Long-term safety and efficacy of open-label nabilone on sleep and pain in Parkinson´s Disease.

The synthetic tetrahydrocannabinol-analog nabilone improved non-motor symptoms (NMS) in Parkinson's disease (PD) patients in a placebo-controlled, double-blind, parallel-group, randomized withdrawal trial with enriched enrollment (NMS-Nab-study). This was a single-center open-label extension study to assess the long-term safety and efficacy of nabilone for NMS in PD. To be eligible for this study, patients had to be treatment responders during the previous NMS-Nab-trial and complete its double-blind phase without experiencing a drug-related serious/severe/moderate adverse event (AE). Patients were re-introduced to nabilone during an up-titration phase until their overall NMS burden improved. Nabilone was continued for six months with clinic visits every 3 months. Evaluation of AEs was based on self-report and clinical assessment. Twenty-two patients participated in the NMS-Nab2-study (age-median 68.33 y, 52% females, disease duration-median 7.42 y). Nabilone was well tolerated with concentration difficulties as the most common treatment-related AE (possibly/not related n = 1 each). One in two drop-outs discontinued because of an AE for which a prohibited concomitant medication needed to be introduced (night-time sleep problems). Efficacy evaluation showed a significant and lasting improvement in NMS burden according to the CGI-I (79% at V3). Nabilone improved overall sleep (NMSS Domain-2: -8.26 points; 95%CI -13.82 to -2.71; p = 0.004; ES = -0.72), night-time sleep problems (MDS-UPDRS-1.7: -1.42 points; 95 CI -2.16 to -0.68; p = 0.002; ES = -0.92), and overall pain (KPPS Total Score: -8.00 points; 95%CI -15.05 to -0.95; p = 0.046; ES -0.55 and MDS-UPDRS-1.9: -0.74 points; 95%CI -1.21 to -0.26; p = 0.008; ES = -0.74). This study demonstrates continuous long-term safety and efficacy in PD patients responding early to nabilone without intolerable side effects.

Effects of Nabilone on Sleep Outcomes in Patients with Parkinson's Disease: A Post-hoc Analysis of NMS-Nab Study.

Background: The synthetic tetrahydrocannabinol analogue nabilone improved overall non-motor symptom (NMS) burden in Parkinson's disease (PD) patients in comparison to placebo. Objectives: To characterize the effects of nabilone on different sleep outcomes in PD patients. Methods: We performed a post-hoc analysis of the controlled, double-blind, enriched enrollment randomized withdrawal NMS-Nab study to assess the effects of nabilone on sleep outcomes in study participants who reported clinically-relevant sleep problems (MDS-UPDRS-1.7 ≥ 2 points). Results: After open-label nabilone administration, 77.4% reported no relevant sleep problem. In the withdrawal phase of the trial, the MDS-UPDRS-1.7. and the NMS-Scale Domain 2 (i.e., Sleep/Fatigue) significantly worsened only in PD patients in the placebo group, which was mostly driven by a significant worsening of insomnia (question 5 of the NMS-Scale Domain 2). Conclusions: This post-hoc analysis of the NMS-Nab trial suggests that nabilone has beneficial effects on sleep outcomes in PD patients experiencing sleep problems at baseline.The original trial was registered with ClinicalTrials.gov (NCT03769896, https://clinicaltrials.gov/ct2/show/NCT03769896) and EudraCT (2017-000192-86).

On the recovery of disorders of consciousness under intrathecal baclofen administration for severe spasticity-An observational study.

BACKGROUND: Occasionally, patients show dramatic recovery from disorders of consciousness (DOC) under intrathecal baclofen (ITB), an established treatment option for severe supraspinal spasticity. Anecdotal explanations for ITB-related recovery of cognition include modulation of afferent impulses at the spinal level, thereby reducing spasticity-related proprioceptive information overload within cortico-thalamo-cortical connections. OBJECTIVE: In this retrospective patient chart analysis, we assessed whether a reduction in spasticity would be associated with an increase in Coma Recovery Scale revised (CRS-R) scores in a larger sample of patients than previously published. METHODS: From a hospital-based ITB treatment register, we extracted data from 26 patients with DOC and severe supraspinal spasticity who improved by >2 points on the Coma Recovery Scale revised (CRS-R) within 6 months after ITB treatment initiation. We assessed Modified Ashworth scale (MAS) scores and CRS-R scores on admission (PRE) and 3 and 6 months after initiation of ITB treatment (3M, 6M). We performed correlation analysis of the scores and their respective changes (PRE to 3M, 3M to 6M). We also correlated the time from acute event until ITB initiation to CRS-R scores at 3M and 6M. RESULTS: ITB led to significant improvement in spasticity based on MAS scores, which did not correlate to the improvements seen in CRS-R total and subscale scores. Daily ITB dose did neither correlate to MAS scores nor to CRS-total scores in the whole patient group, but after 3 months, ITB dose correlated to some CRS-R subscale scores in some patient subgroups. Time until ITB treatment did not correlate to CRS-R scores later on. CONCLUSIONS: Our data confirm that ITB may exert beneficial effects in selected DOC patients with respect to improved cognitive functions, which, however, do not correlate to its antispastic effect. The lack of correlation between time to ITB and CRS-R outcome, but significant CRS-R improvements following pump implantation, renders spontaneous remissions unlikely and leaves room for alternative pharmacological mechanisms.

