Lumbar Disc Herniation Clinical Trial
Official title:
Comparison of the Effect of Lumbar Traction, Spinal Manipulation, and Surgery in the Treatment of Lumbar Disc Herniation
To compare the effect of lumbar traction, lumbar spinal manipulation and lumbar surgery in the treatment of LDH.
Back pain is the second leading cause of work absenteeism (after upper respiratory tract
complaints) and results in more lost productivity than any other medical condition. The
lifetime prevalence of back pain exceeds 70% in most industrialized countries,and the 1-year
prevalence for an episode of acute low back pain (LBP) has been estimated to be 65%. Sciatica
is present in about 25% of those with LBP, and one of the major cause of sciatica is
herniation of intervertebral disc (HIVD) of the lumbosacral spine or lumbar disc herniation
(LDH). In the United Kindom, the estimated prevalence of LDH is from 1% to 3%. Although 95%
of LBP patients recovered in 12 weeks, recurrent pain and disability were common and occurred
in 12% over the 18-month observation period.
Disc herniation may be purely annular, purely nuclear, or consist of a combination of annular
and nuclear tissues. Nuclear disc herniation track posteriorly between the anterior surface
of the posterior longitudinal ligament and the posterior surfaces of the annulus and
vertebral body and then into the spinal canal. Disc herniation may be described as protrusion
or extrusion (or sequestration, if the displaced disc material has lost completely any
continuity with the parent disc); contained or uncontained.
The usual presenting complaint is acute or chronic intermittent LBP with or without sciatica,
which is radiating pain in a dermatomal distribution and classically described as a burning,
stabbing, or electric sensation, sometimes accompanied with paresthesia. Central disc
herniations or herniation that have migrated can each result in a mixed clinical picture or,
alternately, signs of stenosis may predominate. The mechanism of pain is mutifactorial,
involving mechanical stimulation of the nerve endings in the outer annulus, direct
compression on the posterior longitudinal ligament, dura, or nerve root, and/or the chemical
inflammatory cascade induced by the exposed nucleus pulposus or annulus fibrosis.The classic
straight leg raising (SLR) test or Lasegue test is thought to be a useful clinical test to
demonstrate an inflammatory compressive process across single or multiple spinal nerve roots.
Magnetic resonance imaging (MRI) has become the examination of choice for diagnosing LDHs.It
has the advantage of having no known side effects or morbidity, no radiation exposure, and is
noninvasive. The sensitivity and specificity of MRI in detecting annular tears, disc
herniation, and nerve root swelling has been confirmed in several studies. MRI findings have
been correlated to clinical findings and are strong predictors of surgical outcomes. However,
morphological abnormalities demonstrated by MRI do not always reflect LBP or sciatica. MRI
should be interpreted with consideration of full clinical signs, symptoms, and other relevant
background.
Treatment of LDH consists of operative and non-operative treatments. Non-operative care of
LDH includes a wide range of different methods: lumbar supports, bed rest, oral analgesics
and muscle relaxants, lumbar traction, therapeutic exercise, spinal manipulation, epidural
steroid injections, and behavioral therapy.
Lumbar traction is a very popular therapy for treatment of LDH in our country. Patients would
be placed in traction with the expectation that stretching of the lumbar area would result in
distraction and elongation of the structural elements and resolution of pain. Other
physiological effects of lumbar traction including decrease in the intra-disc pressure,
relief of muscle spasm , reduction of prolapsed disc and forcing patients to bed rest.
Despite favorable outcomes have been reported previously,there are few scientifically
rigorous studies in the literature that allow the effect of traction to be distinguished from
the natural history of the pathology being treated.
Spinal manipulation for treatment of LBP or LDH has been practiced for hundreds of years.
Theories for the effect of manipulation include restoring normal motion to restricted
segments and impacts proprioceptive primary afferent neurons from paraspinal tissues. It also
affects pain processing by altering the central facilitated state of the spinal cord.
Multiple randomized controlled trials and systematic review have been done to assess the
efficacy of manual therapy. In a meta-analysis by Assendelft et al, spinal manipulation was
found to be more effective than placebo for acute and chronic LBP.Santilli et al also found
that active manipulation had more effect than simulated manipulation on pain relief of acute
back pain and sciatica with disc protrusion. However, in a recent review article, the authors
concluded that definitive values on safety and effectiveness of spinal manipulation cannot be
made, but they admit that many patients with LDH did undergo manipulative treatment, and
spinal manipulation may be effective in the treatment of symptomatic LDH.
The goal of surgery for a LDH is to remove the portion of disc that is impinging on the nerve
root. There are many options for surgery for LDH, including open discectomy, laminotomy,
laminectomy, or the combinations. There are also new techniques such as endoscopic
discectomy, laser discectomy, and electrothermal disc decompression. Choice of surgery
depends on surgeons' experience and condition of the patients. Favorable short-term results
have been reported before.
Although lumbar traction, spinal manipulation, and surgery have been used extensively in the
management of LDH, comparison of the three treatments has never been studied before. The
purpose of this study is to compare the effect of lumbar traction, spinal manipulation, and
surgery in the treatment of LDH.
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