LumbaCurve International has announced the successful completion of the clinical evaluation of it’s innovative back pain relief product and needless to say, the results were as expected in that LumbaCurve was found to be significantly more effective than the standard NHS care guidelines against which it was being compared.
The independent evaluation, carried out by the Allied Health Research Unit University of Central Lancashire (UCLan) was designed to determine the clinical effectiveness of LumbaCurve back pain relief product in the management of simple mechanical back pain, and to identify if the addition of LumbaCurve to usual care improve patient outcome.
The study objectives were to:-
- Determine the pre and post function treatment function when using LumbaCurve.
- Determine the pre and post treatment pain when using LumbaCurve.
- Determine if there is any significant patient benefit in function and pain when using LumbaCurve compared to a control group of usual care
The study, conducted through UCLan’s movement analysis laboratory was by randomised control pilot study. All patients received an advice and information booklet which contained simple self help messages such as the use of analgesic and home heat or cold therapy for back pain relief along with guidance on the benefits of general exercise such as walking .
Group one received ‘usual care’ consisting of advice and exercises, with the second group receiving usual care plus LumbaCurve. Primary outcome measure was by Roland and Morris Disability questionnaire, with secondary outcomes being measured using Oswestry Disability Index and Numeric Pain Rating Scale (NPRS) for intensity of lumbar pain and stiffness.
An abstract of the clinical trial results was presented at the Society for Back Pain Research annual conference in Dublin, Ireland outlining the effectiveness of LumbaCurve in treating simple mechanical back pain. The findings concluded that through a four week intervention programme, significant improvements in patient reported back pain levels are demonstrated following standardised care plus LumbaCurve intervention. The research abstract is to be published in the Bone and Joint Journal and a Journal paper submission to the European Spine Journal is pending
LumbaCurve director David Pegg commented, “We were pleased with the feedback we have received from users and indeed healthcare professionals such as the club doctor at a Premier League football club, but we wanted to substantiate this scientifically to differentiate LumbaCurve from the many products in the market for back pain relief that are simply unproven. In order to do this, we submitted LumbaCurve for clinical evaluation in the form of randomised control group trials comparing it directly with standard NHS treatment guidelines for low back pain.. A major international distributor has now taken on LumbaCurve so confidence in this drug free product is growing”
Consultant orthopaedic surgeon, Mr George Ampat FRCS, commented, “Having personally used the LumbaCurve device after suffering from lower back pain, I believe that LumbaCurve is of benefit to some patients suffering from discal problems, amongst other lower back pain issues that commonly occur. I am very interested in the ongoing development of this product.”
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