Undetected ophthalmological disorders in Parkinson's disease.

BACKGROUND: Ophthalmological disorders are common and frequently disabling for people with Parkinson's disease (PD). However, details on the prevalence, severity and impact of ophthalmological disorders thus far lacking. We aimed to identify PD patients with undetected ophthalmological disorders in a large cross-sectional, observational study. METHODS: We previously delivered a screening questionnaire to detect ophthalmological symptoms (Visual impairment in PD questionnaire; VIPD-Q) to 848 patients. Here, we report on a subgroup of 102 patients who received complete ophthalmological assessment aimed at identifying clinically relevant ophthalmological diseases, which were classified as either vison-threatening or not. Impact on daily life functioning was measured using the visual functioning-25 questionnaire (VFQ-25) and fall frequency. RESULTS: Almost all patients (92%) had one or more clinically relevant ophthalmological disorders. Of those, 77% had a potentially vision-threatening disease, while 34% had a potentially treatable ophthalmological disease which impacted on quality of life. The most prevalent ophthalmological disorders were dry eyes (86%), ocular misalignment (50%) and convergence insufficiency (41%). We found a weak but significant association between clinically relevant ophthalmological diseases and both fall frequency (R2 = 0.15, p = 0.037) and VFQ-25 score (R2 = 0.15, p = 0.02). The VIPD-Q could not correctly identify patients with relevant ophthalmological disorders. CONCLUSIONS: Surprisingly, in our study sample, many participants manifested previously undetected ophthalmological diseases, most of which threatened vision, impacted on daily life functioning and were amenable to treatment. Screening for these ophthalmological disorders using a questionnaire asking about symptoms seems insufficient. Instead, episodic ophthalmological assessments should be considered for PD patients, aiming to identify vision-threatening yet treatable diseases. TRIAL REGISTRATION: Dutch Trial Registration, NL7421.

Prodromal Parkinson's disease: hype or hope for disease-modification trials?

The ultimate goal in Parkinson's disease (PD) research remains the identification of treatments that are capable of slowing or even halting the progression of the disease. The failure of numerous past disease-modification trials in PD has been attributed to a variety of factors related not only to choosing wrong interventions, but also to using inadequate trial designs and target populations. In patients with clinically established PD, neuronal pathology may already have advanced too far to be modified by any intervention. Based on such reasoning, individuals in yet prediagnostic or prodromal disease stages, may provide a window of opportunity to test disease-modifying strategies. There is now sufficient evidence from prospective studies to define diagnostic criteria for prodromal PD and several approaches have been studied in observational cohorts. These include the use of PD-risk algorithms derived from multiple established risk factors for disease as well as follow-up of cohorts with single defined prodromal markers like hyposmia, rapid eye movement sleep behavior disorders, or PD gene carriers. In this review, we discuss recruitment strategies for disease-modification trials in various prodromal PD cohorts, as well as potential trial designs, required trial durations, and estimated sample sizes. We offer a concluding outlook on how the goal of implementing disease-modification trials in prodromal cohorts might be achieved in the future.

Rapid eye movement sleep behavior disorder and rapid eye movement sleep without atonia are more frequent in advanced versus early Parkinson's disease.

