Efficacy of Acupuncture and Electroacupuncture in Patients With Chronic Nonspecific Low Back Pain: Randomized Clinical Trial

NCT ID: NCT02039037

Last Updated: 2015-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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OBJECTIVE: To compare the effect of acupuncture and electroacupuncture as an alternative therapy in patients with chronic low back pain to be able to identify whether electroacupuncture has more benefits than just acupuncture in the treatment of low back pain to be more widespread with scientific.

METHOD: Sixty subjects will be randomized into two groups: Group Acupuncture treatment of low back pain (AG) and Group Acupuncture with the use of electroacupuncture (EG). The primary clinical outcomes will be pain, assessed with the numerical pain scale and McGill Pain Questionnaire and disability assessed with Roland Morris Disability Questionnaire. Secondary outcomes will be measured with global perception scale of global perceived effect, quality of life using the Short-Form Health Survey questionnaire (SF-36), Beck Depression (Beck Depression Inventory BDI), Flexibility, kinesiophobia and through bank Wells. The groups will be treated with two weekly sessions lasting about an hour, 6 weeks, totaling 12 sessions. The outcomes will be achieved in the final and initial ratings after six months of treatment completion. Data will be collected by a blinded examiner who also has made the allocation of patients to groups.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupuncture group

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

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type DEVICE

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

Electroacupuncture group

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

Group Type ACTIVE_COMPARATOR

Electroacupuncture (device 585)

Intervention Type 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.

Interventions

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Acupuncture

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

Intervention Type DEVICE

Electroacupuncture (device 585)

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with severe spinal
* Previous surgeries or scheduled
* Herniated Disc
* Rheumatic disease or infection
* pregnancy
* metal implants
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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JOSIELLI COMACHIO

Efficacy of Acupuncture and Electroacupuncture in patients with chronic nonspecific low back pain: randomized clinical trial

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Josielli Comachio

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Medicine School of the University Of São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Amélia P Marques, PHD

Role: CONTACT

Josielli Comachio

Role: CONTACT

Facility Contacts

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Josielli Comachio

Role: primary

+5511987246899

References

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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.

Reference Type DERIVED
PMID: 26472590 (View on PubMed)

Other Identifiers

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josicomachio

Identifier Type: -

Identifier Source: org_study_id

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