The point boils down to: why is anyone conducting a study of a specific bracing method when - they are not fully certified in the application of the method?

From the Manufacturer:


It has come to our attention that an article entitled “The effect of rigid versus flexible spinal orthosis on the clinical efficacy and acceptance of the patients with adolescent idiopathic scoliosis” was published in the May 2008 issue of Spine Journal.[1] The SpineCorporation is the company responsible for production, supply, and training in the use of the SpineCor treatment system and we have serious concerns about the methods and validity of this study. We would like to point out two serious issues in the way in which this study was conducted and we believe these factors invalidate the data of the SpineCor treatment group and therefore the comparative results of the study.

1) The authors in this study and the facility at which patients were treated with SpineCor are not qualified to a proficient standard in the SpineCor treatment system. They should not be providing this treatment therapeutically to patients, let alone conducting research into its efficacy. We believe this to be seriously unethical and detrimental to the patients involved.

2) This treatment centre has not been supplied with enough initial SpineCor components to effectively brace 22 patients. They also have not received enough replacement components necessary to effectively maintain this amount of SpineCor braces. In reference to point 1, the SpineCor brace is a unique treatment system for idiopathic scoliosis that is unlike any other type of spinal orthosis ever developed[2]. It does not share the same treatment principles of 3-point pressure that rigid orthoses use and its use requires specific and extensive training. Training and an expertise in rigid bracing does not transfer to SpineCor; specific training and qualification is necessary. To attain the necessary skills to be a safe and effective SpineCor provider, candidates are required to attend an initial Phase 1 theory course. On completion of Phase 1, providers are eligible to complete a Phase 2 practical training which involves treating patients in front of a qualified SpineCor trainer. Distributors of the SpineCor brace are under a contractual obligation only to supply SpineCor braces and components to Phase 2 certified providers. To remain certified, practitioners must see a minimum number of patients using this system each year or recertification is necessary[3]. These strict systems are in place to ensure quality of treatment and consistency of results.

None of the authors of this paper are certified in SpineCor treatment nor have they ever received significant training in the SpineCor system. Some of the technicians working with these authors at the scoliosis clinic in Hong Kong have received basic introductory training, but they are not certified SpineCor providers and are not considered to have received training to a sufficient standard to use the SpineCor system without supervision.