Electroacupuncture and Manual Acupuncture in Patients With Knee Osteoarthritis

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-9tcn2x
• Date of registration: 29/11/2012
• Primary sponsor: Universidade Cidade de São Paulo - São Paulo, SP, Brazil
• Public title: Electroacupuncture and Manual Acupuncture in Patients With Knee Osteoarthritis
• Scientific title: Electroacupuncture and Manual Acupuncture in Patients With Knee Osteoarthritis: Randomized Controlled Trial
• Date of first enrolment: 01/06/2012
• Target sample size: 60
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-9tcn2x/
• Study design: Therapeutic, parallel, two arms, single-blinded, randomized clinical trial

Countries of recruitment

Brazil

Contacts

• Name: Richard Liebano
• Affiliation: Universidade Cidade de São Paulo

• Name: Richard Liebano
• Affiliation: Universidade Cidade de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: Pacients with knee pain, with minimal intensity 2 in visual analogic scale (0-10); Radiographic exam showing knee ostearthritis degree II, III or IV accordingly Kelgren and Lawrence classification
Exclusion criteria: Patients with a history of cancer; dementia; neurological deficits (sensory or motor); cardiac pacemaker; decompensated type I diabetes; uncontrolled systemic arterial hypertension; morbid obesity; currently taking antidepressants; anti-inflammatory steroids in the last six months; tranquilizers; and that are currently under physiotherapy sessions

Age minimum: 40Y
Age maximum: 80Y
Gender: -

Health Condition(s) or Problem(s) studied

Pacients with knee osteoarthritis, arthralgia, acupuncture analgesia
E02.190.044.105
C05.550.114.606.500

Intervention(s)

Therapeutic randomized clinical trial, with 2 arms, single-blind. Randomization will be performed using the permuted-block method with sequentially numbered, opaque sealed envelopes (SNOSE). G1=Eletroacupuncture treatment (n=30): signal 3 with two frequencies: 3 and 100 Hz, with 3 s to each frequency during 30 minutes. G2 = Manual Acupuncture treatment (n=30): technique with handling every 3 minutes after placing the needles for 30 minutes. Points used in both treatments are: LI-4, F-3 bilaterally and E-36, E-35, Xiyan and BP-10 on the affected side. Both groups will receive different treatments. Thus there will not be placebo intervention. The following assessments will be performed immediately before and after treatments (in the same day): a) Pain intensity assessement with a visual analog scale; b) Pressure pain threshold measurement with a pressure algometer; c) Peak of knee extensor torque with an isokinetic dinamometer; d) Mobility assessment with the Timed Up and Go Test. All the assessments will be performed by an investigator not involved in treatments and he will be blind to participant´s group allocation. Due to the nature of interventions it will not be possible to blind participants and therapist. Treatment sessions will be performed during afternoon between June and December of 2012

Primary Outcome(s)

Pain intensity decreased assessed by visual analog scale before and after manual acupuncture and electroacupuncture sessions. It is expected that visual analog scale show lower values after treatments

Secondary Outcome(s)

Pressure pain threshold increase, measured by a pressure algometer; Peak of Torque increase, measured with a isokinetic dynamometer; Deacrese of time to perform the Timed UP & Go test

Secondary ID(s)

CAAE 0082.0.186.000-11

Protocolo 13610113

Source(s) of Monetary Support

Universidade Cidade de São Paulo - São Paulo, SP, Brazil

Secondary Sponsor(s)

Ralph Plaster - São Paulo, SP, Brazil