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

U

University of Sao Paulo General Hospital

Status

Unknown

Conditions

Low Back Pain

Treatments

Device: Acupuncture
Device: Electroacupuncture (device 585)

Study type

Interventional

Funder types

Other

Identifiers

NCT02039037
josicomachio

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Josielli Comachio; Amélia P Marques, PHD

Data sourced from clinicaltrials.gov

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