In Heo1, Byung-Cheul Shin1, Jae-Heung Cho2, In-Hyuk Ha3, Eui-Hyoung Hwang1, Jun-Hwan Lee4, Koh-Woon Kim2, Me-Riong Kim5, So-Young Jung6, Ojin Kwon6, Nam-Kwen Kim7, Dong-Wuk Son8, Kyung-Min Shin9. 1. Spine & Joint Center, Department of Korean Rehabilitation Medicine, Pusan National University Korean Medicine Hospital, Yangsan, South Korea; Division of Clinical Medicine, School of Korean Medicine, Pusan National University, Yangsan, South Korea. 2. Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, South Korea. 3. Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, South Korea. 4. Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea; University of Science & Technology, Korean Medicine Life Science, Campus of Korea Institute of Oriental Medicine, Daejeon, South Korea. 5. Jaseng Hospital of Korean Medicine, Seoul, South Korea. 6. Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea. 7. Department of Ophthalmology & Otolaryngology and Dermatology, School of Korean Medicine, Pusan National University, Yangsan, South Korea. 8. Department of Neurosurgery, Yangsan Pusan National University Hospital, Yangsan, South Korea. 9. Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, South Korea. Electronic address: kyungmin7221@kiom.re.kr.
Abstract
BACKGROUND: The purpose of this study was to investigate the effectiveness and safety between electroacupuncture (EA) combined with usual care (UC) and UC alone for pain reduction and functional improvement in patients with non-acute low back pain (LBP) after back surgery. METHODS: In this multicentre, randomised, assessor-blinded active-controlled trial, 108 participants were equally randomised to either the EA with UC or the UC alone. Participants in the EA with UC group received EA treatment and UC treatment twice a week for 4 weeks; those allocated to the UC group received only UC. The primary outcome was the VAS pain intensity score. The secondary outcomes were functional improvement (Oswestry Disability Index [ODI]) and the quality of life (EuroQol-5-dimension questionnaire [EQ-5D]). The outcomes were measured at Week 5. RESULTS: Significant reductions were observed in the VAS (mean difference [MD] -8.15; P=0.0311) and ODI scores (MD -3.98; P=0.0460) between two groups after 4 weeks of treatment. No meaningful differences were found in the EQ-5D scores and incidence of adverse events (AEs) between the groups. The reported AEs did not have a causal relationship with EA treatment. CONCLUSIONS: The results showed that EA with UC treatment was more effective than UC alone and relatively safe in patients with non-acute LBP after back surgery. EA with UC treatment may be considered as an effective, integrated, conservative treatment for patients with non-acute LBP after back surgery. CLINICAL TRIAL REGISTRATION: KCT0001939.
RCT Entities:
BACKGROUND: The purpose of this study was to investigate the effectiveness and safety between electroacupuncture (EA) combined with usual care (UC) and UC alone for pain reduction and functional improvement in patients with non-acute low back pain (LBP) after back surgery. METHODS: In this multicentre, randomised, assessor-blinded active-controlled trial, 108 participants were equally randomised to either the EA with UC or the UC alone. Participants in the EA with UC group received EA treatment and UC treatment twice a week for 4 weeks; those allocated to the UC group received only UC. The primary outcome was the VAS pain intensity score. The secondary outcomes were functional improvement (Oswestry Disability Index [ODI]) and the quality of life (EuroQol-5-dimension questionnaire [EQ-5D]). The outcomes were measured at Week 5. RESULTS: Significant reductions were observed in the VAS (mean difference [MD] -8.15; P=0.0311) and ODI scores (MD -3.98; P=0.0460) between two groups after 4 weeks of treatment. No meaningful differences were found in the EQ-5D scores and incidence of adverse events (AEs) between the groups. The reported AEs did not have a causal relationship with EA treatment. CONCLUSIONS: The results showed that EA with UC treatment was more effective than UC alone and relatively safe in patients with non-acute LBP after back surgery. EA with UC treatment may be considered as an effective, integrated, conservative treatment for patients with non-acute LBP after back surgery. CLINICAL TRIAL REGISTRATION: KCT0001939.