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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Ultrasound plus Laser and therapeutic exercise; Device: Ultrasound plus Laser; Device: Utrasound plus Laser Placebo

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Carlos, São Paulo, Brazil
      • Alessandra Rossi Paolillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device and exercise; Device with ultrasound and laser associated with therapeutic exercise	Device: 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.
Experimental: Device; Device with ultrasound and laser	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.
Placebo Comparator: Placebo; Without any treatment	Device: Utrasound plus Laser Placebo; The device with Ultrasound and infrared laser without emitting electromagnetic or mechanical waves was applied (null dose).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Study Director: Alessandra R Paolillo, Ph.D, Physics Institute of São Carlos (IFSC), University of São Paulo (USP); Principal Investigator: Jéssica João, PT, Physics Institute of São Carlos (IFSC), University of São Paulo (USP); Principal Investigator: Herbert João, Msc, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Optics and Photonics Research Center

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: May 24, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Ultrasound; Rehabilitation; Osteoarthritis; Laser; Therapeutic exercise
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: FAPESP2013