Efficacy of Acupuncture and Electroacupuncture in Patients With Chronic Nonspecific Low Back Pain: Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Pain
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- 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
Arms & Interventions
Acupuncture group
This group perform acupuncture needles brand Dong Bang 20x15 in specific spots for the treatment of low back pain.
Intervention: Acupuncture (Device)
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.
Intervention: Electroacupuncture (device 585) (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Scale of Kinesiophobia (TSK)(6 weeks)
- Quality of life(6 weeks)
- Global Perceived Effect(6 weeks)
- Beck Depression(6 weeks)
- Third finger to the ground(6 weeks)
Investigators
JOSIELLI COMACHIO
Efficacy of Acupuncture and Electroacupuncture in patients with chronic nonspecific low back pain: randomized clinical trial
University of Sao Paulo