There is some evidence for the efficacy of acupuncture in chronic low-back pain (LBP), but it remains unclear whether acupuncture is superior to placebo. In a randomized, blinded, placebo-controlled trial, we evaluated the effect of traditional acupuncture in chronic LBP. A total of 131 consecutive out-patients of the Department of Orthopaedics, University Goettingen, Germany, (age=48.1 years, 58.5% female, duration of pain: 9.6 years) with non-radiating LBP for at least 6 months and a normal neurological examination were randomized to one of three groups over 12 weeks. Each group received active physiotherapy over 12 weeks. The control group (n=46) received no further treatment, the acupuncture group (n=40) received 20 sessions of traditional acupuncture and the sham-acupuncture group (n=45) 20 sessions of minimal acupuncture. Changes from baseline to the end of treatment and to 9-month follow-up were assessed in pain intensity and in pain disability, and secondary in psychological distress and in spine flexion, compared by intervention groups. Acupuncture was superior to the control condition (physiotherapy) regarding pain intensity (P=0.000), pain disability (P=0.000), and psychological distress (P=0.020) at the end of treatment. Compared to sham-acupuncture, acupuncture reduced psychological distress (P=0.040) only. At 9-month follow-up, the superiority of acupuncture compared to the control condition became less and acupuncture was not different to sham-acupuncture. We found a significant improvement by traditional acupuncture in chronic LBP compared to routine care (physiotherapy) but not compared to sham-acupuncture. The trial demonstrated a placebo effect of traditional acupuncture in chronic LBP.
TVT position relative to the patient's urethra seems to play a role in treatment outcome. Outcome was best in patients with dynamic change in tape shape during straining and location of the tape at the junction between the lower and middle urethra and at least 3 mm from the urethral lumen.
Introduction and hypothesisThis study evaluates the relevance of the tape position and change in shape (tape functionality) under in vivo conditions for mid-term outcome.MethodsChanges in the sonographic tension-free vaginal tape (TVT) position relative to the percentage urethral length and the tape–urethra distance were determined after 6 and 48 months in 41 women with stress urinary incontinence.ResultsAt 48 months, 76% (31/41) of women were cured, 17% (7/41) were improved, and 7% (3/41) were failures. Disturbed bladder voiding was present in 12% (5/41), de novo urge incontinence in 7% (3/41). The median TVT position was at 63% of urethral length. Median tape–urethra distance was 2.7 mm, ranging from 2.9 mm in continent patients without complications to 1.1 mm in those with obstructive complications. Patients with postoperative urine loss had a median distance of 3.9 mm. The tape was stretched at rest and C-shaped during straining in 15 of 41 women (37%) at 48 months (all continent). Patients with this tape functionality at 6 months were also cured at 48 months in 86% of cases (19/22), and only 14% (3/22) showed recurrent incontinence.ConclusionsMid-term data suggest an optimal outcome if the tape is positioned at least 2 mm from the urethra at the junction of the middle and distal thirds. Patients with optimal tape functionality at 6 months are likely to show mid-term therapeutic success.
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