The efficacy of the IDD-protocol with Accu-Spina for patients with low back pain

Low back pain poses a significant problem to society. An annual growth rate of
20% in costs is expected for the next five years in the US. Although initial
conservative therapy may be beneficial, persisting chronic low back pain (LBP)
may frequently lead to surgical intervention. Any non- invasive or minimal
invasive treatment as an alternative to surgery deserves attention for the
possible benefit to the LBP patient. The Accu-Spina System is an FDA cleared,
class II medical device that delivers a non - invasive dynamic therapy focused
on the treatment of the intervertebral disc when it is considered the main
source of LBP. The mechanism of the device is unloading of the intervertebral
disc and facet joint due to temporary repeated distraction, positioning and
relaxation cycles. In a treatment program in which is opted for sequential
treatment, this program may relieve LBP and create an environment for disc
regeneration. The hypothesis behind the hypothesized working mechanism may be
that a negative intradiscal pressure during distraction may increase nutrient
flow into the disc.

The primary objective of the study is to investigate whether the IDD
(Intervertebral Differential Dynamics) protocol with Accu-Spina on the VAS low
back pain score at 3 months posttreatment.

The study is a double blind, single center, randomised controlled trial of a
non-invasive treatment in the early stage of introduction in the European
Union. For the study, 60 consecutive patients will be included. These patients
will be evaluated pretreatment and posttreatment at 2 and 6 weeks and at 3
months.

The intervention under investigation is the Accu-Spina treatment. The
therapeutic effect of the Accu-Spina treatment is accomplished through
distraction to the affected motion segment. The distraction yields a negative
pressure in the intervertebral disc facilitating influx of fluids, oxygen and
nutrients. The Accu-Spina protocol consists of 20 treatments of half an hour
over 6 weeks.

The intervention will be applied by one physiotherapist. The intervention will
be accompanied by conservative graded activity for as well the experimental as
control group. The graded activity program will start 2 weeks before initiation
of treatment with the Accu-Spina protocol and will end at the same time. The
graded activity program consists 4 days per week with each of 2 hours of
training.

Burden for the patient is the time investment and treatment sessions at the
Accu-Spina apparatus. The distraction sessions are not painfull and hardly to
distinguish between the massage parts of the session, which are considered
pleasant treatment.