Effects of Interferential Therapy on the Mechanisms of Pain in Chronic Low Back Pain Without a Specific Cause

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-8n4hg2
• Date of registration: 05/01/2013
• Primary sponsor: Universidade Cidade de São Paulo - São Paulo, SP, Brazil
• Public title: Effects of Interferential Therapy on the Mechanisms of Pain in Chronic Low Back Pain Without a Specific Cause
• Scientific title: Effects of Carrier Frequency of Interferential Current on Modulation of Pain and Central Hypersensitivity in Patients with Nonspecific Chronic Low Back Pain: Randomized Controlled Trial
• Date of first enrolment: 01/02/2013
• Target sample size: 150
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-8n4hg2/
• Study design: Randomized controlled trial, single blinded trial with three arms

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: Patients presenting nonspecific low back pain for at least 3 months and with at least 3 of pain intensity in verbal numerical pain scale reported according to how they felt in the last 7 days, aged between 18 and 80 years, both genders
Exclusion criteria: Patients with serious spinal diseases, such as fractures, tumors and inflammatory diseases such as ankylosing spondylitis, spinal root conditions confirmed by neurological tests (spondylolisthesis and disc herniation with neurological, narrowing spinal canal and others). Severe cardiorespiratory disease. Neurologial diseases. Pregnancy. Infection in the site of the current application. Cancer. Cardiac pacemaker. Skin lesions at the site of the current application. Alterations in sensibility and allergy in the region of electrodes placement.

Age minimum: 18Y
Age maximum: 80Y
Gender: -

Health Condition(s) or Problem(s) studied

Nonspecific chronic low back pain
C10.597.617.232.400

Intervention(s)

Participants will be randomized into 3 groups: 1 kHz Group (50 participants), 4 kHz Group (50 participants) and Placebo Group (50 participants). All subjects will receive 30 minutes of current stimulation (current off in Placebo) for 4 weeks, three days per week. An electrical stimulator will deliver a medium frequency alternating current and the bipolar technique will be used. The following parameters will be used: carrier frequency in accordance with the allocation group (1 or 4 kHz); AMF = 100 Hz, Sweep F = 50 Hz, 1:1 sweep mode and 30 minutes stimulation.

Primary Outcome(s)

Intensity of pain before, after all sessions, 20 minutes after turning off the current and after 3 months as measured by the numeric pain scale

Secondary Outcome(s)

Pressure pain threshold (PPT) before, at the end of the treatment protocol and 20 minutes after switching off the current. PPTs will be measured with a pressure algometer. Discomfort during current application in all sessions by visual analog scale, disability before, after treatment and after 3 months by Roland Morris questionnaire, the perception of their overall effect before, after treatment and after three months of the overall perception of the scale, the conditioned modulation of pain using the cold pressor test and temporal summation of pain with stimuli pressure at the start of first and the last application. The functionality by sit/stand test before and at the last minute of current in the first and final session.

Secondary ID(s)

019681/2012

04127912.1.0000.0064 - CAAE

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo - São Paulo, SP, Brazil

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

Secondary Sponsor(s)

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