Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis

Treatments: Device: Ultrasound plus Laser; Device: Utrasound plus Laser Placebo; Device: Ultrasound plus Laser and therapeutic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02154893

FAPESP2013

Details and patient eligibility

About

There are several therapeutic effects of the ultrasound (US) or low level laser therapy (LLLT), including pain relief, increase of microcirculation, modulation of inflammatory response and accelerated tissue repair. The investigators hypothesis was that a combination of US, LLLT and therapeutic exercise may maximize clinical outcome.

Full description

Patients with pain, especially chronic pain, avoid movements. This is turn results in a gradual impairment of their physical condition, reducing, for example, strength, flexibility, physical functionality and occupational activity. To performed physical treatments, a prototype device was development. The device includes four diode laser beams (808 nm) around of the one ultrasound transducer.

Enrollment: 90 patients

Sex: Female

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Caucasian women
• Aged between 60 and 80 years
• Hand osteoarthritis
• Knee osteoarthritis

Exclusion criteria

• Psychiatric disorder,
• Neurological disease
• Metabolic disease
• Pulmonary disease
• Cardiac disease,
• Thrombosis
• Cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups, including a placebo group

Device and exercise

Experimental group

Description:

Device with ultrasound and laser associated with therapeutic exercise

Treatment:

Device: Ultrasound plus Laser and therapeutic exercise

Device

Experimental group

Description:

Device with ultrasound and laser

Treatment:

Device: Ultrasound plus Laser

Placebo

Placebo Comparator group

Description:

Without any treatment

Treatment:

Device: Utrasound plus Laser Placebo