Trial Outcomes & Findings for Acupuncture Using Yamamoto's Method for the Treatment of Acute Nonspecific Low Back Pain (NCT NCT01124955)
NCT ID: NCT01124955
Last Updated: 2011-06-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
days 0, 3, 7, 14, 21 and 28
Results posted on
2011-06-15
Participant Flow
100 patients were recruited from the university hospital of the Federal University of São Paul (UNIFESP), from November 2009 to June 2010.
80 patients were randomized during the study.
Participant milestones
| Measure |
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).
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture Using Yamamoto's Method for the Treatment of Acute Nonspecific Low Back Pain
Baseline characteristics by cohort
| Measure |
Acupuncture
n=40 Participants
The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
|
Placebo Group
n=40 Participants
Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age Continuous
|
47 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: days 0, 3, 7, 14, 21 and 28Population: Intention to treat analysis (ITT)
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.
Outcome measures
| Measure |
Acupuncture
n=40 cm
The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
|
Placebo Group
n=40 cm
Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
|
|---|---|---|
|
Pain Assessed on a 10-point Numeric Pain Scale
Day 0
|
6.55 cm
Standard Deviation 1.4
|
6.68 cm
Standard Deviation 1.44
|
|
Pain Assessed on a 10-point Numeric Pain Scale
Day 3
|
4.63 cm
Standard Deviation 2.23
|
5.13 cm
Standard Deviation 2.21
|
|
Pain Assessed on a 10-point Numeric Pain Scale
Day 7
|
3.83 cm
Standard Deviation 2.61
|
4.4 cm
Standard Deviation 2.09
|
|
Pain Assessed on a 10-point Numeric Pain Scale
Day 14
|
2.8 cm
Standard Deviation 2.27
|
3.95 cm
Standard Deviation 2.19
|
|
Pain Assessed on a 10-point Numeric Pain Scale
Day 21
|
2.49 cm
Standard Deviation 2.4
|
4.18 cm
Standard Deviation 2.52
|
|
Pain Assessed on a 10-point Numeric Pain Scale
Day 28
|
1.98 cm
Standard Deviation 2.12
|
3.38 cm
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: days 0, 3, 7, 14, 21 and 28Population: Intention to treat analysis (ITT)
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).
Outcome measures
| Measure |
Acupuncture
n=40 scores on a scale
The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
|
Placebo Group
n=40 scores on a scale
Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
|
|---|---|---|
|
Roland-Morris Disability Questionnaire (RM)
Day 0
|
14.9 scores on a scale
Standard Deviation 4.0
|
14.6 scores on a scale
Standard Deviation 4.8
|
|
Roland-Morris Disability Questionnaire (RM)
Day 3
|
10.3 scores on a scale
Standard Deviation 5.4
|
12.4 scores on a scale
Standard Deviation 4.5
|
|
Roland-Morris Disability Questionnaire (RM)
Day 7
|
8.1 scores on a scale
Standard Deviation 5.5
|
10.2 scores on a scale
Standard Deviation 5.3
|
|
Roland-Morris Disability Questionnaire (RM)
Day14
|
5.3 scores on a scale
Standard Deviation 4.6
|
8.9 scores on a scale
Standard Deviation 5.2
|
|
Roland-Morris Disability Questionnaire (RM)
Day 21
|
4.40 scores on a scale
Standard Deviation 4.4
|
8.5 scores on a scale
Standard Deviation 6.2
|
|
Roland-Morris Disability Questionnaire (RM)
Day 28
|
4.1 scores on a scale
Standard Deviation 4.7
|
8.0 scores on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Days 0, 3, 7, 14, 21 and 28Population: Intention to treat analysis (ITT)
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.
