A multi-center, double-blind, randomized, placebo-controlled trial protocol to assess Traumeel injection vs dexamethasone injection in rotator cuff syndrome : the TRAumeel in ROtator cuff syndrome (TRARO) study protocol

Background: Shoulder pain is a common musculoskeletal symptom with a wide range of potential causes; however, the majority of conditions can be managed with conservative treatment. The aim of this study is to assess the efficacy and safety of Traumeel injections versus corticosteroid injections and placebo in the treatment of rotator cuff syndrome and bursitis and expand the current evidence base for the conservative treatment of rotator cuff syndrome. Methods/Design: This is a multi-center, randomized, double-blind, 16-week, three-arm, parallel-group, active-and placebo-controlled trial to assess the efficacy and safety of Traumeel 2 ml injection versus dexamethasone 8 mg injection versus placebo (saline solution). Patients will be randomly allocated to Traumeel, dexamethasone or placebo in a 2: 2: 1 randomization. After 1 week screening, patients will receive 3 injections at weekly intervals (days 1, 8 and 15) with additional follow-up assessments on day 22, a telephone consultation in week 9 and a final visit at week 15. Male and female patients aged 40 to 65 years, inclusive, will be recruited if they have acute episodes of chronic rotator cuff syndrome and/or bursitis. Patients with calcifications in the shoulder joint or a complete rotator cuff tear will be excluded. At least 160 patients will be recruited. All subacromial injections will be performed under ultrasound guidance utilizing a common technique. The only rescue medication permitted will be paracetamol (acetaminophen), with usage recorded. The primary endpoint is change from baseline in abduction-rotation pain visual analog scale (0-100 mm scale, 0 corresponds to no pain and 100 to extreme pain) at day 22 (Traumeel injections versus dexamethasone injections) for active external rotation. Secondary efficacy parameters include range of motion, disability of arm, shoulder, hand score and patient's/investigator's global assessment. Clinical efficacy will be assessed as non-inferiority of Traumeel with respect to dexamethasone regarding the primary efficacy parameter. Discussion: It is hoped that the results of this trial will expand the treatment options and evidence base available for the management of rotator cuff disease

A randomized, single-blind cross-over design evaluating the effectiveness of an individually defined, targeted physical therapy approach in treatment of children with cerebral palsy

Objective: A pilot study to compare the effectiveness of an individual therapy program with the effects of a general physical therapy program. Design: A randomized, single-blind cross-over design. Participants: Ten ambulant children with bilateral spastic cerebral palsy, age four to nine years. Intervention: Participants were randomly assigned into a ten-week individually defined, targeted or a general program, followed by a cross-over. Main outcome measures: Evaluation was performed using the Gross Motor Function Measure-88 and three-dimensional gait analysis. General outcome parameters were Gross Motor Function Measure-88 scores, time and distance parameters, gait profile score and movement analysis profiles. Individual goal achievement was evaluated using z-scores for gait parameters and Goal Attainment Scale for gross motor function. Results: No significant changes were observed regarding gross motor function. Only after individualized therapy, step-and stride-length increased significantly (p = 0.022; p = 0.017). Change in step-length was higher after the individualized program (p = 0.045). Within-group effects were found for the pelvis in transversal plane after the individualized program (p = 0.047) and in coronal plane after the general program (p = 0.047). Between-program differences were found for changes in the knee in sagittal plane, in the advantage of the individual program (p = 0.047). A median difference in z-score of 0.279 and 0.419 was measured after the general and individualized program, respectively. Functional goal attainment was higher after the individual therapy program compared with the general program (48 to 43.5). Conclusion: The results indicate slightly favorable effects towards the individualized program. To detect clinically significant changes, future studies require a minimal sample size of 72 to 90 participants

Spectrum of topics for world congresses and other activities of the International Society for Physical and Rehabilitation Medicine (ISPRM) : a first proposal

Background: One of the objectives of the International Society for Physical and Rehabilitation Medicine is to improve the continuity of World Congresses. This requires the development of an abstract topic list for use in congress announcements and abstract submissions. Methods: An abstract topic list was developed on the basis of the definitions of human functioning and rehabilitation research, which define 5 main areas of research (biosciences in rehabilitation, biomedical rehabilitation sciences and engineering, clinical Physical and Rehabilitation Medicine (PRM) sciences, integrative rehabilitation sciences, and human functioning sciences). For the abstract topic list, these research areas were grouped according to the proposals of congress streams. In a second step, the first version of the list was systematically compared with the topics of the 2003 ISPRM World Congress. Results: The resulting comprehensive abstract topic list contains 5 chapters according to the definition of human functioning and rehabilitation research. Due to the high significance of clinical research, clinical PRM sciences were placed at the top of the list, comprising all relevant health conditions treated in PRM services. For congress announcements a short topic list was derived. Discussion: The ISPRM topic list is sustainable and covers a full range of topics. It may be useful for congresses and elsewhere in structuring research in PRM

The evidence-base for conceptual approaches and additional therapies targeting lower limb function in children with cerebral palsy : a systematic review using the International Classification of Functioning, Disability and Health as a framework

Objective: This systematic review provides an overview of the effectiveness of conceptual approaches and additional therapies used in lower limb physical therapy of children with cerebral palsy and supports the development of clinical guidelines. Data sources and study selection: A literature search in 5 electronic databases was performed, extracting literature published between 1995 and 2009. Studies were evaluated using the framework recommended by the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM), which classifies outcomes according to the International Classification of Functioning, Disability and Health (ICF). Data extraction: Three evaluators rated the strength of evidence of the effects according to the AACPDM levels of evidence classification, and the quality of the studies according to the AACPDM conduct score system. Data synthesis: A total of 37 studies used conceptual approaches (neurodevelopmental treatment (NDT), conductive education, Vojta therapy, sensory integration, functional training and goal-oriented therapy) and 21 studies focused on additional therapies (aquatic therapy and therapeutic horse-riding). Conclusion: Level II evidence was found for the effectiveness of therapeutic horse-riding on posture and for NDT and functional training on gross motor function. Goal-oriented therapy and functional training were effective on the attainment of functional goals and participation. With level IV evidence, NDT was effective on all levels of the ICF