PMID- 18534326 OWN - NLM STAT- MEDLINE DCOM- 20080917 LR - 20080606 IS - 0965-2299 (Print) IS - 0965-2299 (Linking) VI - 16 IP - 3 DP - 2008 Jun TI - Acupuncture for acute non-specific low back pain: a pilot randomised non-penetrating sham controlled trial. PG - 139-46 LID - 10.1016/j.ctim.2007.03.001 [doi] AB - OBJECTIVE: A pilot study to assess the feasibility of a trial to investigate the efficacy of acupuncture compared to placebo needling for the treatment of acute low back pain (LBP). As part of this, the study was designed to establish the credibility of the placebo control, and to provide data to inform a power analysis to determine numbers for a future trial. STUDY DESIGN: A pilot patient and assessor blinded randomized controlled trial. SETTING: Primary care health centre facility, South and East Belfast Trust, Northern Ireland. PATIENTS: Patients from the physiotherapy waiting list (n=48) with LBP of less than 12 weeks duration. OUTCOME MEASURES: Roland and Morris Disability Questionnaire (RMDQ), Visual Analogue Scale (VAS), medication use and an exit questionnaire were completed at baseline, end of treatment, and at 3 months follow up. RESULTS: Ninety-four percent (45/48) of patients completed assigned treatment, 83% (40/48) completed 3 months follow-up. The sham needle used here proved to be credible: 91.7% in the placebo group believed they had received acupuncture, compared to 95.8% in the verum acupuncture group. Differences in baseline characteristics were accounted for using ANCOVA. There was no significant difference between groups on the RMDQ over time. For pain, the only statistically significant difference was at the 3 months follow up (worst VAS, point estimate, 18.7, 95% CI 1.5-36.0, p=0.034). The majority of patients were taking some form of analgesic medication for LBP at the start of treatment (n=44; 92%), and at the end of treatment the verum acupuncture group were taking significantly fewer tablets of pain control medication (mean (S.D.): 1.0+/-0.3) than the placebo group (mean (S.D.): 4.2+/-0.6, p<0.05). Based upon these data, power analysis (power=90%, alpha=0.05, minimal clinically important difference (MCID) for RMDQ=2.5 points) indicated that 120 participants (60 per group) would be needed to complete an adequately powered randomized controlled trial. CONCLUSIONS: This study has demonstrated the feasibility of a randomized controlled trial of penetrating needle acupuncture compared to a non-penetrating sham for the treatment of acute LBP in primary care; 120 participants would be required in a fully powered trial. The placebo needle used in this study proved to be a credible form of control. FAU - Kennedy, S AU - Kennedy S AD - Health and Rehabilitation Sciences Research Institute, School of Health Sciences, University of Ulster, Northern Ireland, United Kingdom. FAU - Baxter, G D AU - Baxter GD FAU - Kerr, D P AU - Kerr DP FAU - Bradbury, I AU - Bradbury I FAU - Park, J AU - Park J FAU - McDonough, S M AU - McDonough SM LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20070427 PL - Scotland TA - Complement Ther Med JT - Complementary therapies in medicine JID - 9308777 SB - IM MH - *Acupuncture Therapy MH - Adolescent MH - Adult MH - Aged MH - Double-Blind Method MH - Feasibility Studies MH - Female MH - Humans MH - Low Back Pain/*therapy MH - Male MH - Middle Aged MH - Patient Satisfaction MH - Pilot Projects EDAT- 2008/06/07 09:00 MHDA- 2008/09/18 09:00 CRDT- 2008/06/07 09:00 PHST- 2006/07/28 00:00 [received] PHST- 2007/02/27 00:00 [revised] PHST- 2007/03/07 00:00 [accepted] PHST- 2008/06/07 09:00 [pubmed] PHST- 2008/09/18 09:00 [medline] PHST- 2008/06/07 09:00 [entrez] AID - S0965-2299(07)00035-0 [pii] AID - 10.1016/j.ctim.2007.03.001 [doi] PST - ppublish SO - Complement Ther Med. 2008 Jun;16(3):139-46. doi: 10.1016/j.ctim.2007.03.001. Epub 2007 Apr 27.