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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by JOSIELLI COMACHIO, University of Sao Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02039037
First Posted: January 17, 2014
Last Update Posted: April 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JOSIELLI COMACHIO, University of Sao Paulo
  Purpose
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.

Condition Intervention
Low Back Pain Device: Acupuncture Device: Electroacupuncture (device 585)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture and Electroacupuncture in Patients With Chronic Nonspecific Low Back Pain: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by JOSIELLI COMACHIO, University of Sao Paulo:

Primary Outcome Measures:
  • Pain [ Time Frame: 6 weeks ]
    Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire

  • Functional Disability [ Time Frame: 6 weeks ]
    Roland Morris Disability Questionnaire


Secondary Outcome Measures:
  • Scale of Kinesiophobia (TSK) [ Time Frame: 6 weeks ]
    Self-applied questionnaire of 17 items, which was developed to measure the fear of movement due to cLBP. Each question has 4 4 response options (strongly disagree, agree, and strongly agree) with scores respectively ranging from 1 to 4 points.

  • Quality of life [ Time Frame: 6 weeks ]
    Short-Form Health Survey Questionnaire

  • Global Perceived Effect [ Time Frame: 6 weeks ]
    Global Perceived Effect Scale

  • Beck Depression [ Time Frame: 6 weeks ]
    Beck Depression Inventory BDI

  • Third finger to the ground [ Time Frame: 6 weeks ]
    Third finger of the hand to the ground test to assess the flexibility of the posterior chain.


Estimated Enrollment: 66
Study Start Date: January 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acupuncture group
This group perform acupuncture needles brand Dong Bang 20x15 in specific spots for the treatment of low back pain.
Device: Acupuncture
Acupuncture Group, which will hold acupuncture needles brand Dong Bang 20x15 in specific spots for the treatment of low back pain.
Active Comparator: 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.
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.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039037


Contacts
Contact: Amélia P Marques, PHD pasqual@usp.br
Contact: Josielli Comachio josiellicomachio@usp.br

Locations
Brazil
Medicine School of the University Of São Paulo Recruiting
Sao paulo, SP, Brazil, 01246903
Contact: Josielli Comachio    +5511987246899    josiellicomachio@usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Josielli Comachio University of Sao Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JOSIELLI COMACHIO, Efficacy of Acupuncture and Electroacupuncture in patients with chronic nonspecific low back pain: randomized clinical trial, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02039037     History of Changes
Other Study ID Numbers: josicomachio
First Submitted: October 30, 2013
First Posted: January 17, 2014
Last Update Posted: April 3, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms