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

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ClinicalTrials.gov Identifier: NCT02102347
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Cid André Fidelis de Paula Gomes, University of Nove de Julho

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Other: exercise Other: Phototherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Phototherapy Incorporated Into an Exercise Program on Osteoarthritis of the Knee
Study Start Date : April 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: exercise group
An exercise program will be performed to increase range of motion, improve motor learning and strengthen the muscles of the lower limb. The program will include exercises 2 times a week for four weeks. The first week the exercises will be performed with 2 sets of 15 repetitions and the remaining weeks 3 sets of 15 repetitions for each exercise. To exercise will be performed with the resistance of cinnamon, It will be recommended weight by 70% of one repetition maximum painless assigned individually per patient.
Other: exercise
Experimental: phototherapy group
And, Phototherapy will be administered with a portable nine-diode cluster. The portable nine-diode cluster will be used overlapping three quadrants of the knee in random sequence: medial quadrant, lateral quadrant and posterior quadrant.with one 905-nm diode (mean power: 1 milliwatt ; peak power: 10 megawatt; spot size: 0.44 cm2), four 875-nm diodes (mean power of each diode: 17.5 milliwatt; spot size: 1 cm2) and four 670-nm diodes (mean power of each diode: 15 mW; spot size: 1 cm2); frequency: 1000 Hz; 300-second irradiation time in each quadrant; total energy: 39.3 Joules per quadrant. Phototherapy will be included in the exercises group.
Other: exercise
Other: Phototherapy
Placebo Comparator: Phototherapy placebo
Phototherapy will be administered with a portable nine-diode cluster. The portable nine-diode cluster will be used overlapping three quadrants of the knee in random sequence: medial quadrant, lateral quadrant and posterior quadrant), with one 905-nm diode (mean power: 0 milliwatt; peak power: 0 watt; spot size: 0.44 cm2), four 875-nm diodes (mean power of each diode: 0 milliwatt; spot size: 1 cm2) and four 670-nm diodes (mean power of each diode: 0 milliwatt; spot size: 1 cm2); frequency: 0 Hz; 300-second irradiation time in each quadrant; total energy: 0 Joules per quadrant. Phototherapy will be included in the exercises group.
Other: exercise
Other: Phototherapy



Primary Outcome Measures :
  1. physical function [ Time Frame: 9 months ]
    Using the Western Ontario and McMaster Universities Arthritis Index


Secondary Outcome Measures :
  1. Maximum voluntary isometric contraction [ Time Frame: 9 months ]
    A portable dynamometer will be used to assess muscle contraction.


Other Outcome Measures:
  1. lower limb functionality [ Time Frame: 9 months ]
    Using Extremity Functional Scale

  2. pain [ Time Frame: 9 months ]
    Numeric pain rating scale

  3. level of pressure pain [ Time Frame: 9 months ]
    threshold digital algometer

  4. Timed up-and-go test [ Time Frame: 9 months ]
    dynamic equilibrium

  5. trunk stability [ Time Frame: 9 months ]
    Functional reach test



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102347


Locations
Brazil
University of Nove de Julho
São Paulo, Brazil, 01504-001
Sponsors and Collaborators
University of Nove de Julho

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cid André Fidelis de Paula Gomes, Mcs, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02102347     History of Changes
Other Study ID Numbers: 24568013.0.0000.5511
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Cid André Fidelis de Paula Gomes, University of Nove de Julho:
Physical Therapy Modalities
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases