We thank Professor Greitemann and Professor Minne for their letters to the editor, which lend further support to our own request for further clinical studies on orthotic treatments for the spinal disorders we discussed in our article.
The study by Kuijper et al. was the only randomized controlled trial (RCT) that showed a similar effect when using semirigid orthoses in patients with acute cervicobrachialgia after three and six weeks’ treatment as when using a physiotherapeutic approach. No efficacy has thus far been shown for soft orthoses or for chronic cervical facet syndromes.
For reasons of restricted space we did not discuss fractures in our article. Prof. Minne rightly points out that two RCTs have been published of the treatment of acute osteoporotic vertebral fracture that showed a positive effect for the Spinomed R orthosis. Longo and colleagues mentioned one of these studies in their 2012 systematic review (1) as the only RCT on this subject. For this reason, these studies are a great example for good quality clinical studies of orthoses.
Clinical studies are indispensable for the purpose of assessing medical treatment approaches. Medicine’s recent history has numerous examples of empirically based treatment measures that were found to have been useless or even harmful (2). Clinical and biomechanical studies of orthotic treatment of the spine have been published multifariously but have often been methodologically inadequate for the purposes of confirming the efficacy of orthotic treatment, and for this reason these have not been included in meta-analyses and systematic reviews. This situation is unlikely to improve, as a glance at the large study registries (Deutsches Register klinischer Studien [German Clinical Trials Register, DRKS], ClinicalTrials.gov) confirms, because no studies assessing the efficacy of spinal orthoses—except in scoliosis and fractures—are currently registered. In view of the volume of prescriptions in Germany alone, it should be exceptionally easy to conduct high-quality studies to get closer to answers to open questions. The problems of heterogeneity of diagnoses and patient groups, as mentioned by Professor Greitemann, could be adjusted for in an adequate study design. The motivation for high-quality studies in the industry is low, for understandable reasons: license approval exists and the volume of prescriptions is high. It is therefore our responsibility as physicians to critically question orthotic treatment of the spine. Unfortunately, for clinical research of orthotic treatment of the spine, Altman’s 1994 quote still applies: “We need less research, better research, and research done for the right reasons” (3).
Dr. med. Kourosh Zarghooni
Klinik und Poliklinik für Orthopädie und Unfallchirurgie
Conflict of interest statement
Dr. Zarghooni has received payment for a research project initiated by himself from Bauerfeind.
|1.||Longo UG, Loppini M, Denaro L, Maffulli N, Denaro V: Conservative management of patients with an osteoporotic vertebral fracture: |
A review of the literature. J Bone Joint Surg Br 2012; 94: 152–7. CrossRef MEDLINE
|2.||Editorial commentary. Why fair tests are needed. 2007. Available at: www.jameslindlibrary.org.|
|3.||Altman DG: The scandal of poor medical research. BMJ 1994; 308: 283–4. CrossRef MEDLINE|
|4.||Zarghooni K, Beyer F, Siewe J, Eysel P: The orthotic treatment of acute and chronic disease of the cervical and lumbar spine. Dtsch Arztebl Int 2013; 110(44): 737–42. VOLLTEXT|