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

Low Back Pain Clinical Trial

— ANLBP  

Official title:

Acupuncture for Acute Nonspecific Low Back Pain: a Randomized, Controlled, Double-blind, Placebo Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124955
• Other study ID #: FDAAAAU
• Status: Completed
• Phase: N/A
• First received: May 13, 2010
• Last updated: June 13, 2011
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Acupuncture
The intervention group (IG) are submitted to five acupuncture sessions using Yamamoto New Scalp Acupuncture(YNSA)
• Non-penetrating acupuncture
The placebo group (PG) are submitted to five non-penetrating acupuncture sessions using YNSA.

Locations

Country	Name	City	State
Brazil	Tatiana Hasegawa	Sao Paulo	SP
Brazil	Tatiana Hasegawa	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	days 0, 3, 7, 14, 21 and 28	Yes
Secondary	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).	days 0, 3, 7, 14, 21 and 28	Yes
Secondary	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.	Days 0, 3, 7, 14, 21 and 28	Yes
Secondary	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.	Days 0, 3, 7, 14 and 21	Yes
Secondary	Number of Anti-inflammatory Tablets Taken	Number of 50 mg sodium diclofenac pills taken per day	Days 3,7,14,21 and 28	Yes