Outcome measures
| Measure |
Acupuncture
n=40 scale
The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
|
Placebo Group
n=40 scale
Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
|
|---|---|---|
|
Quality of Life Assessed on the SF-36
Day 0 Functional Capacity
|
46.4 scores on a scale
Standard Deviation 22.7
|
55.8 scores on a scale
Standard Deviation 19.2
|
|
Quality of Life Assessed on the SF-36
Day 3 Functional Capacity
|
58.5 scores on a scale
Standard Deviation 25.7
|
60.6 scores on a scale
Standard Deviation 19.6
|
|
Quality of Life Assessed on the SF-36
Day 7 Functional Capacity
|
68.8 scores on a scale
Standard Deviation 22.3
|
66.6 scores on a scale
Standard Deviation 17.1
|
|
Quality of Life Assessed on the SF-36
Day 14 Functional Capacity
|
78.6 scores on a scale
Standard Deviation 20.8
|
71.6 scores on a scale
Standard Deviation 20.8
|
|
Quality of Life Assessed on the SF-36
Day 21 Functional Capacity
|
81.8 scores on a scale
Standard Deviation 17.6
|
71.4 scores on a scale
Standard Deviation 21.7
|
|
Quality of Life Assessed on the SF-36
Day 28 Functional Capacity
|
84.0 scores on a scale
Standard Deviation 19.8
|
70.9 scores on a scale
Standard Deviation 22.5
|
|
Quality of Life Assessed on the SF-36
Day 0 limitation in physical aspects
|
18.1 scores on a scale
Standard Deviation 26.5
|
16.3 scores on a scale
Standard Deviation 26.3
|
|
Quality of Life Assessed on the SF-36
Day 3 limitation in physical aspects
|
35.6 scores on a scale
Standard Deviation 37.9
|
30.6 scores on a scale
Standard Deviation 33.2
|
|
Quality of Life Assessed on the SF-36
Day 7 limitation in physical aspects
|
53.1 scores on a scale
Standard Deviation 39.7
|
43.8 scores on a scale
Standard Deviation 40.7
|
|
Quality of Life Assessed on the SF-36
Day 14 limitation in physical aspects
|
70.6 scores on a scale
Standard Deviation 36.2
|
55.0 scores on a scale
Standard Deviation 35.0
|
|
Quality of Life Assessed on the SF-36
Day 21 limitation in physical aspects
|
75.6 scores on a scale
Standard Deviation 33.7
|
56.3 scores on a scale
Standard Deviation 39.9
|
|
Quality of Life Assessed on the SF-36
Day 28 limitation in physical aspects
|
78.8 scores on a scale
Standard Deviation 31.8
|
55.8 scores on a scale
Standard Deviation 38.3
|
|
Quality of Life Assessed on the SF-36
Day 0 Pain
|
27.6 scores on a scale
Standard Deviation 17.9
|
28.8 scores on a scale
Standard Deviation 19.1
|
|
Quality of Life Assessed on the SF-36
Day 3 Pain
|
46.1 scores on a scale
Standard Deviation 24.9
|
44.8 scores on a scale
Standard Deviation 19.4
|
|
Quality of Life Assessed on the SF-36
Day 7 Pain
|
54.8 scores on a scale
Standard Deviation 20.0
|
51.5 scores on a scale
Standard Deviation 21.4
|
|
Quality of Life Assessed on the SF-36
Day 14 Pain
|
64.9 scores on a scale
Standard Deviation 20.3
|
53.6 scores on a scale
Standard Deviation 19.2
|
|
Quality of Life Assessed on the SF-36
Day 21 Pain
|
69.3 scores on a scale
Standard Deviation 22.7
|
54.6 scores on a scale
Standard Deviation 24.7
|
|
Quality of Life Assessed on the SF-36
Day 28 Pain
|
67.8 scores on a scale
Standard Deviation 26.1
|
56.5 scores on a scale
Standard Deviation 23.4
|
|
Quality of Life Assessed on the SF-36
Day 0 General Health State
|
54.2 scores on a scale
Standard Deviation 25.7
|
56.5 scores on a scale
Standard Deviation 24.9
|
|
Quality of Life Assessed on the SF-36
Day 3 General Health State
|
60.5 scores on a scale
Standard Deviation 23.0
|
62.0 scores on a scale
Standard Deviation 22.4
|
|
Quality of Life Assessed on the SF-36
Day 7 General Health State
|
59.6 scores on a scale
Standard Deviation 25.9
|
63.7 scores on a scale
Standard Deviation 23.1
|
|
Quality of Life Assessed on the SF-36
Day 14 General Health State
|
66.6 scores on a scale
Standard Deviation 20.9
|
60.4 scores on a scale
Standard Deviation 23.3
|
|
Quality of Life Assessed on the SF-36
Day 21 General Health State
|
66.7 scores on a scale
Standard Deviation 22.2
|
58.4 scores on a scale
Standard Deviation 23.1
|
|
Quality of Life Assessed on the SF-36
Day 28 General Health State
