Text Size

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
Results First Received: August 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Other: Acupuncture
Other: Non-penetrating acupuncture

  Participant Flow
  Show Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Acupuncture The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
Placebo Group Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
Total Total of all reporting groups

Baseline Measures
    Acupuncture     Placebo Group     Total  
Number of Participants  
[units: participants]
 		  40     40     80  
Age  
[units: participants]
 		     
Between 18 and 65 years     40     40     80  
Age  
[units: years]
Mean ± Standard Deviation 		  47  ± 9.8     43.9  ± 10.9     45.4  ± 10.3  
Gender  
[units: participants]
 		     
Female     25     26     51  
Male     15     14     29  
Region of Enrollment  
[units: participants]
 		     
Brazil     40     40     80  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pain Assessed on a 10-point Numeric Pain Scale   [ Time Frame: days 0, 3, 7, 14, 21 and 28 ]
  Show Outcome Measure 1

2.  Secondary:   Roland-Morris Disability Questionnaire (RM)   [ Time Frame: days 0, 3, 7, 14, 21 and 28 ]
  Show Outcome Measure 2

3.  Secondary:   Quality of Life Assessed on the SF-36   [ Time Frame: Days 0, 3, 7, 14, 21 and 28 ]
  Show Outcome Measure 3

4.  Secondary:   Likert Improvement Assessment Scale   [ Time Frame: Days 0, 3, 7, 14 and 21 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Anti-inflammatory Tablets Taken   [ Time Frame: Days 3,7,14,21 and 28 ]
  Show Outcome Measure 5


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Tatiana Molinas Hasegawa
Organization: Federal University of São Paulo
phone: 55 115576 4239
e-mail: tatianamolinas@hotmail.com


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