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

Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01124955
Collaborator
(none)
80
Enrollment
2
Locations
2
Arms
13
Duration (Months)
40
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: Acupuncture
  • Other: Non-penetrating acupuncture
 N/A

Detailed Description

A randomized, controlled, double-blind, prospective trial is being conducted involving 80 patients with low-back pain defined as pain and discomfort localised bellow the costal margin and above the inferior gluteal folds, for a period of less than 30 days and unrelated to any specific etiological factors. Patients are being recruited from the university hospital of the Federal University of Sao Paul (UNIFESP)and exams were carried out by a rheumatologist. The patients are randomly assigned to either intervention group (IG) and are submitted to five acupuncture sessions or placebo group (PG) and are submitted to five non-penetrating acupuncture sessions. Both groups are recommended to take 50 mg of sodium diclofenac every eight hours for lumbar pain, if needed and record the number of pills on a standardized form.

The patients are instructed not to use other medications or therapies for low-back pain during the study.The IG are submitted to acupuncture by a physician acupuncturist with eight years experience in the technique. Five acupuncture session are performed at baseline, D3, D7, D14 and D21. Specific needles for scalp acupuncture and tubes that guide these needles, called mandrels are unpacked in front of the patient. The stainless steel needles: 0.20 x 13 mm, sterilized and disposable.Sessions last 20 minutes. The patient remain seated, using a hat with a central orifice exposing the area to receive the needles. The hat has a wide brim to keep the patient blinded for the procedures. The needle penetrates the skin at an approximately 15º angle and a depth of 0.3 to 0.5 cm. The PG are submitted to five placebo acupuncture session performed by the same acupuncturist with same material and hat, but penetration did not occur and only the mandrel came into contact with the skin. All patients are blind to which procedure they are receiving. The basic points D, H and I and kidney, bladder and liver points of Yamamoto's method are used as standard treatment to ANLBP for the both groups.

Evaluations: The IG and PG are evaluated six times between baseline and Day 28 immediately before and after each acupuncture session. Outcome measures are recorded by a single assessor blinded to group allocation.

D0: baseline; D3: three days after baseline; D7: seven days after baseline; D14: fourteen days after baseline; D21: twenty-one days after baseline and D28: twenty-eight days after baseline.

Losses: Participants absent from more than three acupuncture sessions and evaluations are considered losses.

Placebo credibility: At the end of the study, participants are asked about which group they believed they belonged.

Sample size: To achieve an improvement in VAS pain of 2.0 point, with a significance of 0.05, and a power of 0.90, a minimum of 40 patients per group is necessary as a previous compensation for the possible 20% loss at follow-up.

Statistics: An intention-to-treat analysis are performed, using the last-observation-carried-forward method. A level of significance of p < 0.05 (2-tailed tests) are accepted for the trial. For normally distributed data, the variables are analysed using repeated-measures analysis of variance (ANOVA). The analysis are performed between groups (acupuncture versus non-penetrating acupuncture; between subjects factors) and over the time (baseline, 3, 7, 14, 21 and 28 days; within subjects factors). Categorical data measured over time are analysed using repeated-measures analyses of variance (ANOVA) for categorical data. A 95% confidence interval (95% CI) are used. The Student's t-test are used to compare numerical variables with normal distribution at one time and the chi-square test or Fisher's exact test are used to determine differences in rates of improvement between the two groups. The Kappa index are used to determine agreement on the LIKERT assessment between patient and assessor. All tests are performed using SPSS version 15.0 and MINITAB 14.0

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Acupuncture for Acute Nonspecific Low Back Pain: a Randomized, Controlled, Double-blind, Placebo Trial
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Placebo acupuncture

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain Assessed on a 10-point Numeric Pain Scale [days 0, 3, 7, 14, 21 and 28]

      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

    1. Roland-Morris Disability Questionnaire (RM) [days 0, 3, 7, 14, 21 and 28]

      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).

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

      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.

    3. Likert Improvement Assessment Scale [Days 0, 3, 7, 14 and 21]

      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.

    4. Number of Anti-inflammatory Tablets Taken [Days 3,7,14,21 and 28]

      Number of 50 mg sodium diclofenac pills taken per day

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Tatiana Hasegawa Sao Paulo SP Brazil 04011060
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01124955
    Other Study ID Numbers:
    • FDAAAAU
    First Posted:
    May 18, 2010
    Last Update Posted:
    Jun 15, 2011
    Last Verified:
    Nov 1, 2009
    Keywords provided by , ,
    treatment
    acupuncture
    spine
    Additional relevant MeSH terms:
    Back Pain
    Low Back Pain

    Study Results

    Participant Flow

    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 Detail 80 patients were randomized during the study.
    Arm/Group Title Acupuncture Placebo Group
    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

    Baseline Characteristics

    Arm/Group Title Acupuncture Placebo Group Total
    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 Participants 40 40 80
    Age (Count of Participants)
    Between 18 and 65 years
    40
    100%
    40
    100%
    80
    100%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    47
    (9.8)
    43.9
    (10.9)
    45.4
    (10.3)
    Sex: Female, Male (Count of Participants)
    Female
    25
    62.5%
    26
    65%
    51
    63.8%
    Male
    15
    37.5%
    14
    35%
    29
    36.3%
    Region of Enrollment (participants) [Number]
    Brazil
    40
    100%
    40
    100%
    80
    100%

    Outcome Measures

    1. Primary Outcome
    Title Pain Assessed on a 10-point Numeric Pain Scale
    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

    Outcome Measure Data

    Analysis Population Description
    Intention to treat analysis (ITT)
    Arm/Group Title Acupuncture Placebo Group
    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).
    Measure Participants 40 40
    Measure cm 40 40
    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)
    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

    Outcome Measure Data

    Analysis Population Description
    Intention to treat analysis (ITT)
    Arm/Group Title Acupuncture Placebo Group
    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).
    Measure Participants 40 40
    Measure scores on a scale 40 40
    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
    Statistical Analysis Overview Comparison Group Selection Acupuncture, Placebo Group
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0,05
    Comments
    Method ANOVA
    Comments
    3. Secondary Outcome
    Title Quality of Life Assessed on the SF-36
    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

    Outcome Measure Data

    Analysis Population Description
    Intention to treat analysis (ITT)
    Arm/Group Title Acupuncture Placebo Group
    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).
    Measure Participants 40 40
    Measure scale 40 40
    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
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Acupuncture Placebo Group
    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).
    Measure Participants 40 40
    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
    Description Number of 50 mg sodium diclofenac pills taken per day
    Time Frame Days 3,7,14,21 and 28

    Outcome Measure Data

    Analysis Population Description
    Intention to treat (ITT)
    Arm/Group Title Acupuncture Placebo Group
    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).
    Measure Participants 40 40
    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)

    Adverse Events

    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
    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 (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Acupuncture Placebo Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/40 (0%) 0/40 (0%)
    Other (Not Including Serious) Adverse Events
    Acupuncture Placebo Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/40 (0%) 0/40 (0%)

    Limitations/Caveats

    [Not Specified]

    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.

    Results Point of Contact

    Name/Title Tatiana Molinas Hasegawa
    Organization Federal University of São Paulo
    Phone 55 115576 4239
    Email tatianamolinas@hotmail.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01124955
    Other Study ID Numbers:
    • FDAAAAU
    First Posted:
    May 18, 2010
    Last Update Posted:
    Jun 15, 2011
    Last Verified:
    Nov 1, 2009