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

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Ultrasound plus Laser; Device: Ultrasound plus Laser and therapeutic exercise; Device: Utrasound plus Laser Placebo

• Registration Number: NCT02154893
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-05-24
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-03
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device	Ultrasound plus Laser	Device with ultrasound and laser
Device and exercise	Ultrasound plus Laser and therapeutic exercise	Device with ultrasound and laser associated with therapeutic exercise
Placebo	Utrasound plus Laser Placebo	Without any treatment

Primary Outcome Measures

Name	Time	Method
Analysis of pain for hands and knees	3 months	Pressure pain thresholds by algometry (N)

Secondary Outcome Measures

Name	Time	Method
Questionnaire for Osteoarthritis	3 months	AUSCAN, WOMAC, KOOS, LEQUESNE index
Jebsen-Taylor Hand Function Test	3 months	The time (s) to perform different activities is registered
Box and block Hand Function Test	3 months	The number of wooden blocks that can be transported from one compartement of a box to another within 1 min is counted
Toe-Touching Function Test	3 months	The distance (cm) from the finger of hand to finger of foot is registered
Sit-to-Stand Function Test	3 months	The number of sit-to-stand within 1 min is counted
Gait Function Test	3 months	The time (s) to perform 10 meters walked is registered
Subjective pain scale for hands and knees	3 months	Pain intensity by visual analog scale (VAS)
Balance Function Test	3 months	The time (s) to perform static and dynamic balance is registered
Dynamometry	3 months	Strength (N)
Quality of life Questionnaire	3 months	SF36
Accelerometer	3 months	Acceleration (km.h-1)
Electrogoniometry	3 months	Range of motion (angle)

Trial Locations

Locations (1)

Alessandra Rossi Paolillo; 🇧🇷 São Carlos, São Paulo, Brazil