Even though the prospective outcome and morbidity studies of Endoscopic Lumbar Decompression and Foraminoplasty have proved very encouraging, it has not been subjected to a randomised controlled clinical trial to fully establish the evidence base for the procedure. Whilst National Institute for Clinical Excellence and Health guidelines confirm that most patients are improved by the use of the technique, this organisation requires this base before the technique can be widely disseminated through the NHS.
Consequently a “shammed” study has been drawn up to evaluate a comparative series to establish that the technique actually is effective. The study will focus upon the reduction of back pain, referred pain, complications and cost when compared to placebo as placebo is suchg a powerful force. Patients will be randomised to either treatment.
This study is being designed and monitored with the help of the York Clinical Trials Unit and is is entitled “A randomised trial of Endoscopic Lumbar Decompression and Foraminoplasty versus Placebo in the treatment of Failed Back Surgery”.
Funding for this study is currently being sought from granting bodies.
