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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 (TRAR…

Overview of attention for article published in BMC Musculoskeletal Disorders, February 2015
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Title
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
Published in
BMC Musculoskeletal Disorders, February 2015
DOI 10.1186/s12891-015-0471-z
Pubmed ID
Authors

Luc Vanden Bossche, Guy Vanderstraeten

Abstract

BackgroundShoulder 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/DesignThis 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.DiscussionIt is hoped that the results of this trial will expand the treatment options and evidence base available for the management of rotator cuff disease.Trial registrationClinicalTrials.gov: NCT01702233. EudraCT number: 2012-003393-12.

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X Demographics

The data shown below were collected from the profiles of 3 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 220 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Spain 3 1%
Germany 1 <1%
Unknown 216 98%

Demographic breakdown

Readers by professional status Count As %
Student > Master 40 18%
Student > Bachelor 24 11%
Student > Doctoral Student 19 9%
Researcher 17 8%
Other 16 7%
Other 36 16%
Unknown 68 31%
Readers by discipline Count As %
Medicine and Dentistry 68 31%
Nursing and Health Professions 39 18%
Pharmacology, Toxicology and Pharmaceutical Science 6 3%
Biochemistry, Genetics and Molecular Biology 5 2%
Agricultural and Biological Sciences 4 2%
Other 23 10%
Unknown 75 34%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 19 October 2017.
All research outputs
#14,212,891
of 22,785,242 outputs
Outputs from BMC Musculoskeletal Disorders
#2,122
of 4,039 outputs
Outputs of similar age
#187,256
of 352,279 outputs
Outputs of similar age from BMC Musculoskeletal Disorders
#24
of 51 outputs
Altmetric has tracked 22,785,242 research outputs across all sources so far. This one is in the 35th percentile – i.e., 35% of other outputs scored the same or lower than it.
So far Altmetric has tracked 4,039 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 7.1. This one is in the 43rd percentile – i.e., 43% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 352,279 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 44th percentile – i.e., 44% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 51 others from the same source and published within six weeks on either side of this one. This one is in the 49th percentile – i.e., 49% of its contemporaries scored the same or lower than it.