sexual life, but decreased frequency and negative affection of sexual practice should be anticipated. Alternative outcome measurements of TKA surgery not focusing on implants and surgical techniques shed new light on important consequences of arthroplasty surgery.

Improved clinical status, quality of life, and walking capacity in Parkinson's disease after body weight-supported high-intensity locomotor training.

OBJECTIVE: To evaluate the effect of body weight-supported progressive high-intensity locomotor training in Parkinson's disease (PD) on (1) clinical status; (2) quality of life; and (3) gait capacity. DESIGN: Open-label, fixed sequence crossover study. SETTING: University motor control laboratory. PARTICIPANTS: Patients (N=13) with idiopathic PD (Hoehn and Yahr stage 2 or 3) and stable medication use. INTERVENTIONS: Patients completed an 8-week (3 × 1h/wk) training program on a lower-body positive-pressure treadmill. Body weight support was used to facilitate increased intensity and motor challenges during treadmill training. The training program contained combinations of (1) running and walking intervals, (2) the use of sudden changes (eg, in body weight support and speed), (3) different types of locomotion (eg, chassé, skipping, and jumps), and (4) sprints at 50 percent body weight. MAIN OUTCOME MEASURES: The Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Parkinson's Disease Questionnaire-39 items (PDQ-39), and the six-minute walk test were conducted 8 weeks before and pre- and posttraining. RESULTS: At the end of training, statistically significant improvements were found in all outcome measures compared with the control period. Total MDS-UPDRS score changed from (mean ± 1SD) 58±18 to 47±18, MDS-UPDRS motor part score changed from 35±10 to 29±12, PDQ-39 summary index score changed from 22±13 to 13±12, and the six-minute walking distance changed from 576±93 to 637±90m. CONCLUSIONS: Body weight-supported progressive high-intensity locomotor training is feasible and well tolerated by patients with PD. The training improved clinical status, quality of life, and gait capacity significantly.

The epidemiology of Schmorl's nodes and their correlation to radiographic degeneration in 4,151 subjects.

PURPOSE: Schmorl's nodes (SNs) are commonly seen in vertebral imaging of the normal adult population referred for different reasons and are duly noted by the radiologist. However, little is known about their etiology: either SNs are perceived as largely inert developmental or congenital herniations of disc tissue into weak areas of the vertebral end-plates, or they are perceived as a common pathological pathway of different adverse and general factors such as malignancy, trauma, infection, osteoporosis, Paget's disease and so forth. A commonly accepted morphological definition of what precisely constitute SNs does not exist, and consequently prevalences vary wildly in the literature. In the present study of 4,151 standardized lateral radiographs of the lumbar spine in an adult, Caucasian population between 22 and 93 years (median age 63 years, M 1,533, W 2,618). METHODS: We investigated prevalence, distribution and epidemiologic relationships of SNs. RESULTS: SNs occur primarily in the upper part of the lumbar spine, and usually there are multiple lesions in the same individual. We could not establish any significant correlation between SNs and gender, age, BMI, height, weight or occupational exposure for heavy lifting. The overall prevalence was 3.8%. We did not find any significant correlations between SNs and overall degeneration of the lumbar spine. CONCLUSION: We found a prevalence of SNs in the lower end of the spectrum than hitherto reported.

The alignment of the knee joint in relationship to age and osteoarthritis: the Copenhagen Osteoarthritis Study.

INTRODUCTION: The aim of the present study was to describe the changes in the axis of the knee joint in both radiologically osteoarthritic and non-osteoarthritic knees, on the basis of angles measurable in standardized clinical short knee radiographs, in a cross sectional study of an epidemiological cohort. DESIGN: From the third inclusion of the Copenhagen City Heart Study, 4,151 subjects were selected for standardized radiography of the knees. After censuring the inclusion, the resulting cohort was comprised of 3,488 individuals. Images were analyzed for radiological knee joint osteoarthritis (OA) and the anatomical femorotibial axis of the knee joint was measured. RESULTS: The prevalence of knee joint OA in males was 27.9% and 27.5%, for the left and right knees respectively. In females this was 32.8% and 36.4%. The mean knee joint angles were 4.11° in males; and 5.45° in females. A difference of 1.3° was found between the genders. In non-osteoarthritic knees the increase in valgus orientation in relationship to increasing age was found to be 0.03° and 0.04° per year, respectively, for males and females. Likewise, Kellgren and Lawrence found that OA was seen to influence a shift towards varus of 0.55°-0.76° per level of OA. CONCLUSION: Stratification in accordance with morphological severity of OA documented a clear tendency for the axis of the diseased knees to depart from the mean, primarily in the direction of varus. In knees exhibiting no signs of radiographic osteoarthritis we found a significant relationship between increasing age and a shift in the anatomical axis in the direction of valgus.