STUDY OBJECTIVES: To evaluate macro sleep architecture and characterize rapid eye movement (REM) sleep without atonia (RWA) by using the SINBAR excessive electromyographic (EMG) montage including mentalis and upper extremity muscles in early and advanced Parkinson's disease (PD). METHODS: We recruited 30 patients with early- and advanced-stage of PD according to Movement Disorder Society (MDS) Clinical Diagnostic Criteria. Participants were classified as early-stage PD if they were treatment-naïve or had no motor complications and had been diagnosed with PD within the previous 6 years. Advanced PD was defined as a disease duration equal to or >6 years with or without motor complications. RESULTS: There was significantly shorter REM sleep latency in early as compared to the advanced stage of PD. We found that the sleep Innsbruck Barcelona (SINBAR) EMG index and tonic EMG activity of the mentalis muscle in advanced-stage PD were significantly higher than in early-stage PD with a trend in phasic EMG activity of the flexor digitorum superficialis muscles. The SINBAR EMG index, tonic and any EMG activity of the mentalis muscle, and phasic EMG activity of flexor digitorum superficialis muscles significantly correlated with disease duration. CONCLUSIONS: This study analyzed RWA using the SINBAR EMG montage in early- and advanced-stage of PD and showed higher RWA in mentalis and flexor digitorum superficialis muscles and SINBAR EMG index in advanced-PD patients compared to patients in the early stage. Also, polysomnography-confirmed REM sleep behavior disorder was more common in advanced versus early-stage patients. Our findings suggest that RWA worsens or is more intense or more frequent with disease progression.

Has Deep Brain Stimulation Changed the Very Long-Term Outcome of Parkinson's Disease? A Controlled Longitudinal Study.

BACKGROUND: The long-term impact of deep brain stimulation (DBS) on Parkinson's disease (PD) is difficult to assess and has not yet been rigorously evaluated in comparison to its natural history. OBJECTIVE: Comparison of key disability milestones (recurrent falls, psychosis, dementia, and institutionalization) and death in patients with PD with versus without DBS. METHODS: We collected retrospective information from clinical notes of patients with PD at our center that were implanted with subthalamic DBS >8 years ago (1999-2010) and a control group of PD patients without DBS similar in age at onset, age at baseline, sex distribution, and number of comorbidities at baseline (extracted from a registry study performed in 2004). Cox regression models were used to calculate hazard ratios, adjusted for potential baseline confounding variables (age, sex, disease duration, disease severity, and number of comorbidities). RESULTS: A total of 74 DBS-treated and 61 control patients with PD were included. For a median observational period of 14 years, patients treated with DBS were at lower risk of experiencing recurrent falls (hazard ratio = 0.57; 95% confidence interval, 0.37-0.90; P = 0.015) and psychosis (hazard ratio = 0.26; 95% confidence interval, 0.12-0.59; P = 0.001) compared with control patients. There was no significant difference in risk for dementia, institutionalization, or death. Disease progression as assessed by Hoehn and Yahr scores was not slower in DBS-treated patients. CONCLUSIONS: Treatment with chronic subthalamic DBS was associated with lower risk for recurrent falls and psychotic symptoms, effects that may be mediated through improved motor symptom control and reduction in dopaminergic therapies, respectively. There was no evidence for DBS effects on underlying disease progression.

Non-Motor Symptoms in Parkinson's Disease are Reduced by Nabilone.

OBJECTIVE: The objective of this study was to assess the efficacy and safety of nabilone, a synthetic tetrahydrocannabinol analogue, as a treatment for non-motor symptoms (NMS) in Parkinson's disease (PD). METHODS: This was a phase II placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal trial conducted at the Medical University Innsbruck. A random sample of 47 patients with PD with stable motor disease and disturbing NMS defined by a score of ≥4 points on the Movement Disorder Society - Unified PD Rating Scale-I (MDS-UPDRS-I) underwent open-label nabilone titration (0.25 mg once daily to 1 mg twice daily, phase I). Responders were randomized 1:1 to continue with nabilone or switch to placebo for 4 weeks (phase II). The primary efficacy criterion was the change of the MDS-UPDRS-I between randomization and week 4. Safety was analyzed in all patients who received at least one nabilone dose. RESULTS: Between October 2017 and July 2019, 19 patients received either nabilone (median dose = 0.75 mg) or placebo. At week 4, mean change of the MDS-UPDRS-I was 2.63 (95% confidence interval [CI] 1.53 to 3.74, p = 0.002, effect size = 1.15) in the placebo versus 1.00 (95% CI -0.16 to 2.16, p = 0.280, effect size = 0.42) in the nabilone-group (difference: 1.63, 95% CI 0.09 to 3.18, p = 0.030, effect size = 0.66). Seventy-seven percent of patients had adverse events (AEs) during open-label titration, most of them were transient. In the double-blind phase, similar proportions of patients in each group had AEs (42% in the placebo group and 32% in the nabilone group). There were no serious AEs. INTERPRETATION: Our results highlight the potential efficacy of nabilone for patients with PD with disturbing NMS, which appears to be driven by positive effects on anxious mood and night-time sleep problems. TRIAL REGISTRY: ClinicalTrials.gov (NCT03769896) and EudraCT (2017-000192-86). ANN NEUROL 2020;88:712-722.

