Effect of Phototherapy Incorporated Into an Exercise Program on Osteoarthritis of the Knee
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedDecember 3, 2015
December 1, 2015
1.5 years
March 29, 2014
December 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
physical function
Using the Western Ontario and McMaster Universities Arthritis Index
9 months
Secondary Outcomes (1)
Maximum voluntary isometric contraction
9 months
Other Outcomes (5)
lower limb functionality
9 months
pain
9 months
level of pressure pain
9 months
- +2 more other outcomes
Study Arms (3)
exercise group
EXPERIMENTALAn 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.
phototherapy group
EXPERIMENTALAnd, 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.
Phototherapy placebo
PLACEBO COMPARATORPhototherapy 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nove de Julho
São Paulo, São Paulo, 01504-001, Brazil
Related Publications (1)
Coelho Cde F, Leal-Junior EC, Biasotto-Gonzalez DA, Bley AS, de Carvalho Pde T, Politti F, Gonzalez Tde O, de Oliveira AR, Frigero M, Garcia MB, Dibai-Filho AV, Gomes CA. Effectiveness of phototherapy incorporated into an exercise program for osteoarthritis of the knee: study protocol for a randomized controlled trial. Trials. 2014 Jun 11;15:221. doi: 10.1186/1745-6215-15-221.
PMID: 24919587DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mcs
Study Record Dates
First Submitted
March 29, 2014
First Posted
April 2, 2014
Study Start
April 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
December 3, 2015
Record last verified: 2015-12