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

NCT ID: NCT02102347

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis of the Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

Phototherapy

Intervention Type OTHER

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.

Group Type PLACEBO_COMPARATOR

exercise

Intervention Type OTHER

Phototherapy

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

exercise

Intervention Type OTHER

Phototherapy

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cid André Fidelis de Paula Gomes

Mcs

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Nove de Julho

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24919587 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24568013.0.0000.5511

Identifier Type: -

Identifier Source: org_study_id