Description The Jia-ji points (six acupuncture points; bilateral EX-B2 at L3, L4, and L5) and a maximum of nine additional acupuncture points were used.
Experimental Description
108 participants were equally rand- omised 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.
Sample Count
108
Age
19-70
Control
Std
UC alone(n=54)
Experiment
EA with UC(n=54)
Indicator
Visual analog scale(VAS)Oswestry disability index(ODI)EuroQol-5-dimension questionnaire(EQ-5D)Incidence of adverse events
Stimulation Method
EA
Induction Method
Electroacupuncture Instrument Model
Manufacturer
Frequency
Waveform
Strength
Induction Time
ES-160
ITO Co. Ltd, Tokyo, Japan
50 Hz
-
-
15 min
Acupuncture_Needle
Needle_Manufacturer
Needle_Depth
0.25×40 mm
Dong Bang Acupuncture, Inc., Seongnam, South Korea
-
Description The participants in the EA with UC group received a total of eight sessions (twice per week) of EA treatment in addition to UC treatment for 4 weeks. The EA treatment was performed using disposable stainless-steel needles (0.25 × 40 mm; Dong Bang Acupuncture, Inc., Seongnam, South Korea). The Jia-ji points (six acupuncture points; bilateral EX-B2 at L3, L4, and L5) and a maximum of nine additional acupuncture points were used. These additional acupuncture points were chosen according to the patient’s symptoms. Electrical stimulation was applied to four Jia-ji acupuncture points (bilateral EX-B2 at L3 and L5) for 15 min at 50 Hz using an electrical stimulator (ES-160; ITO Co. Ltd, Tokyo, Japan). The participants in the EA with UC group also received UC treatment for the 4 week treatment period (see the following for details).
No meaningful differences were found in incidence of adverse events (AEs) between the groups. The reported AEs did not have a causal relationship with EA treatment.
Contraindications
Those for whom acupuncture was potentially inappropriate or unsafe
Effector
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. 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.
Multicentre randomised controlled clinical trial of electroacupuncture with usual care for patients with non-acute pain after back surgery.
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."
