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

NCT02154893 | Completed Phase 2 DMC

• 1 other identifier: FAPESP2013
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Ultrasound; Laser; Therapeutic exercise; Rehabilitation; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Analysis of pain for hands and knees

  Pressure pain thresholds by algometry (N)

  3 months

Secondary Outcomes (12)

• Subjective pain scale for hands and knees

  3 months

• Jebsen-Taylor Hand Function Test

  3 months

• Box and block Hand Function Test

  3 months

• Toe-Touching Function Test

  3 months

• Sit-to-Stand Function Test

  3 months

Study Arms (3)

Device and exercise

EXPERIMENTAL

Device with ultrasound and laser associated with therapeutic exercise

Device: Ultrasound plus Laser and therapeutic exercise

Device

EXPERIMENTAL

Device with ultrasound and laser

Device: Ultrasound plus Laser

Placebo

PLACEBO COMPARATOR

Without any treatment

Device: Utrasound plus Laser Placebo

Interventions

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.

Device and exercise

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.

Device

Utrasound plus Laser Placebo DEVICE

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

Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian women
• Aged between 60 and 80 years
• Hand osteoarthritis
• Knee osteoarthritis

You may not qualify if:

• Psychiatric disorder,
• Neurological disease
• Metabolic disease
• Pulmonary disease
• Cardiac disease,
• Thrombosis
• Cancer.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Alessandra Rossi Paolillo

São Carlos, São Paulo, Brazil

Location

Related Publications (5)

• 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.

  PMID: 15704096 RESULT

• 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.

  PMID: 17629805 RESULT

• 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.

  PMID: 16616270 RESULT

• 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.

  PMID: 18853213 RESULT

• 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.

  PMID: 20925995 RESULT

Related Links

• Optics and Photonics Research Center

MeSH Terms

Conditions

Osteoarthritis

Interventions

Ultrasonography; Lasers; Exercise Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Vanderlei S Bagnato, Ph.D

  Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

  STUDY DIRECTOR

• Alessandra R Paolillo, Ph.D

  Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

  STUDY DIRECTOR

• Fernanda 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: May 24, 2014
• First Posted: June 3, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 4, 2015

Record last verified: 2014-05

Locations

BR (1)