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

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ClinicalTrials.gov Identifier: NCT01124955
Recruitment Status : Completed
First Posted : May 18, 2010
Results First Posted : June 13, 2011
Last Update Posted : June 15, 2011
Sponsor:
Information provided by:
Federal University of São Paulo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Low Back Pain
Interventions Other: Acupuncture
Other: Non-penetrating acupuncture
Enrollment 80
Recruitment Details 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 80 patients were randomized during the study.
Arm/Group Title Acupuncture Placebo Group
Hide Arm/Group Description The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA. Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
Period Title: Overall Study
Started 40 40
Completed 40 40
Not Completed 0 0
Arm/Group Title Acupuncture Placebo Group Total
Hide Arm/Group Description The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA. Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG). Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Between 18 and 65 years
40
 100.0%
40
 100.0%
80
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
47  (9.8) 43.9  (10.9) 45.4  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
25
  62.5%
26
  65.0%
51
  63.7%
Male
15
  37.5%
14
  35.0%
29
  36.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Pain Assessed on a 10-point Numeric Pain Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis (ITT)
Arm/Group Title Acupuncture Placebo Group
Hide Arm/Group Description:
The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
Overall Number of Participants Analyzed 40 40
Overall Number of Units Analyzed
Type of Units Analyzed: Cm
40 40
Mean (Standard Deviation)
Unit of Measure: cm
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)
2.Secondary Outcome
Title Roland-Morris Disability Questionnaire (RM)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis (ITT)
Arm/Group Title Acupuncture Placebo Group
Hide Arm/Group Description:
The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
Overall Number of Participants Analyzed 40 40
Overall Number of Units Analyzed
Type of Units Analyzed: Scores on a scale
40 40
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acupuncture, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0,05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Quality of Life Assessed on the SF-36
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis (ITT)
Arm/Group Title Acupuncture Placebo Group
Hide Arm/Group Description:
The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
Overall Number of Participants Analyzed 40 40
Overall Number of Units Analyzed
Type of Units Analyzed: Scale
40 40
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
4.Secondary Outcome
Title Likert Improvement Assessment Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acupuncture Placebo Group
Hide Arm/Group Description:
The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: scores on a scale
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)
5.Secondary Outcome
Title Number of Anti-inflammatory Tablets Taken
Hide Description Number of 50 mg sodium diclofenac pills taken per day
Time Frame Days 3,7,14,21 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Acupuncture Placebo Group
Hide Arm/Group Description:
The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: number of pills/day
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)
Time Frame Non-serious adverse events were collected during de follow-up (28 days).
Adverse Event Reporting Description 80 patients were evaluated in the end of the study and non-serious adverse events were observed.
 
Arm/Group Title Acupuncture Placebo Group
Hide Arm/Group Description The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA. Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
All-Cause Mortality
Acupuncture Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acupuncture Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0,001%
Acupuncture Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tatiana Molinas Hasegawa
Organization: Federal University of São Paulo
Phone: 55 115576 4239
EMail: tatianamolinas@hotmail.com
Layout table for additonal information
Responsible Party: Tatiana Molinas Hasegawa, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01124955     History of Changes
Other Study ID Numbers: FDAAAAU
First Submitted: May 13, 2010
First Posted: May 18, 2010
Results First Submitted: August 9, 2010
Results First Posted: June 13, 2011
Last Update Posted: June 15, 2011