|
69.0 scores on a scale
Standard Deviation 22.9
|
63.4 scores on a scale
Standard Deviation 22.6
|
|
Quality of Life Assessed on the SF-36
Day 0 Vitality
|
49.4 scores on a scale
Standard Deviation 25.3
|
47.6 scores on a scale
Standard Deviation 17.3
|
|
Quality of Life Assessed on the SF-36
Day 3 Vitality
|
56.4 scores on a scale
Standard Deviation 24.3
|
54.3 scores on a scale
Standard Deviation 20.0
|
|
Quality of Life Assessed on the SF-36
Day 7 Vitality
|
60.9 scores on a scale
Standard Deviation 23.1
|
57.1 scores on a scale
Standard Deviation 22.3
|
|
Quality of Life Assessed on the SF-36
Day 14 Vitality
|
69.3 scores on a scale
Standard Deviation 19.4
|
52.8 scores on a scale
Standard Deviation 24.1
|
|
Quality of Life Assessed on the SF-36
Day 21 Vitality
|
68.2 scores on a scale
Standard Deviation 20.4
|
56.3 scores on a scale
Standard Deviation 25.5
|
|
Quality of Life Assessed on the SF-36
Day 28 Vitality
|
69.6 scores on a scale
Standard Deviation 23.2
|
58.8 scores on a scale
Standard Deviation 24.0
|
|
Quality of Life Assessed on the SF-36
Day 0 Social Aspects
|
62.5 scores on a scale
Standard Deviation 34.6
|
65.9 scores on a scale
Standard Deviation 32.3
|
|
Quality of Life Assessed on the SF-36
Day 3 Social Aspects
|
76.9 scores on a scale
Standard Deviation 27.7
|
75.6 scores on a scale
Standard Deviation 29.7
|
|
Quality of Life Assessed on the SF-36
Day 7 Social Aspects
|
80.3 scores on a scale
Standard Deviation 27.9
|
80.9 scores on a scale
Standard Deviation 29.6
|
|
Quality of Life Assessed on the SF-36
Day 14 Social Aspects
|
89.4 scores on a scale
Standard Deviation 17.8
|
76.6 scores on a scale
Standard Deviation 31.9
|
|
Quality of Life Assessed on the SF-36
Day 21 Social Aspects
|
90.9 scores on a scale
Standard Deviation 17.0
|
79.4 scores on a scale
Standard Deviation 28.9
|
|
Quality of Life Assessed on the SF-36
Day 28 Social Aspects
|
89.7 scores on a scale
Standard Deviation 17.4
|
82.5 scores on a scale
Standard Deviation 25.9
|
|
Quality of Life Assessed on the SF-36
Day 0 Emotional Aspects
|
57.5 scores on a scale
Standard Deviation 41.3
|
62.5 scores on a scale
Standard Deviation 40.1
|
|
Quality of Life Assessed on the SF-36
Day 3 Emotional Aspects
|
73.3 scores on a scale
Standard Deviation 37.1
|
71.7 scores on a scale
Standard Deviation 40.3
|
|
Quality of Life Assessed on the SF-36
Day 7 Emotional Aspects
|
80.0 scores on a scale
Standard Deviation 33.6
|
78.3 scores on a scale
Standard Deviation 38.2
|
|
Quality of Life Assessed on the SF-36
Day 14 Emotional Aspects
|
84.2 scores on a scale
Standard Deviation 32.0
|
80.0 scores on a scale
Standard Deviation 30.9
|
|
Quality of Life Assessed on the SF-36
Day 21 Emotional Aspects
|
87.5 scores on a scale
Standard Deviation 24.7
|
73.3 scores on a scale
Standard Deviation 37.1
|
|
Quality of Life Assessed on the SF-36
Day 28 Emotional Aspects
|
81.7 scores on a scale
Standard Deviation 30.1
|
76.7 scores on a scale
Standard Deviation 36.4
|
|
Quality of Life Assessed on the SF-36
Day 0 Mental Health
|
54.3 scores on a scale
Standard Deviation 22.0
|
58.5 scores on a scale
Standard Deviation 19.7
|
|
Quality of Life Assessed on the SF-36
Day 3 Mental Health
|
63.1 scores on a scale
Standard Deviation 22.8
|
62.9 scores on a scale
Standard Deviation 21.3
|
|
Quality of Life Assessed on the SF-36
Day 7 Mental Health
|
67.4 scores on a scale
Standard Deviation 19.2
|
66.3 scores on a scale
Standard Deviation 21.0
|
|
Quality of Life Assessed on the SF-36
Day 14 Mental Health
|
68.5 scores on a scale
Standard Deviation 19.5
|
65.1 scores on a scale
Standard Deviation 21.3
|
|
Quality of Life Assessed on the SF-36
Day 21 Mental Health
|
69.3 scores on a scale
Standard Deviation 20.6
|
63.7 scores on a scale
Standard Deviation 25.2
|
|
Quality of Life Assessed on the SF-36
Day 28 Mental Health
|
66.4 scores on a scale
Standard Deviation 22.5
|
65.2 scores on a scale
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: Days 0, 3, 7, 14 and 21Likert 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.
