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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
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
100 patients were recruited from the university hospital of the Federal University of São Paul (UNIFESP), from November 2009 to June 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
80 patients were randomized during the study.

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).

Participant Flow:   Overall Study
    Acupuncture     Placebo Group  
STARTED     40     40  
COMPLETED     40     40  
NOT COMPLETED     0     0  



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

Measure Type Primary
Measure Title Pain Assessed on a 10-point Numeric Pain Scale
Measure Description 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.
Time Frame days 0, 3, 7, 14, 21 and 28  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat analysis (ITT)

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).

Measured Values
    Acupuncture     Placebo Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Number of cm Analyzed  
[units: cm]
 		  40     40  
Pain Assessed on a 10-point Numeric Pain Scale  
[units: cm]
Mean ± Standard Deviation 		   
Day 0     6.55  ± 1.4     6.68  ± 1.44  
Day 3     4.63  ± 2.23     5.13  ± 2.21  
Day 7     3.83  ± 2.61     4.4  ± 2.09  
Day 14     2.8  ± 2.27     3.95  ± 2.19  
Day 21     2.49  ± 2.4     4.18  ± 2.52  
Day 28     1.98  ± 2.12     3.38  ± 2.26  

No statistical analysis provided for Pain Assessed on a 10-point Numeric Pain Scale



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

Measure Type Secondary
Measure Title Roland-Morris Disability Questionnaire (RM)
Measure Description

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).
Time Frame days 0, 3, 7, 14, 21 and 28  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat analysis (ITT)

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).

Measured Values
    Acupuncture     Placebo Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Number of scores on a scale Analyzed  
[units: scores on a scale]
 		  40     40  
Roland-Morris Disability Questionnaire (RM)  
[units: scores on a scale]
Mean ± Standard Deviation 		   
Day 0     14.9  ± 4.0     14.6  ± 4.8  
Day 3     10.3  ± 5.4     12.4  ± 4.5  
Day 7     8.1  ± 5.5     10.2  ± 5.3  
Day14     5.3  ± 4.6     8.9  ± 5.2  
Day 21     4.40  ± 4.4     8.5  ± 6.2  
Day 28     4.1  ± 4.7     8.0  ± 6.1  


Statistical Analysis 1 for Roland-Morris Disability Questionnaire (RM)
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0,05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Roland-Morris Disability Questionnaire (RM)
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0,05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Quality of Life Assessed on the SF-36
Measure Description 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.
Time Frame Days 0, 3, 7, 14, 21 and 28  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat analysis (ITT)

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).

