Efficacy of Acupuncture and Electroacupuncture in Patients With Chronic Nonspecific Low Back Pain: Randomized Clinical Trial
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Acupuncture
Electroacupuncture (device 585)
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
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
Sites / Locations
- Medicine School of the University Of São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Acupuncture group
Electroacupuncture group
Arm Description
This group perform acupuncture needles brand Dong Bang 20x15 in specific spots for the treatment of low back pain.
Electro Group, will be added through the use of electrical stimulation of electroacupuncture using the apparatus Accurate pulse 585 at the same points.
Outcomes
Primary Outcome Measures
Pain
Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire
Functional Disability
Roland Morris Disability Questionnaire
Secondary Outcome Measures
Scale of Kinesiophobia (TSK)
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
Short-Form Health Survey Questionnaire
Global Perceived Effect
Global Perceived Effect Scale
Beck Depression
Beck Depression Inventory BDI
Third finger to the ground
Third finger of the hand to the ground test to assess the flexibility of the posterior chain.
Full Information
NCT ID
NCT02039037
First Posted
October 30, 2013
Last Updated
April 2, 2015
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02039037
Brief Title
Efficacy of Acupuncture and Electroacupuncture in Patients With Chronic Nonspecific Low Back Pain: Randomized Clinical Trial
Official Title
Efficacy of Acupuncture and Electroacupuncture in Patients With Chronic Nonspecific Low Back Pain: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture group
Arm Type
Active Comparator
Arm Description
This group perform acupuncture needles brand Dong Bang 20x15 in specific spots for the treatment of low back pain.
Arm Title
Electroacupuncture group
Arm Type
Active Comparator
Arm Description
Electro Group, will be added through the use of electrical stimulation of electroacupuncture using the apparatus Accurate pulse 585 at the same points.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture Group, which will hold acupuncture needles brand Dong Bang 20x15 in specific spots for the treatment of low back pain.
Intervention Type
Device
Intervention Name(s)
Electroacupuncture (device 585)
Intervention Description
Electro will be added through the use of electrical stimulation to the Electro Accurate use of the device 585 at the same points Pulse.
Primary Outcome Measure Information:
Title
Pain
Description
Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire
Time Frame
6 weeks
Title
Functional Disability
Description
Roland Morris Disability Questionnaire
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Scale of Kinesiophobia (TSK)
Description
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.
Time Frame
6 weeks
Title
Quality of life
Description
Short-Form Health Survey Questionnaire
Time Frame
6 weeks
Title
Global Perceived Effect
Description
Global Perceived Effect Scale
Time Frame
6 weeks
Title
Beck Depression
Description
Beck Depression Inventory BDI
Time Frame
6 weeks
Title
Third finger to the ground
Description
Third finger of the hand to the ground test to assess the flexibility of the posterior chain.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélia P Marques, PHD
Email
pasqual@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Josielli Comachio
Email
josiellicomachio@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josielli Comachio
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicine School of the University Of São Paulo
City
Sao paulo
State/Province
SP
ZIP/Postal Code
01246903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josielli Comachio
Phone
+5511987246899
Email
josiellicomachio@usp.br
12. IPD Sharing Statement
Citations:
PubMed Identifier
26472590
Citation
Comachio J, Oliveira Magalhaes M, Nogueira Burke T, Vidal Ramos LA, Peixoto Leao Almeida G, Silva AP, Ferreira de Meneses SR, Costa-Frutuoso JR, Santos Miotto Amorim C, Pasqual Marques A. Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial. Trials. 2015 Oct 15;16:469. doi: 10.1186/s13063-015-0850-7.
Results Reference
derived
Learn more about this trial
Efficacy of Acupuncture and Electroacupuncture in Patients With Chronic Nonspecific Low Back Pain: Randomized Clinical Trial
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