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 |
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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 |
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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 |
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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) |
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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. |
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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 |