NCT02039037

Brief Summary

Chronic nonspecific low back pain is a major health and socioeconomic responsible for a high rate of employee absenteeism and reduced functional performance. The use of acupuncture as an alternative therapy in the treatment of low back pain and electroacupuncture to enhance the treatment has been effective; however, there is little evidence of the effectiveness of one over the other.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

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

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 30, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

October 30, 2013

Last Update Submit

April 2, 2015

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • Pain

    Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire

    6 weeks

  • Functional Disability

    Roland Morris Disability Questionnaire

    6 weeks

Secondary Outcomes (5)

  • Scale of Kinesiophobia (TSK)

    6 weeks

  • Quality of life

    6 weeks

  • Global Perceived Effect

    6 weeks

  • Beck Depression

    6 weeks

  • Third finger to the ground

    6 weeks

Study Arms (2)

Acupuncture group

ACTIVE COMPARATOR

This group perform acupuncture needles brand Dong Bang 20x15 in specific spots for the treatment of low back pain.

Device: Acupuncture

Electroacupuncture group

ACTIVE COMPARATOR

Electro Group, will be added through the use of electrical stimulation of electroacupuncture using the apparatus Accurate pulse 585 at the same points.

Device: Electroacupuncture (device 585)

Interventions

AcupunctureDEVICE

Acupuncture Group, which will hold acupuncture needles brand Dong Bang 20x15 in specific spots for the treatment of low back pain.

Acupuncture group
Electroacupuncture (device 585)DEVICE

Electro will be added through the use of electrical stimulation to the Electro Accurate use of the device 585 at the same points Pulse.

Electroacupuncture group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic low back pain (pain for more than three months)
  • Be between 20-60 years

You may not qualify if:

  • Patients with severe spinal
  • Previous surgeries or scheduled
  • Herniated Disc
  • Rheumatic disease or infection
  • pregnancy
  • metal implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine School of the University Of São Paulo

São Paulo, São Paulo, 01246903, Brazil

RECRUITING

Related Publications (1)

  • Comachio J, Oliveira Magalhaes M, Nogueira Burke T, Vidal Ramos LA, Peixoto Leao Almeida G, Silva AP, Ferreira de Meneses SR, Costa-Frutuoso JR, Santos Miotto Amorim C, Pasqual Marques A. Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial. Trials. 2015 Oct 15;16:469. doi: 10.1186/s13063-015-0850-7.

    PMID: 26472590DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupuncture TherapyElectroacupuncture

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsCombined Modality TherapyElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Josielli Comachio

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélia P Marques, PHD

CONTACT

pasqual@usp.br

Josielli Comachio

CONTACT

josiellicomachio@usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Efficacy of Acupuncture and Electroacupuncture in patients with chronic nonspecific low back pain: randomized clinical trial

Study Record Dates

First Submitted

October 30, 2013

First Posted

January 17, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2016

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

BR(1)