Acupuncture Using Yamamoto's Method for the Treatment of Acute Nonspecific Low Back Pain (ANLBP)
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Acupuncture
Non-penetrating acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring treatment, acupuncture, spine
Eligibility Criteria
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
Sites / Locations
- Tatiana Hasegawa
- Tatiana Hasegawa
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention Group
Non-penetrating acupuncture
Arm Description
Patients receive 5 sessions of real acupuncture. The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
The placebo group (PG) are submitted to five non-penetrating acupuncture sessions using YNSA.
Outcomes
Primary Outcome Measures
Pain Assessed on a 10-point Numeric Pain Scale
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
Roland-Morris Disability Questionnaire (RM)
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).
Quality of Life Assessed on the SF-36
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.
Likert Improvement Assessment Scale
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.
Number of Anti-inflammatory Tablets Taken
Number of 50 mg sodium diclofenac pills taken per day
Full Information
NCT ID
NCT01124955
First Posted
May 13, 2010
Last Updated
June 13, 2011
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01124955
Brief Title
Acupuncture Using Yamamoto's Method for the Treatment of Acute Nonspecific Low Back Pain
Acronym
ANLBP
Official Title
Acupuncture for Acute Nonspecific Low Back Pain: a Randomized, Controlled, Double-blind, Placebo Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
treatment, acupuncture, spine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Patients receive 5 sessions of real acupuncture. The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
Arm Title
Non-penetrating acupuncture
Arm Type
Placebo Comparator
Arm Description
The placebo group (PG) are submitted to five non-penetrating acupuncture sessions using YNSA.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Other Intervention Name(s)
Real acupuncture
Intervention Description
The intervention group (IG) are submitted to five acupuncture sessions using Yamamoto New Scalp Acupuncture(YNSA)
Intervention Type
Other
Intervention Name(s)
Non-penetrating acupuncture
Other Intervention Name(s)
Placebo acupuncture
Intervention Description
The placebo group (PG) are submitted to five non-penetrating acupuncture sessions using YNSA.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamil Natour, MD,PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Tatiana Hasegawa
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04011060
Country
Brazil
Facility Name
Tatiana Hasegawa
City
São Paulo
ZIP/Postal Code
04011-060
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19942724
Citation
Inoue M, Hojo T, Nakajima M, Kitakoji H, Itoi M. Comparison of the effectiveness of acupuncture treatment and local anaesthetic injection for low back pain: a randomised controlled clinical trial. Acupunct Med. 2009 Dec;27(4):174-7. doi: 10.1136/aim.2009.001164.
Results Reference
background
PubMed Identifier
24316509
Citation
Hasegawa TM, Baptista AS, de Souza MC, Yoshizumi AM, Natour J. Acupuncture for acute non-specific low back pain: a randomised, controlled, double-blind, placebo trial. Acupunct Med. 2014 Apr;32(2):109-15. doi: 10.1136/acupmed-2013-010333. Epub 2013 Dec 6.
Results Reference
derived
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Acupuncture Using Yamamoto's Method for the Treatment of Acute Nonspecific Low Back Pain
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