Augmentation in restless legs syndrome: an eye tracking study on emotion processing.

OBJECTIVE: To assess emotional processing and alexithymia in patients with restless legs syndrome (RLS) with augmentation versus those who never had augmentation. METHODS: We recruited 26 patients who had a history of augmentation (AUG), either current or past, 27 RLS patients treated with dopamine agonists who never had augmentation (RLS controls), and 21 healthy controls (HC). All participants were screened for impulse control disorders (ICDs). Alexithymia was assessed by means of the Toronto Alexithymia Scale - 20 (TAS-20). Facial emotion recognition was tested through an eye-tracking task. Furthermore, all participants performed neuropsychological tests assessing global cognitive status, impulsivity, anxiety, and depression. RESULTS: ICD symptoms occurred more frequently in AUG patients than in RLS controls (P = 0.047). Patients with AUG scored higher on the TAS-20 (P = 0.007) and the attentional subdomain of an impulsivity scale (BIS-11; P = 0.015) compared to HC. Patients with AUG also performed worse on the facial emotion recognition task relative to RLS controls (P = 0.009) and HC (P = 0.003). We found a group difference for the time to first fixation and the fixation count in the mouth region (P = 0.019 and P = 0.021, respectively). There were no other differences in the eye tracking examination. INTERPRETATION: This study showed evidence of poorer emotional processing in patients who had augmentation compared to RLS patients without augmentation and healthy controls. The altered exploration pattern of faces and the higher alexithymia scores suggest abnormalities in emotion processing in patients with augmentation.

Seeing ophthalmologic problems in Parkinson disease: Results of a visual impairment questionnaire.

OBJECTIVE: To determine the prevalence and clinical effect of ophthalmologic symptoms in patients with Parkinson disease (PD), compared with controls, using a standardized questionnaire. METHODS: In this observational, cross-sectional, multicenter study, 848 patients with PD and 250 healthy controls completed the Visual Impairment in Parkinson's Disease Questionnaire (VIPD-Q). The VIPD-Q addressed 4 domains according to structures: (1) ocular surface; (2) intraocular; (3) oculomotor; and (4) optic nerve. The questionnaire also assessed the effect of ophthalmologic symptoms on daily activities. RESULTS: One or more ophthalmologic symptoms were reported by 82% (95% confidence interval [CI], 80-85) of patients, compared with 48% (95% CI, 42-54) of controls (p < 0.001). Patients with PD experienced more ophthalmologic symptoms across all domains than controls (p < 0.001), as reflected by a higher VIPD-Q total score among patients (median 10 [interquartile range (IQR) 13]) than controls (median 2 [IQR 5]; p < 0.001). Ophthalmologic symptoms interfered with daily activities in 68% (95% CI, 65-71) of patients, compared with 35% (95% CI, 29-41) of controls (p < 0.001). CONCLUSION: Patients with PD have a higher prevalence of ophthalmologic symptoms than controls. Moreover, these frequently interfere with daily activities. A screening questionnaire such as the VIPD-Q may help with identifying ophthalmologic symptoms in PD, thereby enabling more timely treatment.

Towards seeing the visual impairments in Parkinson's disease: protocol for a multicentre observational, cross-sectional study.

