Clinical trial NCT02039037: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain
timeFrame: 6 weeks
measure: Functional Disability
timeFrame: 6 weeks
Secondary outcomes:
measure: Scale of Kinesiophobia (TSK)
timeFrame: 6 weeks
measure: Quality of life
timeFrame: 6 weeks
measure: Global Perceived Effect
timeFrame: 6 weeks
measure: Beck Depression
timeFrame: 6 weeks
measure: Third finger to the ground
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sao paulo
country: Brazil
facility: Medicine School of the University Of São Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Josielli Comachio
role: PRINCIPAL_INVESTIGATOR
References:
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.