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
Radiofrequency(RF) diathermy has advantages to produce clinical improvements, avoiding more invasive treatment related to serious adverse effects in patients with low back pain (LBP). Thus, development of RF diathermy is useful to provide treatment option in these patients.
To investigate the clinical effectiveness and safety of newly developed 4.4 MHz RF diathermy in patients with subacute LBP in comparison with those of ultrasound(US).
Materials & Methods
9 to 70 years old
subacute stage of LBP (1-6 months)
Randomization & Treatment
118 patients randomly allocated into RF(N=62) vs US group(N=56).
The RF group : 4.4 MHz RF diathermy(HIPER-500®)
The US group : Ultrasonic SUS-2N®
3 times per week for 4 weeks
Oswestry Disability Index(ODI)(%), Numeric rating scale(NRS)
Biering-Sorensen test, Up and go test,
North American Spine Society (NASS) 4 points satisfaction index
Results & Discussion
The RF and the US group accomplished significant reduction of ODI(%) and NRS, improvement of Biering-Sorensen test, up and go test at the end of and at 8 weeks after end of treatment.
The RF group showed significantly higher proportion of successful reduction of NRS than the US group
The TF group showed less requirement of analgesics at 8 weeks after treatment than the US group,
Newly developed 4.4 MHz RF diathermy obtained significantly better pain reduction at 8 weeks after treatment and comparable result to US in regard to pain reduction at the end of treatment and other clinical evaluations at the end of and at 8 weeks after treatment.