Efficacy of Acupuncture and Electroacupuncture in Patients With Chronic Nonspecific Low Back Pain: Randomized Clinical Trial
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|ClinicalTrials.gov Identifier: NCT02039037|
Recruitment Status : Unknown
Verified April 2015 by JOSIELLI COMACHIO, University of Sao Paulo.
Recruitment status was: Recruiting
First Posted : January 17, 2014
Last Update Posted : April 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Device: Acupuncture Device: Electroacupuncture (device 585)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of Acupuncture and Electroacupuncture in Patients With Chronic Nonspecific Low Back Pain: Randomized Clinical Trial|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2016|
Active Comparator: Acupuncture group
This group perform acupuncture needles brand Dong Bang 20x15 in specific spots for the treatment of low back pain.
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.
- Pain [ Time Frame: 6 weeks ]Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire
- Functional Disability [ Time Frame: 6 weeks ]Roland Morris Disability Questionnaire
- Scale of Kinesiophobia (TSK) [ Time Frame: 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.
- Quality of life [ Time Frame: 6 weeks ]Short-Form Health Survey Questionnaire
- Global Perceived Effect [ Time Frame: 6 weeks ]Global Perceived Effect Scale
- Beck Depression [ Time Frame: 6 weeks ]Beck Depression Inventory BDI
- Third finger to the ground [ Time Frame: 6 weeks ]Third finger of the hand to the ground test to assess the flexibility of the posterior chain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039037
|Medicine School of the University Of São Paulo||Recruiting|
|Sao paulo, SP, Brazil, 01246903|
|Contact: Josielli Comachio +5511987246899 firstname.lastname@example.org|
|Principal Investigator:||Josielli Comachio||University of Sao Paulo|