Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03118271
Study type Interventional
Source Shin Kong Wu Ho-Su Memorial Hospital
Contact
Status Terminated
Phase N/A
Start date January 2017
Completion date December 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05277818 - Post-marketing Clinical Follow-up of the Medical Device DIVA®
Recruiting NCT05467072 - PMCFU of an Annular Closure System
Withdrawn NCT03252691 - Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients
Withdrawn NCT01622413 - Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy N/A
Completed NCT04329598 - Effects of Whole-Body Electromyostimulation Application in Individuals With Lumbar Disc Hernia N/A
Completed NCT04061759 - Physiotherapy in Lumbar Disc Pathologies N/A
Completed NCT04073095 - Erector Spinae Plane Block and Modified-Thoracolumbar Interfascial Plane Block Following Lumbar Spinal Surgery N/A
Active, not recruiting NCT06140862 - Ankle Spine Syndrome "RAFFET Syndrome II N/A
Active, not recruiting NCT05613179 - Brain Effect Mechanism of Lever Positioning Manipulation on LDH Analgesia Based on Multimodal MRI N/A
Completed NCT04587401 - The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure N/A
Recruiting NCT05663437 - Effectiveness of Core Stabilization Exercises With and Without Neural Mobilization Technique in Female Patients With Lumbar Radiculopathy Due to Disc Herniation - an RCT Study N/A
Recruiting NCT06076408 - Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients N/A
Completed NCT05999253 - Comparison of the Efficacy of Thoracolumbar Interfascial Plane Block and Erector Spina Plane Block in Lumbar Discectomy
Recruiting NCT03002207 - Repairing the Defect of Intervertebral Disc With Autologous BMSC and Gelatin Sponge After Microendoscopic Discectomy for Lumbar Disc Herniation N/A
Not yet recruiting NCT05487690 - Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries N/A
Completed NCT05003726 - Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation N/A
Completed NCT05556538 - The Effect of Subcutaneous Fat Tissue Thickness on Lumbar Transforaminal Epidural Steroid Injection Treatment Success
Not yet recruiting NCT04083703 - Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse N/A
Completed NCT03832036 - The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients With Lumbar Disc Herniation N/A
Not yet recruiting NCT05584774 - Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty N/A