Case definitions of knee osteoarthritis in 4,151 unselected subjects: relevance for epidemiological studies: the Copenhagen Osteoarthritis Study.

INTRODUCTION: The aims of the present study were threefold: to examine the distribution of knee joint osteoarthritis in a large, standardized radiological study; to examine the relationships between self reported knee pain and radiological OA; and to examine the natural history of radio-morphological change over age in individuals without radiological features of OA. MATERIALS AND METHODS: The Copenhagen Osteoarthritis Study - COS is a substudy of the Copenhagen City Heart Study, a longitudinal regional health survey. From the third inclusion of the CCHS (1992-1994) 4,151 subjects were selected for subsequent standardized radiography of the pelvis, the knees, the hands, the wrists, and the lumbar spine. Images were analyzed and knee joint osteoarthritis (OA) was classified according to the radiographic atlas of Kellgren and Lawrence. Joint space width (JSW) was measured at three sites within both the medial and the lateral compartment. RESULTS: For the entire cohort the prevalence of radiological knee joint OA of all grades was 38.7% for men and 44.2% for women. Age stratification documented increasing knee joint OA both in regard to prevalence and morphological severity. Knee pain was universally correlated to the Kellgren and Lawrence severity of OA. In a subgroup with no features of radiological OA, a significant and linear decline in JSW with increasing age was found. CONCLUSION: We found a clear relationship between self-reported knee pain and radiological osteoarthritis. Pain was proportionally related to the severity of change. We also demonstrated a significant diminishing of joint space width with increasing age in individuals without apparent radiological degeneration.

Dorsiflexor muscle-group thickness in children with cerebral palsy: relation to cross-sectional area.

If the thickness and cross-sectional area of the dorsiflexor muscle group are related in children with cerebral palsy, measurements of muscle thickness may be used to monitor changes in muscle size due to training or immobilisation in these patients. We assessed the validity and reliability of measurements of dorsiflexor muscle-thickness using the cross-sectional area of the muscle group as the criterion-related muscle-size variable. Muscle thickness was measured using ultrasound, and cross-sectional area using MRI in nine children with spastic cerebral palsy (eight with hemiplegia). Test-retest reliability of the muscle-thickness measurements was assessed in six healthy subjects. All measurements were made on both legs at 35% lower leg length. In the children with cerebral palsy, dorsiflexor muscle-thickness and cross-sectional area were well correlated (r(2) = 0.778, P < 0.001), and the reliability of the muscle-thickness measurements was high in the healthy subjects (ICC(2.1) = 0.94, standard error of measurement = 0.04 cm). The dorsiflexor muscle-thickness was 22% less in the affected compared to the non-affected leg in children with hemiplegic cerebral palsy (P < 0.001). Accordingly, the dorsiflexor cross-sectional area was 32% less in the affected compared to the non-affected leg (P = 0.002). Measurements of dorsiflexor muscle-thickness can be reliably obtained, and they reflect dorsiflexor cross-sectional area in children with cerebral palsy.

The functional effect of segmental trunk and head control training in moderate-to-severe cerebral palsy: A randomized controlled trial.

PURPOSE: To determine whether segmental training is more effective in improving gross motor function in children and young people with moderate-to-severe cerebral palsy than conventional physiotherapy. METHODS: Twenty-eight participants were randomized to a segmental training or control group. Outcomes were Gross Motor Function Measure (GMFM), Pediatric Evaluation of Disability Inventory (PEDI), Segmental Assessment of Trunk Control (SATCo), and postural sway at baseline, at primary endpoint (6 months), and at follow-up (12 months). RESULTS: There were no significant differences in either GMFM, PEDI, or SATCo scores at primary endpoint or follow-up. There were significant reductions in anterior-posterior head angular sway and trunk sway in the segmental training group at primary endpoint but not at follow-up. CONCLUSION: Segmental training was not superior to usual care in improving GMFM. Improvements in head and trunk sway were greater in the segmental training group at primary endpoint but not at follow-up.

Low bone mineral density is associated with reduced hip joint space width in women: results from the Copenhagen Osteoarthritis Study.

