Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01124955
Recruitment Status : Completed
First Posted : May 18, 2010
Results First Posted : June 13, 2011
Last Update Posted : June 15, 2011
Information provided by:
Federal University of São Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Acupuncture Other: Non-penetrating acupuncture Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Acute Nonspecific Low Back Pain: a Randomized, Controlled, Double-blind, Placebo Trial
Study Start Date : November 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Intervention Group
Patients receive 5 sessions of real acupuncture. The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
Other: Acupuncture
The intervention group (IG) are submitted to five acupuncture sessions using Yamamoto New Scalp Acupuncture(YNSA)
Other Name: Real acupuncture

Placebo Comparator: Non-penetrating acupuncture
The placebo group (PG) are submitted to five non-penetrating acupuncture sessions using YNSA.
Other: Non-penetrating acupuncture
The placebo group (PG) are submitted to five non-penetrating acupuncture sessions using YNSA.
Other Name: Placebo acupuncture

Primary Outcome Measures :
  1. Pain Assessed on a 10-point Numeric Pain Scale [ Time Frame: days 0, 3, 7, 14, 21 and 28 ]
    The primary outcome is a visual analog pain scale (VAS), graded in centimeters from 0 to 10 (0=no pain; 10=worst imaginable pain), measured before (VAS 1) and after (VAS 2) the acupuncture session.

Secondary Outcome Measures :
  1. Roland-Morris Disability Questionnaire (RM) [ Time Frame: days 0, 3, 7, 14, 21 and 28 ]

    Secondary outcomes includes the Roland-Morris Disability Questionnaire (RM) for the assessment of functional capacity, with 24 items on low-back pain: higher scores denote poorer functional capacity.

    0: better functional capacity 24: poorer functional capacity Range of score: the highest is 24 (poorer functional capacity) and lowest scores is 0 (better functional capacity).

  2. Quality of Life Assessed on the SF-36 [ Time Frame: Days 0, 3, 7, 14, 21 and 28 ]
    Questionnaire Short-form-36 is a widely used generic health status questionnaire, validated for Portuguese with eight components and each components with scores from 0 to 100: higher scores denote greater quality of life.

  3. Likert Improvement Assessment Scale [ Time Frame: Days 0, 3, 7, 14 and 21 ]
    Likert improvement assessment scale is based on the patient's opinion (LIKERT P) and assessor's opinion (LIKERT A), categorized in 1=MB (much better), 2=SB (slightly better), 3=NC (no change), 4=SW (slightly worse) and 5=MW (much worse). This scale was was applied to each day of assessment. The numbers in the category titles represent the different days.

  4. Number of Anti-inflammatory Tablets Taken [ Time Frame: Days 3,7,14,21 and 28 ]
    Number of 50 mg sodium diclofenac pills taken per day

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female
  • Aged 18 to 65 years
  • Seeking medical assistance for nonspecific low-back pain
  • Score of 4 to 8 cm on the pain scale (0 to 10 cm)
  • Agreed to participate and signed term of informed consent

Exclusion Criteria:

  • Patients with a diagnostic investigation of secondary causes as spondyloarthropathy, infection, tumor or fracture
  • Sciatica lumbar pain
  • Previous surgery on spinal column
  • Litigation
  • Having changed physical activity or underwent acupuncture or physical therapy in previous three months,
  • Having previously undergone scalp acupuncture
  • Pregnancy
  • Contraindication for anti-inflammatory agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01124955

Layout table for location information
Tatiana Hasegawa
Sao Paulo, SP, Brazil, 04011060
Tatiana Hasegawa
São Paulo, Brazil, 04011-060
Sponsors and Collaborators
Federal University of São Paulo
Layout table for investigator information
Study Chair: Jamil Natour, MD,PhD Federal University of São Paulo

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Tatiana Molinas Hasegawa, Federal University of Sao Paulo Identifier: NCT01124955     History of Changes
Other Study ID Numbers: FDAAAAU
First Posted: May 18, 2010    Key Record Dates
Results First Posted: June 13, 2011
Last Update Posted: June 15, 2011
Last Verified: November 2009

Keywords provided by Federal University of São Paulo:

Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms