Low Power Laser and Exercise in Osteoarthritis of the Knee: a Randomized Clinical Trial

NCT01306435 | Completed Phase 2 DMC

• 1 other identifier: 077508
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Indroduction: Knee osteoarthritis (OA) is a painful condition causing disability, weakness and poor quality of live. The results are very consistent about the benefits of laser and exercises to improve pain and function in subjects with knee osteoarthritis Objectives: To investigate the effects of Low Power Laser (LBP) associated with exercise in pain, function, range of motion, muscle strength and quality of life of patients with knee osteoarthritis. Methods: Forty patients of both sexes aged between 50 and 75 years with knee osteoarthritis (grade 2-4) were randomized into two groups: Laser-LBP-active dose of 3J more exercises and Group Placebo-LBP- placebo and exercise. Were evaluated for pain, function, range of motion, muscle strength and quality of life on three occasions: before starting treatment (evaluation 1), 3 weeks after laser application (evaluation 2) and 8 weeks after completion of exercise (evaluation 3). There were 33 physical therapy sessions three times a week, on March 1 and the laser was applied in the other, only the exercises.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Low Power Laser Therapy; Exercise; Knee

Outcome Measures

Primary Outcomes (1)

• Change from baseline in VAS at 3 and 8 weeks

  In the VAS the subject marks the intensity of its pain in a centimeter horizontal line

  baseline, 3 and 8 weeks

Secondary Outcomes (4)

• Change from baseline in Lequesne at 3 an 8 weeks

  baseline, 3 and 8 weeks

• Change from baseline in range of motion

  baseline, 3 and 8 weeks

• Change from baseline in Muscular Strength at 3 and 8 weeks

  baseline, 3 and 8 weeks

• Change from baseline in Quality of Life at 3 and 8 weeks

  baseline, 3 and 8 weeks

Study Arms (2)

Laser Group

EXPERIMENTAL

Other: Laser

Placebo Group

PLACEBO COMPARATOR

Other: Placebo Laser

Interventions

Laser OTHER

3-week treatment with three Laser sessions per week

Also known as: LOW POWER LASER

Laser Group

Placebo Laser OTHER

3-week treatment with three Placebo Laser sessions per week

Also known as: PLACEBO LOW POWER LASER

Placebo Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnoses of osteoarthritis
• Knee pain
• Functional reduction in the last three months
• Grade 2-4 OA
• Fulfilled at least one of the classification criteria of the American College of Rheumatology

You may not qualify if:

• Cancer
• Diabetes mellitus
• Symptomatic hip OA
• Antidepressants
• Anti-inflammatory steroidal and nonsteroidal or tranquilizers in the last six months and throughout the treatment

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of São Paulo General Hospital

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis; Motor Activity

Interventions

Lasers; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Patrícia P Alfredo, MS

  Faculty of Medicine of the University of São Paulo

  PRINCIPAL INVESTIGATOR

• Amélia P Marques, PhD

  Faculty of Medicine of the University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: March 1, 2011
• Study Start: November 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: March 1, 2011

Record last verified: 2011-02

Locations

BR (1)