Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; Design of a prospective randomized controlled trial
2009-08-05
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Background. The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD). This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness of PLDD versus standard surgical procedure has been performed. We present the design of a randomized controlled trial, studying the cost-effectiveness of PLDD versus conventional open discectomy in patients with sciatica from lumbar disc herniation. Methods/design. The study is a randomized prospective multi-center trial, in which two treatment strategies are compared in a parallel group design. Patients (age 18-70 years) visiting the neurosurgery department of the participating hospitals, are considered for inclusion in the trial when sciatica due to lumbar disc herniation has lasted more than 8 weeks. Patients with disc herniation smaller than 1/3 of the spinal canal diameter, without concomitant lateral recess stenosis or sequestration, are eligible for participation, and are randomized into one of two treatment arms; either Percutaneous Laser Disc Decompression or conventional discectomy. The functional outcome of the patient, as assessed by the Roland Disability Questionnaire for Sciatica at 8 weeks and 1 year after treatment, is the primary outcome measure. The secondary outcome parameters are recovery as perceived by the patient, leg and back pain, incidence of re-intervention, complications, quality of life, medical consumption, absence of work and secondary costs. Discussion. Open discectomy is still considered to be the golden standard in the surgical treatment of lumbar disc herniation. Whether Percutaneous Laser Disc Decompression has at least as much efficacy as the standard surgical procedure, and is more cost-effective, will be determined by this trial. Trial registration. Current Controlled Trials ISRCTN25884790.
- adult
- article
- female
- human
- male
- methodology
- middle aged
- aged
- controlled study
- clinical trial
- controlled clinical trial
- randomized controlled trial
- adolescent
- intermethod comparison
- economics
- multicenter study
- outcome assessment
- prospective study
- decompression surgery
- treatment outcome
- hernia
- quality of life
- pathophysiology
- questionnaire
- hospital department
- urinary tract infection
- reoperation
- pathology
- health care cost
- health care utilization
- functional assessment
- intervertebral disk hernia
- intervertebral diskectomy
- leg pain
- ischialgia
- backache
- case report
- pain assessment
- hematoma
- absenteeism
- cost benefit analysis
- deep vein thrombosis
- disease duration
- cost effectiveness analysis
- instrumentation
- intervertebral disk
- low level laser therapy
- lumbar disk
- neurological complication
- percutaneous laser disc decompression
- lumbar vertebra
- postoperative infection
- postoperative thrombosis
- surgical patient
- therapy effect
- vertebral canal
- surgical ward
- patient
- treatment
- disc herniation
- outcome
- trial
- sciatica
- study
- herniation
- analysis
- research nurse
- research
- measure
- surgery
- spine
- scale
- percutaneou
- page number
- nurse
- laser
- difference
