A randomized, double blind, multicenter trial to evaluate clinical effectiveness of 4.4 MHz-radiofrequency compared with ultrasound for patients with subacute low back pain
Jung Hwan Lee, MD, PhD1, Yong-Taek Lee, MD, PhD2, Hee-Jin Park, MD, PhD3, Jong Geol Do, MD2, Mi Hwa Kim, MS4, Jung Soo Won, BSc1, Sang-Ho Lee, MD, PhD5, Eun Kyung Kim, MS4, Sang Jun Kim, MD, PhD4
1Department of Physical and Rehabilitation Medicine, Spine Health Wooridul Hospital, 2Department of Rehabilitation Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 3Department of Radiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 4Department of Physical and Rehabilitation Medicine, Stem Cell & Regenerative Medicine Institute, Samsung Medical Center, 5Department of Neurosurgery, Spine Health Wooridul Hospital
Selecting the appropriate treatment for discogenic low back pain (DLBP) that cannot be controlled by conservatives is often difficult.
Because surgical techniques are invasive and can be associated with severe complications, a variety of alternative minimally invasive percutaneous intradiscal procedures have been attempted.
Percutaneous endoscopic lumbar annuloplasty and nucleoplasty (PELAN) is a minimally invasive treatment for DLBP
To identify the clinical efficacy of PELAN in treating patients with DLBP
To investigate the prognostic clinical or radiological variables.
Materials & Methods
PELAN was conducted by endoscopic catheter with laser equipment that was introduced through the cannula. Laser ablation was performed under direct visualization.
Evaluation of clinical improvement and success
Numeric rating scale (NRS) for back pain : ≥ 50% reduction
Oswestry disability index(%) (ODI%) : ≥ 40% reduction
Modified MacNab criteria : Excellent or Good
At short term(3-4 weeks) and long term follow up (at least 12 months)
Results & Discussion
NRS and ODI(%) were significantly reduced at short and long term follow up after PELAN.
62(69.7%) and 68(76.4%) : successful NRS at short & long
59(66.3%) and 68(76.4%) : successful ODI(%) at short & long
61% and 65.2% : successful McNab at short & long
Flexion pain was related to good clinical outcomes :
Flexion pain suggested DLBP, select good candidate of PELAN
Modic change related to poor clinical outcomes :
It represented persistent inflammation of the end plate and metabolic changes of adjacent bone marrow that PELAN could not treat
PELAN provided favorable clinical outcomes in DLBP.
Flexion pain was good prognostic factor.
Modic changes was poor prognostic factor.