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
  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:


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 April 16, 2014