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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154893
• Other study ID #: FAPESP2013
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2014
• Last updated: December 3, 2015
• Start date: January 2014
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Brazil	Alessandra Rossi Paolillo	São Carlos	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of pain for hands and knees	Pressure pain thresholds by algometry (N)	3 months	Yes
Secondary	Subjective pain scale for hands and knees	Pain intensity by visual analog scale (VAS)	3 months	Yes
Secondary	Jebsen-Taylor Hand Function Test	The time (s) to perform different activities is registered	3 months	Yes
Secondary	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	Yes
Secondary	Toe-Touching Function Test	The distance (cm) from the finger of hand to finger of foot is registered	3 months
Secondary	Sit-to-Stand Function Test	The number of sit-to-stand within 1 min is counted	3 months	Yes
Secondary	Gait Function Test	The time (s) to perform 10 meters walked is registered	3 months	Yes
Secondary	Balance Function Test	The time (s) to perform static and dynamic balance is registered	3 months	Yes
Secondary	Dynamometry	Strength (N)	3 months	Yes
Secondary	Accelerometer	Acceleration (km.h-1)	3 months	Yes
Secondary	Electrogoniometry	Range of motion (angle)	3 months	Yes
Secondary	Quality of life Questionnaire	SF36	3 months	Yes
Secondary	Questionnaire for Osteoarthritis	AUSCAN, WOMAC, KOOS, LEQUESNE index	3 months	Yes

External Links

•   Optics and Photonics Research Center