OBJECTIVE: Since estrogen receptors (ER-alpha/ER-beta) were identified in human chondrocytes, animal and experimental studies have demonstrated the importance of continued estrogen production for the integrity of articular cartilage. However, human epidemiological support of the hypothesis has been inconclusive. The present cross-sectional study investigated the relationship between reduced bone mineral density (BMD), as a surrogate parameter of endogenous estrogen status assessed by digital x-ray radiogrammetry, and reduced minimum hip joint space width (JSW). DESIGN: Standardized hand radiographs of the Copenhagen Osteoarthritis Study cohort of 3,913 adults (1,470 male/2,443 female) with a mean age of 60 years (range, 18-92) were analyzed using X-Posure digital software, version 2.0 (Sectra-Pronosco). The system is operator independent. From 1,200 individual measurements per radiograph, mean BMD was calculated. Minimum hip JSW was assessed on standardized pelvic radiographs. RESULTS: Digital x-ray radiogrammetry BMD decreased in both men and women after the age of 45 years, progressively more so in women. Although minimum hip JSW in men remained relatively unaltered throughout life, a marked decline in female minimum hip JSW after age 45 years was observed. We found moderate but highly significant relationships between reduced BMD and reduced hip JSW in women (P < 0.0001), adjusted for age and dysplastic joint incongruity. CONCLUSION: We believe that the present study supports the hypothetical relationship between reduced estrogen levels and hip JSW reduction in women.

Integrity of the lateral femoral wall in intertrochanteric hip fractures: an important predictor of a reoperation.

BACKGROUND: Reoperations after intertrochanteric fractures are often necessitated by fracture displacement following mobilization of the patient. The biomechanical complexity of the fracture, the position of the implant, and the patient's characteristics are known to influence postoperative outcome. We investigated the importance of an intact lateral femoral wall as a factor in postoperative fracture displacement after fixation with a sliding compression hip screw. METHODS: Two hundred and fourteen consecutive patients with an intertrochanteric fracture were treated with a 135 degrees sliding compression hip screw with a four-hole side-plate between 2002 and 2004. The fractures were classified on preoperative radiographs according to the AO/OTA classification system. The status of the greater and lesser trochanters, the integrity of the lateral femoral wall, and the position of the implant were assessed postoperatively. Reoperations due to technical failure were recorded for six months postoperatively. RESULTS: Only 3% (five) of 168 patients with an intact lateral femoral wall postoperatively underwent a reoperation within six months, whereas 22% (ten) of forty-six patients with a fractured lateral femoral wall were operated on again (p < 0.001). Multivariate logistic regression analyses combining demographic and biomechanical parameters showed a compromised lateral femoral wall to be a significant predictor of a reoperation (p = 0.010). Seventy-four percent (thirty-four) of the forty-six fractures of the lateral femoral wall occurred during the operative procedure itself. A fracture of the lateral femoral wall occurred in only 3% (three) of the 103 patients with an AO/OTA type-31-A1.1, A1.2, A1.3, or A2.1 intertrochanteric fracture compared with 31% (thirty-one) of the ninety-nine with an AO/OTA type 31-A2.2 or A2.3 fracture (p < 0.001). CONCLUSIONS: A postoperative fracture of the lateral femoral wall was found to be the main predictor for a reoperation after an intertrochanteric fracture. Consequently, we concluded that patients with preoperative or intraoperative fracture of the lateral femoral wall are not treated adequately with a sliding compression hip-screw device, and intertrochanteric fractures should therefore be classified according to the integrity of the lateral femoral wall, especially in randomized trials comparing fracture implants.

Calf muscle volume estimates: implications for botulinum toxin treatment?

An optimal botulinum toxin dose may be related to the volume of the targeted muscle. We investigated the suitability of using ultrasound and anthropometry to estimate gastrocnemius and soleus muscle volume. Gastrocnemius and soleus muscle thickness was measured in 11 cadaveric human legs, using ultrasound. Lower leg length was tape-measured. Muscle volume was determined by water displacement of the dissected muscles. Simple and multiple regression analyses, using muscle thickness and lower leg length as independent variables, were performed to establish muscle volume prediction equations from the muscle volume measured by water displacement. Validating the equations based on simple regression analyses resulted in a correlation (r2) of 0.373 and 0.518 (P < 0.047), and a standard error of the estimate of 24.4 cm3 (11.7% of the measured mean muscle volume) and 33.2 cm3 (12.7%) for the gastrocnemius and soleus muscles, respectively. The corresponding values for the multiple regression analyses were an r2 of 0.497 and 0.650 (P < 0.017), and a standard error of the estimate of 21.9 cm3 (10.5%) and 28.4 cm3 (10.8%) for the gastrocnemius and soleus muscles, respectively. It seems possible to estimate the volume of individual plantar flexor muscles using ultrasound and anthropometry. This possibility should be investigated further in living humans.

