Trial reportEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2010
A randomised controlled trial on the effectiveness of bracing patients with idiopathic scoliosis: failure to include patients and lessons to be learnt.
Trial report in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Braces for idiopathic scoliosis in adolescents.The Cochrane database of systematic reviews · 2015Pooled it
- Nighttime Bracing or Exercise in Moderate-Grade Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial.JAMA network open · 2024Trial
- CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis: a randomised controlled trial protocol.BMC musculoskeletal disorders · 2013Trial
- Adherence and Radiological Outcomes in Braced Adolescents with Idiopathic Scoliosis: A Real-World Study Using Thermal Sensors.Journal of clinical medicine · 2025Article
- Effects of Structured Physical Therapy on Spinal Alignment in Idiopathic Scoliosis: A 12-Month Prospective Study.Diagnostics (Basel, Switzerland) · 2025Article
- Bracing Interventions Can Help Adolescents with Idiopathic Scoliosis with Surgical Indication: A Systematic Review.Children (Basel, Switzerland) · 2022Review
- The Measurement of Health-Related Quality of Life of Girls with Mild to Moderate Idiopathic Scoliosis-Comparison of ISYQOL versus SRS-22 Questionnaire.Journal of clinical medicine · 2021Article
- Reliability and validity of simplified Chinese version of the Italian spine youth quality of life questionnaire in adolescents with idiopathic scoliosis.BMC musculoskeletal disorders · 2021Article
- Polish Adaptation of the Italian Spine Youth Quality of Life Questionnaire.Journal of clinical medicine · 2021Article
- Article
- The effectiveness of combined bracing and exercise in adolescent idiopathic scoliosis based on SRS and SOSORT criteria: a prospective study.BMC musculoskeletal disorders · 2014Article
- Does brace treatment impact upon the flexibility and the correctability of idiopathic scoliosis in adolescents?European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2013Article
- Polish validation of Brace Questionnaire.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Trials often do not succeed in including as many patients as anticipated beforehand. The aim of this paper was to describe why we were not able to include more than a few patients in our randomized controlled treatment trial on the effectiveness of bracing patients with idiopathic scoliosis, and to describe which lessons can be learnt. A pilot study on the willingness to participate in such a trial was conducted amongst 21 patients and their parents. A description of how we prepared and designed this trial, the problems we faced and how we tried to improve the inclusion are given. A total of four patients were included, and 14 refused to participate in an 18-month period. There were a lot less eligible patients than anticipated (40 instead of 100 per year), and the patients' participation rate was much lower than we had found in our pilot study (21% instead of 70%). The trial failed to include more than a few patients because of an overestimation of the number of eligible patients and because a lot less eligible patients were willing to participate compared to our pilot study. One reason for a low participation rate could be that this trial evaluated a frequently used existing treatment instead of a new treatment, and patients and parents might be afraid of not being treated (despite an intensive secure system for the control arm).
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Registered trials
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