Effect of Phototherapy Incorporated Into an Exercise Program on Osteoarthritis of the Knee

Osteoarthritis of the Knee Clinical Trial

Official title:

Effect of Phototherapy Incorporated Into an Exercise Program on Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102347
• Other study ID #: 24568013.0.0000.5511
• Status: Completed
• Phase: N/A
• First received: March 29, 2014
• Last updated: December 2, 2015
• Start date: April 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program on pain, functional capacity, range of motion, muscle strength in individuals with osteoarthritis of the knees. The participants will be allocated to different groups through a randomization process using opaque envelopes containing cards stipulating one of the three following groups: Group A (exercise protocol); Group B (exercise protocol + phototherapy protocol); and Group C (exercise protocol + placebo phototherapy protocol). Phototherapy will be performed on the knees diagnosed with osteoarthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of osteoarthritis of the knee (unilateral) according to criteria of the American College of Rheumatology

• age between 40 and 80 years

• either gender

• knee pain and functional disability for at least six months confirmed by historical medical.

Exclusion Criteria:

• Dementia

• neurological disorder (sensory or motor)

• cancer

• diabetes

• acute adverse health condition

• symptoms of osteoarthritis of the hip

• cardiopulmonary disease that impedes walking

• need for wheelchair or gait-assistance device

• and having received steroids through intra-articular injection or orally in the previous six months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Other:
• exercise

• Phototherapy

Locations

Country	Name	City	State
Brazil	University of Nove de Julho	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	lower limb functionality	Using Extremity Functional Scale	9 months	No
Other	pain	Numeric pain rating scale	9 months	No
Other	level of pressure pain	threshold digital algometer	9 months	No
Other	Timed up-and-go test	dynamic equilibrium	9 months	No
Other	trunk stability	Functional reach test	9 months	No
Primary	physical function	Using the Western Ontario and McMaster Universities Arthritis Index	9 months	No
Secondary	Maximum voluntary isometric contraction	A portable dynamometer will be used to assess muscle contraction.	9 months	No

External Links

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