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

Study Overview
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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.

Official Title
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Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality in Women With Hand or Knee Osteoarthritis.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Ultrasound plus Laser and therapeutic exercise
* Device: Ultrasound plus Laser
* Device: Utrasound plus Laser Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device and exercise<br>Device with ultrasound and laser associated with therapeutic exercise | Device: Ultrasound plus Laser and therapeutic exercise<br>* 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.<br>|
| Experimental: Device<br>Device with ultrasound and laser | Device: Ultrasound plus Laser<br>* Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The treatments are done once a week, for 3 months.<br>|
| Placebo Comparator: Placebo<br>Without any treatment | Device: Utrasound plus Laser Placebo<br>* The device with Ultrasound and infrared laser without emitting electromagnetic or mechanical waves was applied (null dose).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of pain for hands and knees | Pressure pain thresholds by algometry (N) | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Laser, Therapeutic exercise, Rehabilitation, Osteoarthritis