BACKGROUND: Visual disorders are common in Parkinson's disease (PD) but their exact frequency and severity are unknown. Good visual functioning is crucial for patients with PD, because of their need to compensate for loss of automated motor control and their postural instability, forcing patients to guide their movements visually. Here, we describe the study design of a cross-sectional, multi-centre study aiming to: (1) validate the Visual Impairment screening questionnaire (VIPD-Q, which aims to identify PD patients who should be referred to an ophthalmologist for further assessment); (2) study the prevalence of visual disorders in PD; (3) study the severity and clinical impact of different types of visual disorders in PD; and (4) explore treatment options for ophthalmologic disorders in PD, as a basis for future guideline development. METHODS: This study consists of two phases. In phase one, 750 PD patients and 250 healthy controls will be recruited to complete the VIPD-Q. In phase two, a subgroup of responders (n = 100) (with the highest and lowest scores on the VIPD-Q) will be invited for an extensive neurological and ophthalmological assessment. The in-depth ophthalmologic examination will serve as the "gold standard" for validating the VIPD-Q. Moreover, these assessments will be used to study associations between visual disorders and clinical presentation, in order to gain more insight in their clinical impact. DISCUSSION: Our study will heighten the awareness of visual problems in PD and offers a robust starting point to systematically approach this subject. In current daily practice, the association between visual problems and PD is far from obvious to both patients and clinicians. Consequently, patients may not adequately report visual problems themselves, while clinicians miss potentially treatable visual disorders. Routinely asking patients to complete a simple screening questionnaire could be an easy solution leading to timely identification of visual problems, tailored treatment, restored mobility, greater independence and improved quality of life. TRIAL REGISTRATION: Dutch Trial Registration, NL7421 , Registered on 4 December 2018 - Retrospectively registered.

Nabilone for non-motor symptoms of Parkinson's disease: a randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study (The NMS-Nab Study).

Although open-label observations report a positive effect of cannabinoids on non-motor symptoms (NMS) in Parkinson's disease (PD) patients, these effects remain to be investigated in a controlled trial for a broader use in NMS in PD patients. Therefore, we decided to design a proof-of-concept study to assess the synthetic cannabinoid nabilone for the treatment of NMS. We hypothesize that nabilone will improve NMS in patients with PD and have a favorable safety profile. The NMS-Nab Study is as a mono-centric phase II, randomized, placebo-controlled, double-blind, parallel-group, enriched enrollment withdrawal study. The primary efficacy criterion will be the change in Movement Disorders Society-Unified Parkinson's Disease-Rating Scale Part I score between baseline (i.e. randomization) and week 4. A total of 38 patients will have 80% power to detect a probability of 0.231 that an observation in the treatment group is less than an observation in the placebo group using a Wilcoxon rank-sum test with a 0.050 two-sided significance level assuming a true difference of 2.5 points between nabilone and placebo in the primary outcome measure and a standard deviation of the change of 2.4 points. The reduction of harm through an ineffective treatment, the possibility of individualized dosing, the reduction of sample size, and the possible evaluation of the influence of the placebo effect on efficacy outcomes justify this design for a single-centered placebo-controlled investigator-initiated trial of nabilone. This study should be the basis for further evaluations of long-term efficacy and safety of the use of cannabinoids in PD patients.

Prevalence and Associated Factors of Sarcopenia and Frailty in Parkinson's Disease: A Cross-Sectional Study.

BACKGROUND: Sarcopenia and frailty are found in up to one-third of the general elderly population. Both are associated with major adverse health outcomes such as nursing home placement, disability, decreased quality of life, and death. Data on the frequency of both syndromes in Parkinson's disease (PD), however, are very limited. OBJECTIVE: We aimed to screen for sarcopenia and frailty in PD patients and to assess potential associations of both geriatric syndromes with demographic and clinical parameters as well as quality of life. METHODS: In this observational, cross-sectional study, we included 104 PD patients from a tertiary center and 330 non-PD controls from a population-based cohort aged > 65 years. All groups were screened for sarcopenia using the SARC-F score and for frailty using the Clinical Frailty Scale of the Canadian Study of Health and Aging (CSHA CFS). Prevalence rates of sarcopenia and frailty were also assessed in 18 PD patients from a population-based cohort aged > 65 years. Moreover, PD patients from the tertiary center were evaluated for motor and non-motor symptoms, quality of life, and dependency. RESULTS: The prevalence of sarcopenia was 55.8% (95% CI: 46.2-64.9%) in PD patients from the tertiary center and 8.2% (5.7-11.7%; p < 0.001) in non-PD controls. Frailty was detected in 35.6% (27.0-45.2%) and 5.2% (3.2-8.1%; p < 0.001). Prevalence rates for sarcopenia and frailty were 33.3% (16.1-56.4%; p = 0.004) and 22.2% (8.5-45.8%; p = 0.017) in the community-based PD sample. Both sarcopenia and frailty were significantly associated with longer disease duration, higher motor impairment, higher Hoehn and Yahr stages, decreased quality of life, higher frequency of falls, a higher non-motor symptom burden, institutionalization, and higher care levels in PD patients from a tertiary center compared to not affected PD patients (all p < 0.05). CONCLUSIONS: Both frailty and sarcopenia are more common in PD patients than in the general community and are associated with a more adverse course of the disease. Future studies should look into underlying risk factors for the occurrence of sarcopenia and frailty in PD patients and into adequate management to prevent and mitigate them.

