Patients were randomised to an EA plus usual care (UC) group or to a UC alone group at a 1:1 ratio.
Sample Count
39
Age
19-70
Control
Std
UC alone group(n=21)
Experiment
EA plus usual care (UC)group(n=18)
Indicator
Visual analog scale(VAS)Oswestry disability index(ODI)EuroQol-5-dimension questionnaire(EQ-5D)
Auxiliary Medication
UC included drug therapy, physiotherapy and an educational programme on management of LBP, and excluded such Korean medicine treatments as acupuncture, moxibustion and cupping.
Stimulation Method
EA
Induction Method
Electroacupuncture Instrument Model
Manufacturer
Frequency
Waveform
Strength
Induction Time
ES-160
ITO Co. Ltd, Tokyo, Japan
50 Hz
biphasic waveform
-
15 min
Acupuncture_Needle
Needle_Manufacturer
Needle_Depth
0.25×0.40 mm
Dongbang Acupuncture, Seongnam, Korea
-
Description Stimulation was applied with a biphasic waveform current which is a compressional wave that combines an interrupted wave and a continuous wave, in triangular form at a frequency of 50 Hz,24 and was delivered via alligator clips connected to acupuncture needles inserted at Jia-ji (Ex-B2, L3/L5; bilaterally).
Anesthesia Method
GA
Clinical Trial Type
random
Adverse Effects
No adverse events were reported in this study.
Contraindications
Conditions inappropriate or unsafe for EA (eg, due to haemorrhagic disease, clotting disorder, history of having received anticoagulant therapy within the preceding 3 weeks, severe diabetes with risk of infection or severe cardiovascular disease)
Effector
In both treatment groups, there were statistically significant improvements in VAS scores for back pain, and ODI and EQ-5D scores at 8 weeks compared with baseline (table 2). However, there were no statistically significant differences in the VAS score for back pain (p=0.0675) and in the EQ-5D (p=0.5151) score between the two treatment groups at 8 weeks (table 2). There was a statistically significant decrease in the ODI after 8 weeks in the EA plus UC group when compared with the UC alone group (p=0.0081; table 2). In the ITT analysis (n=39), the proportion of responders, defined as participants with ≥50% pain relief on the 100 mm VAS for pain intensity, was 33.3% (n=6) in the EA plus UC group (n=18) and 9.5% (n=2) in the UC alone group (n=21); the difference between the groups was not statistically significant (p=0.1123; table 2).
Electroacupuncture as a complement to usual care for patients with non-acute low back pain after back surgery: a pilot randomised controlled trial.
Abstract
OBJECTIVES: The aim of this pilot study was to estimate the sample size for a large pragmatic study of the comparative effectiveness of electroacupuncture (EA) for low back pain (LBP) after back surgery. DESIGN: A randomised, active-controlled, assessor-blinded trial. PARTICIPANTS: Patients with recurrent or persistent LBP, defined as a Visual Analogue Scale (VAS) score of >/=50 mm, with or without leg pain after back surgery. INTERVENTIONS: Patients were randomised to an EA plus usual care (UC) group or to a UC alone group at a 1:1 ratio. Patients assigned to each group received UC, including drug therapy, physical therapy and back pain education, twice a week for 4 weeks; those assigned to the EA plus UC group additionally received EA. OUTCOME MEASURES: The primary outcome was severity of LBP as measured by VAS. Secondary outcomes included back pain-related disability, assessed using the Oswestry Disability Index (ODI) and quality of life, assessed using the EuroQol Five Dimensions (EQ-5D) questionnaire. Statistical analysis was performed using paired and independent t-tests. A p value of <0.05 was considered statistically significant. RESULTS: Thirty-nine patients were allocated to receive EA plus UC (n=18) or UC alone (n=21). There was no statistically significant difference in VAS or EQ-5D scores between the two groups, but there was a significant decrease in ODI scores (p=0.0081). Using G*Power, it was calculated that 40 participants per group would be needed for a future trial according to VAS scores. Considering for a 25% dropout rate, 108 participants (54 per group) would be needed. CONCLUSIONS: A future trial addressing the risk of bias and including the estimated sample size would allow for better clinical assessment of the benefits of EA plus UC in treatment of patients with non-acute pain after back surgery. TRIAL REGISTRATION NUMBER: NCT01966250; Results."
Souce
BMJ Open. 2018 May 17;8(5):e018464. doi: 10.1136/bmjopen-2017-018464.
