To Assess the Effectiveness of Acupuncture Using Yamamoto's Method for the Treatment of Acute Nonspecific Low Back Pain (ANLBP)

2014-08-27 03:13:39 | BioPortfolio


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.


A randomized, controlled, double-blind, prospective trial is being conducted involving 70 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

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Low Back Pain




Tatiana Hasegawa
São Paulo




Federal University of São Paulo

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:39-0400

Clinical Trials [1938 Associated Clinical Trials listed on BioPortfolio]

Acupuncture for Back and Neck Pain in an Emergency Room Setting

This study aims to examine the efficacy of an Integrative approach utilizing Acupuncture as an add-on therapy for the treatment back and neck pain in an emergency department setting Acupu...

Battlefield Acupuncture for the Treatment of Low Back Pain in the Emergency Department

The purpose of this study is to study acupuncture for the treatment of low back pain in the emergency department. Current treatments for low back pain in the emergency department generally...

Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupunc...

Suture Embedding Acupuncture for Chronic Low Back Pain

Chronic low back pain (cLBP) is a common public health issue, and it is one of the main causes of disability among adults of working age. Suture embedding acupuncture is one of the most of...

Clinical Research on the Efficacy of Acupuncture Treatment in Chronic Low Back Pain

This research is planned to build a basis about effect of acupuncture for chronic low back pain with economical efficacy. It is consisted with two sub research. First,clinical research to...

PubMed Articles [5173 Associated PubMed Articles listed on BioPortfolio]

Efficacy and safety of electromagnetic acupuncture using an electromagnetic therapy stimulator (Whata153) for the treatment of chronic low back pain: Study protocol for a single-center, parallel-arm, randomized clinical trial.

Chronic low back pain is one of the major conditions causing serious personal and social difficulties in modern society. There are several noninvasive therapies for chronic low back pain; however, the...

Acupuncture for chronic uncomplicated musculoskeletal pain associated with the spine: A systematic review protocol.

Chronic uncomplicated neck pain, back pain, and lower back pain, with incidences of 18%, 17.7% and 36%, respectively. Although these three conditions occur in different parts of the body, we can summa...

Classical Massage and Acupuncture in Chronic Back Pain - Non-Inferiority Randomised Trial.

Currently, there is a need for scientific evidence on the efficacy of classical massage therapy for chronic, unspecific back pain, especially for the improvement in functional impairment and long-term...

Acupuncture treatment: multidimensional assessment of low back pain in pregnant women.

To evaluate the effects of acupuncture in the treatment of low back pain in pregnant women in the second and third trimesters of pregnancy.

Acupuncture for treatment of depressive disorders in pain diseases.

Therapy with acupuncture as a part of Traditional Chinese Medicine (TCM) is increasingly being used as an alternative or complementary method. The regular diagnostic processes and conventional therap...

Medical and Biotech [MESH] Definitions

Acupuncture therapy by inserting needles in the ear. It is used to control pain and for treating various ailments.

A condition of persistent pain and discomfort in the BACK and the LEG following lumbar surgery, often seen in patients enrolled in pain centers.

Pain associated with OBSTETRIC LABOR in CHILDBIRTH. It is caused primarily by UTERINE CONTRACTION as well as pressure on the CERVIX; BLADDER; and the GASTROINTESTINAL TRACT. Labor pain mostly occurs in the ABDOMEN; the GROIN; and the BACK.

A type of massage in which finger pressure on specific body sites is used to promote healing, relieve fatigue, etc. Although the anatomical locations are the same as the ACUPUNCTURE POINTS used in ACUPUNCTURE THERAPY (hence acu-), no needle or other acupuncture technique is employed in acupressure. (From Random House Unabridged Dictionary, 2d ed). Shiatsu is a modern outgrowth that focuses more on prevention than healing.

Analgesia produced by the insertion of ACUPUNCTURE needles at certain ACUPUNCTURE POINTS on the body. This activates small myelinated nerve fibers in the muscle which transmit impulses to the spinal cord and then activate three centers - the spinal cord, midbrain and pituitary/hypothalamus - to produce analgesia.

More From BioPortfolio on "To Assess the Effectiveness of Acupuncture Using Yamamoto's Method for the Treatment of Acute Nonspecific Low Back Pain (ANLBP)"

Quick Search


Relevant Topics

Alternative Medicine
Complementary and alternative medicine (CAM) is the term for medical products and practices that are not part of standard care. Standard care is what medical doctors, doctors of osteopathy, and allied health professionals, such as nurses and physical the...

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Searches Linking to this Trial