NCT01124955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
6 months until next milestone

Results Posted

Study results publicly available

June 13, 2011

Completed
Last Updated

June 15, 2011

Status Verified

November 1, 2009

Enrollment Period

7 months

First QC Date

May 13, 2010

Results QC Date

August 9, 2010

Last Update Submit

June 13, 2011

Conditions

Low Back Pain

Keywords

treatmentacupuncturespine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Roland-Morris Disability Questionnaire (RM)

    days 0, 3, 7, 14, 21 and 28

  • Quality of Life Assessed on the SF-36

    Days 0, 3, 7, 14, 21 and 28

  • Likert Improvement Assessment Scale

    Days 0, 3, 7, 14 and 21

  • Number of Anti-inflammatory Tablets Taken

    Days 3,7,14,21 and 28

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Patients receive 5 sessions of real acupuncture. The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.

Other: Acupuncture

Non-penetrating acupuncture

PLACEBO COMPARATOR

The placebo group (PG) are submitted to five non-penetrating acupuncture sessions using YNSA.

Other: Non-penetrating acupuncture

Interventions

AcupunctureOTHER

The intervention group (IG) are submitted to five acupuncture sessions using Yamamoto New Scalp Acupuncture(YNSA)

Also known as: Real acupuncture
Intervention Group
Non-penetrating acupunctureOTHER

The placebo group (PG) are submitted to five non-penetrating acupuncture sessions using YNSA.

Also known as: Placebo acupuncture
Non-penetrating acupuncture

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tatiana Hasegawa

São Paulo, São Paulo, 04011-060, Brazil

Location

Tatiana Hasegawa

São Paulo, São Paulo, 04011060, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 19942724BACKGROUND

  • 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.

    PMID: 24316509DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Tatiana Molinas Hasegawa
Organization
Federal University of São Paulo
tatianamolinas@hotmail.com
55 115576 4239

Study Officials

  • Jamil Natour, MD,PhD

    Federal University of São Paulo

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2010

First Posted

May 18, 2010

Study Start

November 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

June 15, 2011

Results First Posted

June 13, 2011

Record last verified: 2009-11

Locations

BR(2)