Acupuncture for Acute Nonspecific Low Back Pain: a Randomized, Controlled, Double-blind, Placebo Trial

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.