Rate of surgery in a sample of patients fulfilling the SRS inclusion criteria treated with a Chêneau brace of actual standard.

UNLABELLED: Studies investigating the outcome of conservative scoliosis treatment differ widely with respect to the inclusion criteria used. Prospective cohort studies are available using the SRS inclusion criteria for studies on bracing. This seems to provide a great advantage to compare different strategies of bracing against each other. As we have gathered all data of the patients treated with a Chêneau light TM between June 2005 and November 2007 it was possible to identify the sample of patients fulfilling the SRS inclusion criteria from the whole sample. MATERIALS AND METHODS: 34 patients (of 152) fulfilled the SRS inclusion criteria with an average age of 12.06 years (10 - 13 years), average Cobb angle of 31 degrees (25 - 40°), an average Risser stage of 0,35, average in-brace Cobb angle of 13° (= 59% of in-brace correction). There were 17 thoracic, 10 double major, 6 lumbar and 2 thoracolumbar curve patterns. After change of workplace of the second author the patients could not be followed up as planned. Therefore a telephone interview was performed by the second author. RESULTS: 28 patients (average age 16.5 years) have been reached, 9 of them were still under treatment. No patient has been operated (Rate of surgery 0%) and only one was not satisfied with cosmetic outcome of treatment. DISCUSSION: Rate of surgery was far less than reported in recent studies using the same inclusion criteria even when all drop outs where rated as failures. CONCLUSION: Rate of surgery can be reduced with the help of Chêneau braces of the latest standard and satisfactory in-brace correction. Brace treatment with the Chêneau brace seems effective and therefore clearly is indicated. Clinical outcomes may be more important for the patient than radiologic outcomes.

Soft braces in the treatment of Adolescent Idiopathic Scoliosis (AIS) - Review of the literature and description of a new approach.

BACKGROUND: The use of soft braces to treat scoliosis has been described by Fischer as early as 1876. With the help of elastic straps, as the authors suggested, a corrective movement for individual curve patterns should be maintained in order to inhibit curve progression. Today this concept has been revived besides soft 3 point pressure systems. Some shortcomings have been revealed in literature in comparison with hard braces, however the concept of improving quality of life of a patient while under brace treatment should furtherly be considered as valuable. Purpose of this review is to gather the body of evidence existent for the use of soft braces and to present recent developments. METHOD: A review of literature as available on Pub Med was performed using the key words 'scoliosis' and 'soft brace' at first. The search was expanded using 'scoliosis' and the known trademarks (1) 'scoliosis' and 'SpineCor', (2) 'scoliosis' and 'TriaC', (3) 'scoliosis' and 'St. Etienne brace', (4) 'scoliosis' and 'Olympe'. The papers considered for inclusion were new technical descriptions, preliminary results, cohort studies and controlled studies. RESULTS: When searching for the terms 'scoliosis' and 'SpineCor': 20 papers have been found, most of them investigating a soft brace, for 'scoliosis' and 'TriaC': 7 papers displayed, for 'scoliosis' and 'St. Etienne brace': one paper displayed but not meeting the topic and for 'scoliosis' and 'Olympe': No paper displayed. Four papers found on the SpineCor™ were of prospective controlled or prospective randomized design. These papers partly presented contradictory results. Two papers were on soft Boston braces used in patients with neuromuscular scoliosis. DISCUSSION: There is a small but consistent body of evidence for the use of soft braces in the treatment of scoliosis. Contradictory results have been published for samples treated during the pubertal growth spurt. In a biomechanical analysis the reason for the lack of effectiveness during this period has been elaborated. Improved materials and the implementation of corrective movements respecting also the sagittal correction of the scoliotic spine will hopefully contribute to an improvement of the results achievable. CONCLUSIONS: The treatment of scoliosis using soft braces is supported by some papers providing a small body of evidence. During the growth spurt the use of soft braces is discussed contradictory. There is insufficient evidence to draw definite conclusions about effectiveness and safety of the intervention.

"Brace Technology" Thematic Series - The ScoliOlogiC® Chêneau light™ brace in the treatment of scoliosis.

