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

• Sponsor: University of Sao Paulo General Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02039037
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Device: Acupuncture; Device: Electroacupuncture (device 585)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 66 participants
• 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
• Study Start Date: Jan 1, 2014
• Anticipated Primary Completion Date: Sep 1, 2015
• Anticipated Study Completion Date: Sep 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Pain [6 weeks]

   Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire

2. Functional Disability [6 weeks]

   Roland Morris Disability Questionnaire

Secondary Outcome Measures

1. 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.

2. Quality of life [6 weeks]

   Short-Form Health Survey Questionnaire

3. Global Perceived Effect [6 weeks]

   Global Perceived Effect Scale

4. Beck Depression [6 weeks]

   Beck Depression Inventory BDI

5. Third finger to the ground [6 weeks]

   Third finger of the hand to the ground test to assess the flexibility of the posterior chain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Medicine School of the University Of São Paulo	Sao paulo	SP	Brazil	01246903

Sponsors and Collaborators

• University of Sao Paulo General Hospital

Investigators

• Principal Investigator: Josielli Comachio, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: josicomachio
• First Posted: Jan 17, 2014
• Last Update Posted: Apr 3, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Apr 3, 2015