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

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Acupuncture; Device: Electroacupuncture (device 585)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao paulo, SP, Brazil, 01246903
      • Recruiting
      • Medicine School of the University Of São Paulo
      • Contact: Josielli Comachio; Phone Number: +5511987246899; Email: josiellicomachio@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire	6 weeks
Functional Disability	Roland Morris Disability Questionnaire	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Short-Form Health Survey Questionnaire	6 weeks
Global Perceived Effect	Global Perceived Effect Scale	6 weeks
Scale of Kinesiophobia (TSK)	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.	6 weeks
Beck Depression	Beck Depression Inventory BDI	6 weeks
Third finger to the ground	Third finger of the hand to the ground test to assess the flexibility of the posterior chain.	6 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Josielli Comachio, University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimate): January 17, 2014

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: josicomachio