Acupuncture Using Yamamoto's Method for the Treatment of Acute Nonspecific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The aim of the present study is to assess the effectiveness of acupuncture using Yamamoto's
      method for the treatment of ANLBP using the following outcomes:pain,functional
      capacity,quality of life and number of 50 mg sodium diclofenac pills taken per day.
    

Detailed description: 
      A randomized, controlled, double-blind, prospective trial is being conducted involving 80
      patients with low-back pain defined as pain and discomfort localised bellow the costal margin
      and above the inferior gluteal folds, for a period of less than 30 days and unrelated to any
      specific etiological factors. Patients are being recruited from the university hospital of
      the Federal University of Sao Paul (UNIFESP)and exams were carried out by a rheumatologist.
      The patients are randomly assigned to either intervention group (IG) and are submitted to
      five acupuncture sessions or placebo group (PG) and are submitted to five non-penetrating
      acupuncture sessions. Both groups are recommended to take 50 mg of sodium diclofenac every
      eight hours for lumbar pain, if needed and record the number of pills on a standardized form.

      The patients are instructed not to use other medications or therapies for low-back pain
      during the study.The IG are submitted to acupuncture by a physician acupuncturist with eight
      years experience in the technique. Five acupuncture session are performed at baseline, D3,
      D7, D14 and D21. Specific needles for scalp acupuncture and tubes that guide these needles,
      called mandrels are unpacked in front of the patient. The stainless steel needles: 0.20 x 13
      mm, sterilized and disposable.Sessions last 20 minutes. The patient remain seated, using a
      hat with a central orifice exposing the area to receive the needles. The hat has a wide brim
      to keep the patient blinded for the procedures. The needle penetrates the skin at an
      approximately 15º angle and a depth of 0.3 to 0.5 cm. The PG are submitted to five placebo
      acupuncture session performed by the same acupuncturist with same material and hat, but
      penetration did not occur and only the mandrel came into contact with the skin. All patients
      are blind to which procedure they are receiving. The basic points D, H and I and kidney,
      bladder and liver points of Yamamoto's method are used as standard treatment to ANLBP for the
      both groups.

      Evaluations: The IG and PG are evaluated six times between baseline and Day 28 immediately
      before and after each acupuncture session. Outcome measures are recorded by a single assessor
      blinded to group allocation.

      D0: baseline; D3: three days after baseline; D7: seven days after baseline; D14: fourteen
      days after baseline; D21: twenty-one days after baseline and D28: twenty-eight days after
      baseline.

      Losses: Participants absent from more than three acupuncture sessions and evaluations are
      considered losses.

      Placebo credibility: At the end of the study, participants are asked about which group they
      believed they belonged.

      Sample size: To achieve an improvement in VAS pain of 2.0 point, with a significance of 0.05,
      and a power of 0.90, a minimum of 40 patients per group is necessary as a previous
      compensation for the possible 20% loss at follow-up.

      Statistics: An intention-to-treat analysis are performed, using the
      last-observation-carried-forward method. A level of significance of p < 0.05 (2-tailed tests)
      are accepted for the trial. For normally distributed data, the variables are analysed using
      repeated-measures analysis of variance (ANOVA). The analysis are performed between groups
      (acupuncture versus non-penetrating acupuncture; between subjects factors) and over the time
      (baseline, 3, 7, 14, 21 and 28 days; within subjects factors). Categorical data measured over
      time are analysed using repeated-measures analyses of variance (ANOVA) for categorical data.
      A 95% confidence interval (95% CI) are used. The Student's t-test are used to compare
      numerical variables with normal distribution at one time and the chi-square test or Fisher's
      exact test are used to determine differences in rates of improvement between the two groups.
      The Kappa index are used to determine agreement on the LIKERT assessment between patient and
      assessor. All tests are performed using SPSS version 15.0 and MINITAB 14.0
    

Intervention name(s): Acupuncture; Non-penetrating acupuncture
Intervention type(s): Other; Other
Intervention description(s): The intervention group (IG) are submitted to five acupuncture sessions using Yamamoto New Scalp Acupuncture(YNSA); The placebo group (PG) are submitted to five non-penetrating acupuncture sessions using YNSA.
Other intervention name(s): Real acupuncture; Placebo acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: treatment; acupuncture; spine