Outcome measures
| Measure |
Acupuncture
n=40 Participants
The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
|
Placebo Group
n=40 Participants
Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
|
|---|---|---|
|
Likert Improvement Assessment Scale
Likert 0 P
|
1.6 scores on a scale
Standard Deviation 0.54
|
2.15 scores on a scale
Standard Deviation 0.66
|
|
Likert Improvement Assessment Scale
Likert 0 A
|
1.6 scores on a scale
Standard Deviation 0.63
|
2.0 scores on a scale
Standard Deviation 0.78
|
|
Likert Improvement Assessment Scale
Likert 3 P
|
1.67 scores on a scale
Standard Deviation 0.72
|
2.27 scores on a scale
Standard Deviation 0.71
|
|
Likert Improvement Assessment Scale
Likert 3 A
|
1.62 scores on a scale
Standard Deviation 0.66
|
2.17 scores on a scale
Standard Deviation 0.81
|
|
Likert Improvement Assessment Scale
Likert 7 P
|
1.67 scores on a scale
Standard Deviation 0.72
|
2.20 scores on a scale
Standard Deviation 0.79
|
|
Likert Improvement Assessment Scale
Likert 7 A
|
1.55 scores on a scale
Standard Deviation 0.67
|
2.07 scores on a scale
Standard Deviation 0.91
|
|
Likert Improvement Assessment Scale
Likert 14 P
|
1.77 scores on a scale
Standard Deviation 0.73
|
2.05 scores on a scale
Standard Deviation 0.71
|
|
Likert Improvement Assessment Scale
Likert 14 A
|
1.65 scores on a scale
Standard Deviation 0.73
|
2.12 scores on a scale
Standard Deviation 0.82
|
|
Likert Improvement Assessment Scale
Likert 21 P
|
1.65 scores on a scale
Standard Deviation 0.8
|
2.07 scores on a scale
Standard Deviation 0.88
|
|
Likert Improvement Assessment Scale
Likert 21 A
|
1.62 scores on a scale
Standard Deviation 0.8
|
1.95 scores on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Days 3,7,14,21 and 28Population: Intention to treat (ITT)
Number of 50 mg sodium diclofenac pills taken per day
Outcome measures
| Measure |
Acupuncture
n=40 Participants
The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
|
Placebo Group
n=40 Participants
Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
|
|---|---|---|
|
Number of Anti-inflammatory Tablets Taken
Day 3
|
1.5 number of pills/day
Standard Deviation 2.6
|
2.6 number of pills/day
Standard Deviation 2.8
|
|
Number of Anti-inflammatory Tablets Taken
Day 7
|
1.9 number of pills/day
Standard Deviation 3.6
|
4.2 number of pills/day
Standard Deviation 4.7
|
|
Number of Anti-inflammatory Tablets Taken
Day 14
|
1.3 number of pills/day
Standard Deviation 3.1
|
3.3 number of pills/day
Standard Deviation 6.0
|
|
Number of Anti-inflammatory Tablets Taken
Day 21
|
1.2 number of pills/day
Standard Deviation 2.8
|
3.7 number of pills/day
Standard Deviation 5.2
|
|
Number of Anti-inflammatory Tablets Taken
Day 28
|
1.1 number of pills/day
Standard Deviation 2.7
|
2.3 number of pills/day
Standard Deviation 3.9
|
Adverse Events
Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tatiana Molinas Hasegawa
Federal University of São Paulo
Phone: 55 115576 4239
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place