BACKGROUND: Bracing concepts in use today for the treatment of scoliosis include symmetric and asymmetric hard braces usually made of polyethylene (PE) and soft braces. The plaster cast method worldwide seems to be the most practiced technique for the construction of hard braces at the moment. CAD (Computer Aided Design) systems are available which allow brace adjustments without plaster. Another possibility is the use of the ScoliOlogiC™ off the shelf system enabling the Certified Prosthetist and Orthotist (CPO) to construct a light brace for scoliosis correction from a variety of pattern specific shells to be connected to an anterior and a posterior upright. This Chêneau light™ brace, developed according to the Chêneau principles, promises a reduced impediment of quality of life in the brace. The correction effects of the first 81 patients (main diagnosis Adolescent Idiopathic Scoliosis (AIS) [n = 64] or Early Onset Scoliosis (EOS) [n = 15]), treated according to the principles of the Chêneau light™ brace have shown a satisfactory in-brace correction exceeding 50% of the initial Cobb angle. BRACE DESCRIPTION: The ScoliOlogiC® off the shelf bracing system enables the CPO to construct a light brace for scoliosis correction from a variety of pattern specific shells to be connected to an anterior and a posterior upright. This brace, when finally adjusted is called Chêneau light™ brace. The advantage of this new bracing system is that the brace is available immediately, is easily adjustable and that it can also be easily modified. This avoids construction periods of sometimes more than 6 weeks, where the curve may drastically increase during periods of fast growth. The disadvantage of this bracing system is that there is a wide variability of possibilities to arrange the different shells during adjustment. RESULTS: The Cobb angle in the whole group was reduced by an average of 16,4°, which corresponds to a correction effect of 51%. The differences were highly significant in the T-test (T = 17,4; p < 0,001). The best correction effects achieved with Chêneau braces reported in literature so far are about 40% in two different studies. The correction effect was highest in lumbar and thoracolumbar curve patterns (62%; n = 18). In thoracic scoliosis the correction effect was 36% (n = 41) and in double major curve patterns 50% (n = 22). The correction effect was affected in a slightly negative way due to age (r = -0,24; p = 0,014), negatively with the Risser stage (-0,29; p = 0,0096) and correlated negatively with the Cobb angle measured before treatment (r = -0,43; p < 0,0001). CONCLUSIONS: The use of the Chêneau light™ brace leads to correction effects above average when compared to correction effects of other braces described in literature. The reduction of material seems to increase patient's comfort and reduces the stress patients may suffer from whilst in the brace.80% of the adolescent population of scoliosis patients can be braced with the Chêneau light™ brace. In certain patterns of curvature and in the younger population with an age of less than 11 years, other approaches have to be used, such as plaster based bracing or the application of CAD/CAM based orthoses.

Treatment of chronic low back pain in patients with spinal deformities using a sagittal re-alignment brace.

BACKGROUND: For adult scoliosis patients with chronic low back pain bracing is initially indicated before spinal surgery is considered. Until recently there has been a lack of research into the effect upon pain reductions in the mid and long-term. Promising results have been documented in short-term studies for the application of a sagittal re-alignment brace in patients with spinal deformities and along with pain; however mid-term and long-term results are not yet available. The purpose of this study is to investigate the mid-term effects of this brace with respect to pain control. MATERIALS AND METHODS: 67 patients (58 females and 9 males) with chronic low back pain (> 24 months) and the diagnosis of scoliosis or hyperkyphosis were treated with a sagittal re-alignment brace (physio-logic brace) between January 2006 and July 2007. The indication for this kind of brace treatment was derived from a positive sagittal re-alignment test (SRT) and the exclusion of successful conservative treatment during the last 24 months. The aim of this type of conservative intervention was to avoid surgery for chronic low back pain. RESULTS: The average pain intensity was measured on the Roland and Morris VRS (5 steps) before treatment. This was 3.3 (t1), at the time of brace adjustment it was 2.7 (t2) and after at an average observation time of 18 months it was 2.0 (t3). The differences were highly significant in the Wilcoxon test. DISCUSSION: Short-term measurements showed that a significant pain reduction is possible in chronic postural low back pain using a sagittal re-alignment brace inducing lumbar re-lordosation. In a preliminary report at adjustment (t2), highly significant improvements of pain intensity have also been demonstrated. At 6 months of treatment however, no improvement was measured. The improvement of the mid-term effects (18 months) found in this study compared to the preliminary report may be due to the changed approach to compliance: whilst the bracing standard was not changed; the patients in this study were obligated to wear the brace for a minimum of 20 hrs per day for the first 6 months of treatment. CONCLUSION: The effect of the sagittal re-alignment brace leads to promising short-term improvements in patients with chronic low back pain and spinal deformities. Contrary to unspecific orthoses, which after a short period without persistent pain reduction are omitted by the patients, the sagittal re-alignment brace (physio-logic brace) leads to an effective reduction of pain intensity in mid-term even in patients who have stopped brace treatment after the initial 6 months of treatment. In conservative treatment of chronic low back pain specific approaches such as the sagittal re-alignment brace are indicated prior to considering the surgical options.

