Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
Acupuncture for Acute Non-Specific Low Back Pain: A Randomized, Controlled, Placebo Trial
Hasegawa, Tatiana Molinas, Baptista, Andreia Salvador, de Souza, Marcelo Cardoso, Yoshizumi, Alexandre Massao, Natour, Jamil
Acute non-specific low back pain (LBP) is defined as an episode of low back pain, not attributed to a recognizable or known specific disease, persisting for less than 6 weeks. Evaluate the effectiveness of Yamamoto's method of acupuncture on pain, functional status and quality of life using on patients with acute non-specific LBP.
80 patients with acute non-specific LBP were invited to participate in a randomized and blinded controlled clinical trial. The patients were randomized to an intervention-group (submitted to five real acupuncture sessions) or a control-group (placebo-submitted to five non-penetrating acupuncture sessions). The patients were evaluated by a blinded examiner in the beginning (T0), 3 (T3), 7 (T7), 14 (T14), 21(T21) and 28 (T28) days after intervention, using the following outcomes: visual analogue scale (VAS) for pain before (last week) and after intervention, Roland-Morris questionnaire (RM), SF-36, patient improvement by visual scale (LIKERT) and number of anti-inflammatory taken. The number of visits to the doctor was considered as co-interventions. Following treatment, patients were asked whether they thought they had undergone real acupuncture or the placebo treatment. The primary outcome was to detect a 2-point reduction in pain VAS; the minimal clinically important difference (MCID) for the RM scale was a reduction of 2.5 points. Statistical analysis was performed using the Student's t-test to compare the baseline characteristics and analysis of variance (ANOVA) with repeated measurements to assess inter/intra-group changes.
The groups were homogeneous at baseline. 80 patients completed the study and intention-to-treat analysis was performed. Until day 14, the only difference found between groups (p=0.03) was on VAS for pain before and after intervention what we call of immediate improvement; or all the other outcomes both groups improved and there was no significant difference between them. After 14 days the intervention group showed a significant improvement (p<0.05) in last week pain-VAS; RM; bodily pain and vitality domains of SF-36. Physical function domain of SF-36 revealed a meaningful difference after 21days, in the intervention-group (p<0.001). There was also a reduction in anti-inflammatory tables intake in the intervention-group (p=0.002). There was no meaningful differences between the groups concerning the variables LIKERT (p=0.67) and number of visits to the doctor (p=0.33). Thirty-six (90%) patients in the placebo group believed they had received real acupuncture, thereby supporting the credibility of non-penetrating placebo used in this study.
Acupuncture was more effective than placebo regarding decreasing pain and anti-inflammatory intake and improving functional status, bodily pain, vitality and physical function domains of SF-36. Acupuncture was ineffective regarding the others domains of SF-36, Likert scale and number of visits to the doctor.
To cite this abstract, please use the following information:
Hasegawa, Tatiana Molinas, Baptista, Andreia Salvador, de Souza, Marcelo Cardoso, Yoshizumi, Alexandre Massao, Natour, Jamil; Acupuncture for Acute Non-Specific Low Back Pain: A Randomized, Controlled, Placebo Trial [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1497