The role of the paravertebral muscles in adolescent idiopathic scoliosis evaluated by temporary paralysis.

BACKGROUND: Muscle imbalance has been suggested as implicated in the pathology of adolescent idiopathic scoliosis (AIS). The specific "pathomechanic" role of the paravertebral muscles as being scoliogenic (inducing scoliosis) or counteracting scoliosis in the initial development and maintenance of this spinal deformity has yet to be clarified in humans. In the present study, we investigated the radiographic changes of temporal paralysis using botulinum toxin A as localized injection therapy (ITB) in the psoas major muscle in AIS patients. METHODS: Nine patients with AIS were injected one time with ITB using ultrasonic and EMG guidance in the selected spine muscles. Radiographic and clinical examinations were performed before and 6 weeks after the injection. Primary outcome parameters of radiological changes were analyzed using Wilcoxon signed-rank test and binomial test, and secondary outcome parameters of short- and long-term clinical effects were obtained. RESULTS: Significant radiological corrective changes were seen in the frontal plane in the thoracic and lumbar spine as well as significant derotational corrective change in the lumbar spine according to Cobb's angle measurements and to Nash and Moe's classification, respectively. No serious adverse events were detected at follow-up. CONCLUSIONS: In conclusion, this study demonstrated that the psoas major muscle do play a role into the pathology in adolescent idiopathic scoliosis by maintaining the curvature of the lumbar spine and thoracic spine. TRIAL REGISTRATION: EudraCT number 2008-004584-19.

External otitis caused by infection with Pseudomonas aeruginosa or Candida albicans cured by use of a topical group III steroid, without any antibiotics.

CONCLUSIONS: Irrespective of the microbial agent, group III steroid solution cured external otitis efficiently in a rat model. The addition of antibiotic components to steroid solutions for the treatment of external otitis is of questionable validity. OBJECTIVE: External otitis, caused by infection with either Pseudomonas aeruginosa or Candida albicans, was established in a rat model and the treatment efficacy of a group III steroid solution was studied. MATERIAL AND METHODS: Three treatments were studied: (i) a group III steroid solution; (ii) a group I steroid combined with two antibiotic components; and (iii) a saline solution. A scoring scale was used to evaluate the characteristics of the ear canal skin. Bacteriological and fungal samples were collected for culturing and ear canal skin biopsies were taken for structural analyses. RESULTS: It was possible to cause P. aeruginosa and C. albicans infections in an animal model. In the P. aeruginosa-infected animals, only the group III steroid treatment cured all the animals. In the C. albicans-infected animals, group III steroid treatment resolved external otitis faster than the other treatment modalities.

High Diagnostic Accuracy of Nitrite Test Paired with Urine Sediment can Reduce Unnecessary Antibiotic Therapy.

BACKGROUND: Urinary tract infections (UTIs) are common bacterial infections dominated by lower UTI in women (LUTIW). Symptoms only are insufficient for diagnosis and accordingly, near patient diagnostic tests confidently confirming significant bacteriuria are desirable. The nitrite test (NIT) has low sensitivity, while bacterial and leukocyte counts disjunctively paired in urine sediment microscopy (SED) have high sensitivity. Similar symptomatic cure rates are found post antibiotic vs. placebo therapy in patients with negative cultures. Consequently, prescription on symptoms only implies unnecessary antibiotic therapy. AIMS: to evaluate the diagnostic outcomes of NIT, SED and NIT disjunctively paired with SED (NIT+SED) vs. urine culture, with special focus on bladder incubation time (BIT), and to assess if NIT+SED can reduce unnecessary antibiotic therapy. METHODS: A diagnostic, primary care, multicentre study including 1070 women with symptoms suggestive of lower UTI. RESULTS: Significant bacteriuria was found in 77%. The BIT highly influenced the diagnostic outcomes and the optimal duration was ≥4h with sensitivity of 66, 90 and 95% for NIT, SED and NIT+SED, respectively. SED performed only in NIT negative specimens could reduce unnecessary antibiotics by 10% vs. prescription on symptoms only. The number needed to test with SED to reduce one unnecessary antibiotic course was five patients at BIT ≥4h and six patients at ≤3h or overall. CONCLUSION: The BIT highly influences the diagnostic outcomes with the highest accuracy of NIT+SED. Diagnosis of LUTIW with NIT+SED can reduce unnecessary antibiotic therapy and subsequently decrease antimicrobial resistance. TRIAL REGISTRATION: The Swedish Medical Product Agency 1995 03 01:151:01783/94.

