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. 2020 Dec 11;2020(12):CD013814. doi: 10.1002/14651858.CD013814

Tsukayama 2002.

Study characteristics
Methods Two‐arm RCT
Number analyzed/randomized: 19/20
Statistical analysis: analyzed as assigned group; repeated ANOVA; power analysis not conducted
Funding source: grant from the Foundation for Training and Licensure Examination in Anma‐Massage‐Acupressure, Acupuncture and Moxibustion and the Tsukuba College of Technology
Ethical approval and informed consents obtained
Participants Participant recruitment: by leaflets in Tsukuba, Japan
Setting: at Tsukuba College of Technology Clinic, Japan
Inclusion criteria: 1) LBP without sciatica; 2) at least a 2‐week history of LBP; (3) > 20 years old
Exclusion criteria: 1) radiculopathy or neuropathy in the lower extremity; 2) fracture, tumor, infection, or internal disease; 3) other general health problems; 4) other conflicting or ongoing treatments
Mean age: 44.9 years
Gender (female): 84%
Pain duration (mean): 8.3 years
Pain intensity (mean ± SD): not reported
Interventions 1) GROUP 1: electroacupuncture (EA, semi‐standardized)
Acupuncture points: 8 points in total; BL23 and BL26 most frequently used
Depth: the average insertion depth was approximately 20 mm
De Qi: 15 min stimulation with a frequency of 1Hz
Sessions: 4 sessions (2/week for 2 weeks)
Acupuncturist experience: conservative physical therapy currently practiced in Japan
After electroacupuncture treatment at each session, the press tack needles (Seirin Jr®: Seirin Kasei Co. Ltd., Japan) were inserted at four of the eight points chosen, left in situ for several days, and then removed.
2) GROUP 2: TENS
Gel type disposable electrodes of size 20 x 30 mm were used for eight points. Electrostimulation was applied and muscle contraction was observed. After each session, a poultice containing methyl salicylic acid, menthol, and antihistamine was prescribed for home application between treatments to the low back region.
Co‐intervention: not reported
Duration of treatment: 2 weeks
Duration of follow‐up: immediately post‐treatment
Outcomes 1) Pain intensity: VAS (0 to 100)
2) Pain‐related disability: subjective symptoms and restriction of daily activities items of Japanese Orthopaedic Association (JOA) score, higher values = better
Assessment time: immediately post‐treatment
Costs: NR
Adverse effects: 1) EA group: transient aggravation of LBP (n = 1), discomfort due to press tack needles (n = 1), pain on needle insertion (n = 1) and small subcutaneous bleeding (10 mm in diameter, n = 1); 2) TENS group: transient aggravation of back pain (n = 1), transient fatigue (n = 1), itching with electrode (n = 1)
Notes Conclusion: "In the present preliminary study, although some placebo effect may be included, EA showed more effectiveness than TENS in short‐term treatment of LBP."
Language: English
Mean and SD data of VAS and JOA score were obtained from Figures.
For results, see comparison 4.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer software‐generated random numbers
Allocation concealment (selection bias) Low risk Sealed envelopes were used.
Blinding of participants (performance bias) 
All outcomes Unclear risk Not reported
Blinding of personnel /care providers (performance bias) 
All outcomes High risk Not possible
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Blinded assessor was mentioned; otherwise outcomes seemed to be participant‐reported.
Incomplete outcome data (attrition bias)
All outcomes Low risk There was a 5% dropout rate, and acceptable withdrawal reasons.
Intention‐to‐treat‐analysis (attrition bias) Low risk Subjects with available data were analyzed according to the assigned group.
Selective reporting (reporting bias) Low risk All outcomes were reported.
Group similarity at baseline (selection bias) Unclear risk The risk factors were similar between the two groups except for VAS (pain).
Co‐interventions (performance bias) Unclear risk TENS group also used a poultice to the low back region.
Compliance bias (performance bias) Low risk Comparable compliance between groups
Timing of outcome assessments (detection bias) Low risk Same time
Other bias Low risk Not identified