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

Influence of motor imagery training on gait rehabilitation in sub-acute stroke: a randomized controlled trial

Objective: To evaluate the effect of mental practice on motor imagery ability and assess the influence of motor imagery on gait rehabilitation in sub-acute stroke. Design: Randomized controlled trial. Subjects: A total of 44 patients with gait dysfunction after first-ever stroke were randomly allocated to a motor imagery training group and a muscle relaxation group. Methods: The motor imagery group received 6 weeks of daily mental practice. The relaxation group received a muscle relaxation programme of equal duration. Motor imagery ability and lower limb function were assessed at baseline and after 6 weeks of treatment. Motor imagery ability was tested using a questionnaire and mental chronometry test. Gait outcome was evaluated using a 10-m walk test (near transfer) and the Fugl-Meyer assessment (far transfer). Results: Significant between-group differences were found, with the vividness of kinesthetic imagery and the walking test results improving more in the motor imagery group than in the muscle relaxation group. There was no group interaction effect for the far transfer outcome score. Conclusion: Motor imagery training may have a beneficial task-specific effect on gait function in sub-acute stroke; however, longer term confirmation is required

Motor imagery ability in patients with traumatic brain injury

Oostra KM, Vereecke A, Jones K, Vanderstraeten G, Vingerhoets G. Motor imagery ability in patients with traumatic brain injury. Arch Phys Med Rehabil 2012;93:828-33. Objective: To assess motor imagery (MI) ability in patients with moderate to severe traumatic brain injury (TBI). Design: Prospective, cohort study. Setting: University hospital rehabilitation unit. Participants: Patients with traumatic brain injury (mean coma duration, 18d) undergoing rehabilitation (n=20) and healthy controls (n=17) matched for age and education level. Interventions: Not applicable. Main Outcome Measures: The vividness of MI was assessed using a revised version of the Movement Imagery Questionnaire-Revised second version (MIQ-RS); the temporal features were assessed using the time-dependent motor imagery (TDMI) screening test, the temporal congruence test, and a walking trajectory imagery test; and the accuracy of MI was assessed using a mental rotation test. Results: The MIQ-RS revealed a decrease of MI vividness in the TBI group. An increasing number of stepping movements was observed with increasing time periods in both groups during the TDMI screening test. The TBI group performed a significantly smaller number of imagery movements in the same movement time. The temporal congruence test revealed a significant correlation between imagery and actual stepping time in both groups. The walking trajectory test revealed an increase of the imagery and actual walking time with increasing path length in both groups, but the ratio of imaginary walking over actual walking time was significantly greater than 1 in the TBI group. Results of the hand mental rotation test indicated significant effects of rotation angles on imagery movement times in both groups, but rotation time was significantly slower in the TBI group. Conclusions: Our patients with TBI demonstrated a relatively preserved MI ability indicating that MI could be used to aid rehabilitation and subsequent functional recovery

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

The effect of experimental low back pain on lumbar muscle activity in people with a history of clinical low back pain: a muscle functional MRI study

In people with a history of low back pain (LBP), structural and functional alterations have been observed at several peripheral and central levels of the sensorimotor pathway. These existing alterations might interact with the way the sensorimotor system responds to pain. We examined this assumption by evaluating the lumbar motor responses to experimental nociceptive input of 15 participants during remission of unilateral recurrent LBP. Quantitative T2 images (muscle functional MRI) were taken bilaterally of multifidus, erector spinae, and psoas at several segmental levels (L3 upper and L4 upper and lower endplate) and during several conditions: 1) at rest, 2) upon trunk-extension exercise without pain, and 3) upon trunk-extension exercise with experimental induced pain at the clinical pain-side (1.5-ml intramuscular hypertonic saline injections in erector spinae). Following experimental pain induction, muscle activity levels similarly reduced for all three muscles, on both painful and nonpainful sides, and at multiple segmental levels (P = 0.038). Pain intensity and localization from experimental LBP were similar as during recalled clinical LBP episodes. In conclusion, unilateral and unisegmental experimental LBP exerts a generalized and widespread decrease in lumbar muscle activity during remission of recurrent LBP. This muscle response is consistent with previous observed patterns in healthy people subjected to the same experimental pain paradigm. It is striking that similar inhibitory patterns in response to pain could be observed, despite the presence of preexisting alterations in the lumbar musculature during remission of recurrent LBP. These results suggest that motor output can modify along the course of recurrent LBP