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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02039037
• Other study ID #: josicomachio
• Status: Recruiting
• Phase: N/A
• First received: October 30, 2013
• Last updated: April 2, 2015
• Start date: January 2014
• Est. completion date: September 2016

Study information

• Verified date: April 2015
• Source: University of Sao Paulo General Hospital
• Contact: Amélia P Marques, PHD
• Email: pasqual[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Medicine School of the University Of São Paulo	Sao paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire	6 weeks	Yes
Primary	Functional Disability	Roland Morris Disability Questionnaire	6 weeks	Yes
Secondary	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	Yes
Secondary	Quality of life	Short-Form Health Survey Questionnaire	6 weeks	Yes
Secondary	Global Perceived Effect	Global Perceived Effect Scale	6 weeks	Yes
Secondary	Beck Depression	Beck Depression Inventory BDI	6 weeks	Yes
Secondary	Third finger to the ground	Third finger of the hand to the ground test to assess the flexibility of the posterior chain.	6 weeks	Yes