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Efficacy and safety of auriculopressure for primary care patients with chronic non-specific spinal pain: a multicentre randomised controlled trial [with consumer summary] |
Vas J, Modesto M, Aguilar I, da Silva Goncalo C, Rivas-Ruiz F |
Acupuncture in Medicine 2014 Jun;32(3):227-235 |
clinical trial |
9/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Chronic uncomplicated musculoskeletal pain in the spine (cervical, thoracic or lumbar) is highly prevalent and may severely limit the daily activities of those affected by it. OBJECTIVE: To evaluate the efficacy and safety of treatment with auriculopressure applied to patients with non-specific spinal pain. METHODS: A multicentre randomised controlled trial with two parallel arms (true auriculopressure (TAP) and placebo auriculopressure (PAP)) was performed. The intervention phase lasted 8-weeks and outcomes were measured 1-week after the last intervention (T1) and 6-months after baseline (T2). The primary outcome measure was change in pain intensity according to a 100-mm visual analogue scale (pain VAS) at T1. Secondary outcome measures were the Lattinen index, the McGill Pain Questionnaire and the SF-12 health-related quality of life scale (Spanish version in every case). RESULTS: There were 265 participants (TAP group, n = 130; PAP group, n = 135). Pain was most frequently located in the upper back (55.1%, n = 146), followed by the lower back (25.3%, n = 67) and the dorsal area (12.5%, n = 33). Nineteen patients (7.2%) reported pain affecting the entire spine. There were statistically significant differences between TAP and PAP in the change in the pain VAS at T1 of 10-mm (95% CI 2.8 to 17.3, p = 0.007) and in the change in the pain VAS at T2 of 7.2-mm (95% CI 0.02 to 14.3, p = 0.049) in favour of TAP. We also observed a statistically significant difference of 3.4 points in the physical component of the SF-12 in favour of TAP at T2 (95% CI 0.45 to 6.3, p = 0.024). No severe adverse effects were detected or reported during treatment. CONCLUSIONS: The application of auriculopressure in patients with non-specific spinal pain in primary healthcare is effective and safe, and therefore should be considered for inclusion in the portfolio of primary healthcare services. TRIAL REGISTRATION NUMBER: ISRCTN01897462.
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