Alternative outcome measures in young total hip arthroplasty patients: a prospective cohort study.

In this prospective multicentre cohort study we studied subjects younger than 60 years of age scheduled for primary total hip arthroplasty (THA). The study assessed patients' overall satisfaction, fulfillment of preoperative expectations, the effect on socioeconomic parameters, and quality of sex-life. Questionnaires including Oxford Hip Score (OHS) and SF-36 were evaluated preoperatively and 3, 6 and 12 months postoperatively. OHS and SF-36 showed significant improvements (p<0.028, Wilcoxon Signed Rank test). THA did not affect the patients' socioeconomic status. Increased frequency of intercourse or better abilities in intercourse positions were experienced by 18 of 39 females due to reduced pain and increased range of motion. Patients sexually active before THA surgery remained active. These findings constitute important new information to young patients and surgeons during the decision making process.

High Cytokine Levels in Tonsillitis Secretions Regardless of Presence of Beta-Hemolytic Streptococci.

Acute pharyngotonsillitis denotes tonsillar inflammation caused by bacteria or viruses. Here, we investigated if beta-hemolytic streptococci (ß-HS) tonsillitis would differ in inflammatory mediator response from tonsillitis of other causes. Tonsillar secretions were obtained from 36 acute pharyngotonsillitis patients and 16 controls. Bacteria were cultured quantitatively and 18 different viruses were quantified by real-time polymerase chain reaction. Cytokine and prostaglandin E2 (PGE2) levels were determined by enzyme-linked immunosorbent assays. Almost half of the patients' tonsillar secretions yielded high counts of ß-HS, and most samples contained viruses, irrespective of whether ß-HS were present or not. The Epstein-Barr virus (EBV) was the most common virus (patients 62% and controls 13%). Compared to controls, patients' secretions had higher levels of interleukin (IL)-1ß, IL-6, IL-8, tumor necrosis factor (TNF), and PGE2, while few samples contained IL-12, IL-10, or interferon-gamma (IFN-γ). The presence of ß-HS in tonsillitis secretions could not be distinguished by any of the measured mediators, while the presence of EBV DNA tended to be associated with enhanced levels of IL-1ß and IL-8. The results suggest a common inflammatory response in acute pharyngotonsillitis, regardless of causative agent. The suggested correlation between intense inflammation and the presence of EBV DNA in tonsillitis secretions may be due to reactivation of the virus and/or the EBV-containing B cells.

The Effect of Botulinum Toxin A Injections in the Spine Muscles for Cerebral Palsy Scoliosis, Examined in a Prospective, Randomized Triple-blinded Study.

STUDY DESIGN: A prospective, randomized triple-blinded cross-over design treating with either botulinum toxin A (BXT) or saline (NaCl). OBJECTIVE: To examine the efficacy of BTX treatment in cerebral palsy scoliosis (CPS). SUMMARY OF BACKGROUND DATA: Intramuscular injections with BTX have been used off label in treating CPS. 1 prospective study has been conducted, demonstrating in both radiological and clinical improvement, whereas showing no side effects or complications. METHODS: Subjects (brace-treated CPS between 2 and 18 yr) were injected using ultrasonic-guidance with either NaCl or BTX in selected spine muscles with 6 mo intervals (block randomization, sealed envelope). Radiographs of the spine and clinical follow-up were captured before and 6 weeks after each injection. Primary outcome parameter was radiological change in Cobb angle, where a 7° change was regarded as an effect (1 SD). Radiological parameters were measured before and 6 weeks after treatment by 3 experienced doctors separately. Moreover, clinical results were evaluated by the pediatric quality of life score and systematic open questioning of the parents about the child's wellbeing. Subjects, researchers, and monitors were blinded during the trial. Appropriate permissions (2008-004584-19) and no funding were obtained. RESULTS: 16 cerebral palsy patients (GFMCS III-V) with CPS were consecutively included, whereas 6 patients were excluded. There were no drop-outs to follow-up, but 1 possible serious adverse event of pneumonia resulting in death was recorded and the study was terminated. No significant radiological or clinical changes were detected when compared with NaCl injections using Wilcoxon matched pair signed-rank test. CONCLUSION: No positive radiological or clinical effects were demonstrated by this treatment, except for the parent's initial subjective but positive appraisal of the effect. However, the study was terminated due to 1 possible severe adverse event and scheduled numbers needed to treat (hence power) were not reached. LEVEL OF EVIDENCE: 1.