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

Not Applicable

• Conditions: Low Back Pain
• Interventions: Device: Electroacupuncture (device 585); Device: Acupuncture

• Registration Number: NCT02039037
• Lead Sponsor: University of Sao Paulo General Hospital

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.

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 Timeline

• Study First Submitted: 2013-10-30
• Study Start: 2014-01
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-17
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-03
• Primary Completion: 2015-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture group	Electroacupuncture (device 585)	Electro Group, will be added through the use of electrical stimulation of electroacupuncture using the apparatus Accurate pulse 585 at the same points.
Acupuncture group	Acupuncture	This group perform acupuncture needles brand Dong Bang 20x15 in specific spots for the treatment of low back pain.

Primary Outcome Measures

Name	Time	Method
Pain	6 weeks	Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire
Functional Disability	6 weeks	Roland Morris Disability Questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medicine School of the University Of São Paulo; 🇧🇷 Sao paulo, SP, Brazil