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Clinical Trials/NCT02039037
NCT02039037
Unknown
Not Applicable

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

University of Sao Paulo General Hospital1 site in 1 country66 target enrollmentJanuary 2014
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
University of Sao Paulo General Hospital
Enrollment
66
Locations
1
Primary Endpoint
Pain
Last Updated
11 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
September 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

JOSIELLI COMACHIO

Efficacy of Acupuncture and Electroacupuncture in patients with chronic nonspecific low back pain: randomized clinical trial

University of Sao Paulo

Eligibility Criteria

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

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)

Study Sites (1)

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