Unspecific chronic low back pain - a simple functional classification tested in a case series of patients with spinal deformities.

BACKGROUND: Up to now, chronic low back pain without radicular symptoms is not classified and attributed in international literature as being "unspecific". For specific bracing of this patient group we use simple physical tests to predict the brace type the patient is most likely to benefit from. Based on these physical tests we have developed a simple functional classification of "unspecific" low back pain in patients with spinal deformities. METHODS: Between January 2006 and July 2007 we have tested 130 patients (116 females and 14 males) with spinal deformities (average age 45 years, ranging from 14 years to 69) and chronic unspecific low back pain (pain for > 24 months) along with the indication for brace treatment for chronic unspecific low back pain. Some of the patients had symptoms of spinal claudication (n = 16). The "sagittal realignment test" (SRT) was applied, a lumbar hyperextension test, and the "sagittal delordosation test" (SDT). Additionally 3 female patients with spondylolisthesis were tested, including one female with symptoms of spinal claudication and 2 of these patients were 14 years of age and the other 43yrs old at the time of testing. RESULTS: 117 Patients reported significant pain release in the SRT and 13 in the SDT (> or = 2 steps in the Roland & Morris VRS). 3 Patients had no significant pain release in both of the tests (< 2 steps in the Roland & Morris VRS).Pain intensity was high (3,29) before performing the physical tests (VRS-scale 0-5) and low (1,37) while performing the physical test for the whole sample of patients. The differences where highly significant in the Wilcoxon test (z = -3,79; p < 0,0001).In the 16 patients who did not respond to the SRT in the manual investigation we found hypermobility at L5/S1 or a spondylolisthesis at level L5/S1. In the other patients who responded well to the SRT loss of lumbar lordosis was the main issue, a finding which, according to scientific literature, correlates well with low back pain. The 3 patients who did not respond to either test had a fair pain reduction in a generally delordosing brace with an isolated small foam pad inserted at the level of L 2/3, leading to a lordosation at this region. DISCUSSION: With the exception of 3 patients (2.3%) a clear distribution to one of the two classes has been possible. 117 patients were supplied successfully with a sagittal realignment test-brace (physio-logic brace) and 13 with a sagittal delordosing brace (spondylogic brace). There were patients with scoliosies and hyperkyphosiesbrace). Therefore a clear distribution of the patients from this sample to either chronic postural or chronic instability back pain was possible. In 2.3% a combined chronic low back pain from the findings obtained seems reasonable. CONCLUSION: Chronic unspecific low back pain is possible to clearly be classified physically. This functional classification is necessary to decide on which specific conservative approach (physical therapy, braces) should be used.Other factors than spinal deformities contribute to chronic low back pain.

Brace related stress in scoliosis patients - Comparison of different concepts of bracing.

BACKGROUND: The BSSQbrace questionnaire has been shown to be reliable with good internal consistency and reproducibility estimating the stress scoliosis patients have whilst wearing their brace. Eight questions are provided focussing on this topic. A max. score of 24 can be achieved (from 0 for most stress to 24 for no stress). The subdivision of the score values is: 0-8 (strong stress), 9-16 (medium stress) and 17-24 (little stress). STUDY DESIGN: Two BSSQbrace questionnaires have been posted to 65 patients under brace treatment from our Cheneau light data base. All patients had another kind of brace prior to the Cheneau light. The patients have been asked to rate their stress level using one questionnaire for the current brace and the other for the previous one. RESULTS: 63 Patients (59 girls and 4 boys) returned their fully completed questionnaires (average age 13,6 years, average Cobb angle 43,7 degrees). Stress level in the previous brace was 11,04 and in the Cheneau light(r) 13,87. The differences were highly significant in the t-test; t = -4,67; p < 0,001. CONCLUSION: The use of the Cheneau light(R) brace leads to reduced stress and/or impairment for the patients under treatment compared to heavier brace models used so far.