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Completed

NCT Number: NCT02154893

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Alessandra Rossi Paolillo

São Carlos, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound plus Laser and therapeutic exercise

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.

Ultrasound plus Laser

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.

Utrasound plus Laser Placebo

Device

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

Primary outcomes

  1. Analysis of pain for hands and knees

    Time frame: 3 months

    Pressure pain thresholds by algometry (N)

Secondary outcomes

  1. Subjective pain scale for hands and knees

    Time frame: 3 months

    Pain intensity by visual analog scale (VAS)

  2. Jebsen-Taylor Hand Function Test

    Time frame: 3 months

    The time (s) to perform different activities is registered

  3. Box and block Hand Function Test

    Time frame: 3 months

    The number of wooden blocks that can be transported from one compartement of a box to another within 1 min is counted

  4. Toe-Touching Function Test

    Time frame: 3 months

    The distance (cm) from the finger of hand to finger of foot is registered

  5. Sit-to-Stand Function Test

    Time frame: 3 months

    The number of sit-to-stand within 1 min is counted

  6. Gait Function Test

    Time frame: 3 months

    The time (s) to perform 10 meters walked is registered

  7. Balance Function Test

    Time frame: 3 months

    The time (s) to perform static and dynamic balance is registered

  8. Dynamometry

    Time frame: 3 months

    Strength (N)

  9. Accelerometer

    Time frame: 3 months

    Acceleration (km.h-1)

  10. Electrogoniometry

    Time frame: 3 months

    Range of motion (angle)

  11. Quality of life Questionnaire

    Time frame: 3 months

    SF36

  12. Questionnaire for Osteoarthritis

    Time frame: 3 months

    AUSCAN, WOMAC, KOOS, LEQUESNE index

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 3, 2014
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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