Clinical trial NCT03118271: Comparison of the Effect of Lumbar Traction, Spinal Manipulation, and Surgery in the Treatment of Lumbar Disc Herniation
Official title: Comparison of the Effect of Lumbar Traction, Spinal Manipulation, and Surgery in the Treatment of Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar Disc Herniation
Lumbar Traction
Spinal Manipulation
Lumbar Surgery
Keywords: lumbar disc herniation
lumbar traction
spinal manipulation
lumbar surgery
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of lumbar traction, lumbar spinal manipulation and lumbar surgery in the treatment of LDH.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age\>20 and less than 80 y/o with LDH with moderate to severe (VAS pain \> 4) LBP and/or sciatica. LDH should be proved by MRI of the lumbosacral spine. The duration of pain is less than 1 month.

Exclusion Criteria:

1. LBP probable due to serious spinal pathology such as spinal tumor, infection, and inflammatory disease such as ankylosing spondylitis.28
2. LDH with progressive weakness in the lower extremities or symptoms and signs suggesting cauda equina lesion.
3. Concomitant serious medical conditions.
4. History of spinal surgery before.
5. Severe osteoporosis or image studies suggesting instability of the lumbosacral spine.

Primary outcomes:
measure: VAS pain score
timeFrame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.
Secondary outcomes:
measure: Global impression of change
timeFrame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.
measure: Modified Oswestry Disability Questionnaire (MODQ)
timeFrame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.
measure: SF-36
timeFrame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: ShinKongHospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Lin-Fen Hsieh, M.D
role: PRINCIPAL_INVESTIGATOR
References: