The aim of the study is 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 objectives of the study are 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, to be conducted through UCLan movement analysis laboratory is to be by randomised control pilot study. All patients will receive an advice and information booklet which will include 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 will comprise usual care consisting of advice and exercises, with the second group receiving usual care plus LumbaCurve.
Primary outcome measure will be 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.
Back pain is a major international health problem, with a lifetime prevalence of 80–85% that poses substantial challenges for clinical management. In the UK, each year 6–9% of adults consult their GP with back pain, with only 20–40% no longer reporting pain or disability 12 months later.
LumbaCurve, which showcased at the Back Pain Show at Olympia, London last month, is a patented device designed in the UK and Netherlands to help bring relief to sufferers of lower back pain. How does LumbaCurve work? LumbaCurve initially provides a passive gravity assisted traction (PGAT) to stretch the lower back, causing the vertebral joints to separate. This in turn, relaxes the discs and frees up the spinal nerves, thus giving pain relief, as practised by physiotherapists, Chiropractors, and Osteopaths.
Confidence in the commercial potential LumbaCurve has been reflected in the recent substantial investment in the company by bio medical venture capital organisation Spark Impact.
LumbaCurve International director David Pegg explained “Trials with users and customer feedback is very positive in terms of the effectiveness of the device to help reduce stiffness, increase mobility, and improve posture. However these endorsement and lumbaCurve testimonials are subjective rather than objective and scientific, hence the need for this research into the effectiveness of LumbaCurve as a natural cure for back pain, through scientific evaluation and validation.
We are optimistic that a successful outcome of the trial will lead to the potential publication of a scientific paper on the effectiveness of LumbaCurve back pain therapy. This in turn will accelerate the commercialisation process and help us to secure the interest and take up by healthcare establishments and professionals, both in the UK and overseas”
To view videos of how LumbaCurve can help with back pain relief go to www.lumbacurve.co.uk