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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device and exercise

Device with ultrasound and laser associated with therapeutic exercise

Group Type EXPERIMENTAL

Ultrasound plus Laser and therapeutic exercise

Intervention Type DEVICE

Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The resistance training was performed.The treatments are done once a week, for 3 months.

Device

Device with ultrasound and laser

Group Type EXPERIMENTAL

Ultrasound plus Laser

Intervention Type DEVICE

Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The treatments are done once a week, for 3 months.

Placebo

Without any treatment

Group Type PLACEBO_COMPARATOR

Utrasound plus Laser Placebo

Intervention Type DEVICE

The device with Ultrasound and infrared laser without emitting electromagnetic or mechanical waves was applied (null dose).

Interventions

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Ultrasound plus Laser and therapeutic exercise

Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The resistance training was performed.The treatments are done once a week, for 3 months.

Intervention Type DEVICE

Ultrasound plus Laser

Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The treatments are done once a week, for 3 months.

Intervention Type DEVICE

Utrasound plus Laser Placebo

The device with Ultrasound and infrared laser without emitting electromagnetic or mechanical waves was applied (null dose).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Fernanda Rossi Paolillo

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR