Clinical trial NCT02154893: Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality
Official title: Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality in Women With Hand or Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Ultrasound
Laser
Therapeutic exercise
Rehabilitation
Osteoarthritis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-06-03
Enrollment: 90
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Analysis of pain for hands and knees
timeFrame: 3 months
Secondary outcomes:
measure: Subjective pain scale for hands and knees
timeFrame: 3 months
measure: Jebsen-Taylor Hand Function Test
timeFrame: 3 months
measure: Box and block Hand Function Test
timeFrame: 3 months
measure: Toe-Touching Function Test
timeFrame: 3 months
measure: Sit-to-Stand Function Test
timeFrame: 3 months
measure: Gait Function Test
timeFrame: 3 months
measure: Balance Function Test
timeFrame: 3 months
measure: Dynamometry
timeFrame: 3 months
measure: Accelerometer
timeFrame: 3 months
measure: Electrogoniometry
timeFrame: 3 months
measure: Quality of life Questionnaire
timeFrame: 3 months
measure: Questionnaire for Osteoarthritis
timeFrame: 3 months
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Alessandra Rossi Paolillo
state: São Paulo
Study officials:
affiliation: Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
name: Vanderlei S Bagnato, Ph.D
role: STUDY_DIRECTOR
affiliation: Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
name: Alessandra R Paolillo, Ph.D
role: STUDY_DIRECTOR
affiliation: Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
name: Fernanda R Paolillo, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
name: Jéssica João, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
name: Herbert João, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brosseau L, Wells G, Marchand S, Gaboury I, Stokes B, Morin M, Casimiro L, Yonge K, Tugwell P. Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand. Lasers Surg Med. 2005 Mar;36(3):210-9. doi: 10.1002/lsm.20137.
citation: Ekim A, Armagan O, Tascioglu F, Oner C, Colak M. Effect of low level laser therapy in rheumatoid arthritis patients with carpal tunnel syndrome. Swiss Med Wkly. 2007 Jun 16;137(23-24):347-52. doi: 10.4414/smw.2007.11581.
citation: Allen RJ. Physical agents used in the management of chronic pain by physical therapists. Phys Med Rehabil Clin N Am. 2006 May;17(2):315-45. doi: 10.1016/j.pmr.2005.12.007.
citation: Korstjens CM, van der Rijt RH, Albers GH, Semeins CM, Klein-Nulend J. Low-intensity pulsed ultrasound affects human articular chondrocytes in vitro. Med Biol Eng Comput. 2008 Dec;46(12):1263-70. doi: 10.1007/s11517-008-0409-9. Epub 2008 Oct 14.
citation: Tascioglu F, Kuzgun S, Armagan O, Ogutler G. Short-term effectiveness of ultrasound therapy in knee osteoarthritis. J Int Med Res. 2010 Jul-Aug;38(4):1233-42. doi: 10.1177/147323001003800404.