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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01124955
First received: May 13, 2010
Last updated: June 13, 2011
Last verified: November 2009
History of Changes
  Purpose

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 Intervention
Low Back Pain
 Other: Acupuncture
Other: Non-penetrating acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Acute Nonspecific Low Back Pain: a Randomized, Controlled, Double-blind, Placebo Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Pain Assessed on a 10-point Numeric Pain Scale [ Time Frame: days 0, 3, 7, 14, 21 and 28 ] [ Designated as safety issue: Yes ]
    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:
  • Roland-Morris Disability Questionnaire (RM) [ Time Frame: days 0, 3, 7, 14, 21 and 28 ] [ Designated as safety issue: Yes ]

    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).


  • Quality of Life Assessed on the SF-36 [ Time Frame: Days 0, 3, 7, 14, 21 and 28 ] [ Designated as safety issue: Yes ]
    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.

  • Likert Improvement Assessment Scale [ Time Frame: Days 0, 3, 7, 14 and 21 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Anti-inflammatory Tablets Taken [ Time Frame: Days 3,7,14,21 and 28 ] [ Designated as safety issue: Yes ]
    Number of 50 mg sodium diclofenac pills taken per day


Enrollment: 80
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124955

Locations
Brazil
Tatiana Hasegawa
Sao Paulo, SP, Brazil, 04011060
Tatiana Hasegawa
São Paulo, Brazil, 04011-060
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Jamil Natour, MD,PhD Federal University of São Paulo
  More Information

Publications:

Responsible Party: Tatiana Molinas Hasegawa, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01124955     History of Changes
Other Study ID Numbers: FDAAAAU
Study First Received: May 13, 2010
Results First Received: August 9, 2010
Last Updated: June 13, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
treatment
acupuncture
spine

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013