Measured Values
    Acupuncture     Placebo Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Number of scale Analyzed  
[units: scale]
 		  40     40  
Quality of Life Assessed on the SF-36  
[units: scores on a scale]
Mean ± Standard Deviation 		   
Day 0 Functional Capacity     46.4  ± 22.7     55.8  ± 19.2  
Day 3 Functional Capacity     58.5  ± 25.7     60.6  ± 19.6  
Day 7 Functional Capacity     68.8  ± 22.3     66.6  ± 17.1  
Day 14 Functional Capacity     78.6  ± 20.8     71.6  ± 20.8  
Day 21 Functional Capacity     81.8  ± 17.6     71.4  ± 21.7  
Day 28 Functional Capacity     84.0  ± 19.8     70.9  ± 22.5  
Day 0 limitation in physical aspects     18.1  ± 26.5     16.3  ± 26.3  
Day 3 limitation in physical aspects     35.6  ± 37.9     30.6  ± 33.2  
Day 7 limitation in physical aspects     53.1  ± 39.7     43.8  ± 40.7  
Day 14 limitation in physical aspects     70.6  ± 36.2     55.0  ± 35.0  
Day 21 limitation in physical aspects     75.6  ± 33.7     56.3  ± 39.9  
Day 28 limitation in physical aspects     78.8  ± 31.8     55.8  ± 38.3  
Day 0 Pain     27.6  ± 17.9     28.8  ± 19.1  
Day 3 Pain     46.1  ± 24.9     44.8  ± 19.4  
Day 7 Pain     54.8  ± 20.0     51.5  ± 21.4  
Day 14 Pain     64.9  ± 20.3     53.6  ± 19.2  
Day 21 Pain     69.3  ± 22.7     54.6  ± 24.7  
Day 28 Pain     67.8  ± 26.1     56.5  ± 23.4  
Day 0 General Health State     54.2  ± 25.7     56.5  ± 24.9  
Day 3 General Health State     60.5  ± 23.0     62.0  ± 22.4  
Day 7 General Health State     59.6  ± 25.9     63.7  ± 23.1  
Day 14 General Health State     66.6  ± 20.9     60.4  ± 23.3  
Day 21 General Health State     66.7  ± 22.2     58.4  ± 23.1  
Day 28 General Health State     69.0  ± 22.9     63.4  ± 22.6  
Day 0 Vitality     49.4  ± 25.3     47.6  ± 17.3  
Day 3 Vitality     56.4  ± 24.3     54.3  ± 20.0  
Day 7 Vitality     60.9  ± 23.1     57.1  ± 22.3  
Day 14 Vitality     69.3  ± 19.4     52.8  ± 24.1  
Day 21 Vitality     68.2  ± 20.4     56.3  ± 25.5  
Day 28 Vitality     69.6  ± 23.2     58.8  ± 24.0  
Day 0 Social Aspects     62.5  ± 34.6     65.9  ± 32.3  
Day 3 Social Aspects     76.9  ± 27.7     75.6  ± 29.7  
Day 7 Social Aspects     80.3  ± 27.9     80.9  ± 29.6  
Day 14 Social Aspects     89.4  ± 17.8     76.6  ± 31.9  
Day 21 Social Aspects     90.9  ± 17.0     79.4  ± 28.9  
Day 28 Social Aspects     89.7  ± 17.4     82.5  ± 25.9  
Day 0 Emotional Aspects     57.5  ± 41.3     62.5  ± 40.1  
Day 3 Emotional Aspects     73.3  ± 37.1     71.7  ± 40.3  
Day 7 Emotional Aspects     80.0  ± 33.6     78.3  ± 38.2  
Day 14 Emotional Aspects     84.2  ± 32.0     80.0  ± 30.9  
Day 21 Emotional Aspects     87.5  ± 24.7     73.3  ± 37.1  
Day 28 Emotional Aspects     81.7  ± 30.1     76.7  ± 36.4  
Day 0 Mental Health     54.3  ± 22.0     58.5  ± 19.7  
Day 3 Mental Health     63.1  ± 22.8     62.9  ± 21.3  
Day 7 Mental Health     67.4  ± 19.2     66.3  ± 21.0  
Day 14 Mental Health     68.5  ± 19.5     65.1  ± 21.3  
Day 21 Mental Health     69.3  ± 20.6     63.7  ± 25.2  
Day 28 Mental Health     66.4  ± 22.5     65.2  ± 22.8  

No statistical analysis provided for Quality of Life Assessed on the SF-36



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

Measure Type Secondary
Measure Title Likert Improvement Assessment Scale
Measure Description 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.
Time Frame Days 0, 3, 7, 14 and 21  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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).

Measured Values
    Acupuncture     Placebo Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Likert Improvement Assessment Scale  
[units: scores on a scale]
Mean ± Standard Deviation 		   
Likert 0 P     1.6  ± 0.54     2.15  ± 0.66  
Likert 0 A     1.6  ± 0.63     2.0  ± 0.78  
Likert 3 P     1.67  ± 0.72     2.27  ± 0.71  
Likert 3 A     1.62  ± 0.66     2.17  ± 0.81  
Likert 7 P     1.67  ± 0.72     2.20  ± 0.79  
Likert 7 A     1.55  ± 0.67     2.07  ± 0.91  
Likert 14 P     1.77  ± 0.73     2.05  ± 0.71  
Likert 14 A     1.65  ± 0.73     2.12  ± 0.82  
Likert 21 P     1.65  ± 0.8     2.07  ± 0.88  
Likert 21 A     1.62  ± 0.8     1.95  ± 0.81  

No statistical analysis provided for Likert Improvement Assessment Scale



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

Measure Type Secondary
Measure Title Number of Anti-inflammatory Tablets Taken
Measure Description Number of 50 mg sodium diclofenac pills taken per day
Time Frame Days 3,7,14,21 and 28  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat (ITT)

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).

Measured Values
    Acupuncture     Placebo Group  
Number of Participants Analyzed  
[units: participants]
 		  40     40  
Number of Anti-inflammatory Tablets Taken  
[units: number of pills/day]
Mean ± Standard Deviation 		   
Day 3     1.5  ± 2.6     2.6  ± 2.8  
Day 7     1.9  ± 3.6     4.2  ± 4.7  
Day 14     1.3  ± 3.1     3.3  ± 6.0  
Day 21     1.2  ± 2.8     3.7  ± 5.2  
Day 28     1.1  ± 2.7     2.3  ± 3.9  

No statistical analysis provided for Number of Anti-inflammatory Tablets Taken




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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